A Study in Participants With Asthma Initiating Treatment With Omalizumab (Xolair)

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT01922037

Collaborator

(none)

806

Enrollment

145

Locations

Arm

33.4

Actual Duration (Months)

5.6

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This multicenter, prospective study will evaluate the baseline participant characteristics (including biomarkers) associated with a variety of individual and composite clinical outcomes in participants with moderate to severe asthma initiating treatment with omalizumab.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Omalizumab	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

806 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective Observational Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab

Actual Study Start Date :

Jun 19, 2013

Actual Primary Completion Date :

Mar 31, 2016

Actual Study Completion Date :

Mar 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Participants With Allergic Asthma Participants with allergic asthma, who have decided to initiate treatment with omalizumab will be observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurs first.	Drug: Omalizumab Participants will receive omalizumab for up to 12 months per investigator standard of care and clinical practice. Other Names: Xolair

Arm

Intervention/Treatment

Experimental: Participants With Allergic Asthma

Participants with allergic asthma, who have decided to initiate treatment with omalizumab will be observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurs first.

Drug: Omalizumab

Participants will receive omalizumab for up to 12 months per investigator standard of care and clinical practice.

Other Names:

Xolair

Outcome Measures

Primary Outcome Measures

Total Number of Asthma Exacerbations During Months 1-12 [Months 1-12]
An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.

Secondary Outcome Measures

Total Number of Asthma Exacerbations During Months 1-6 [Months 1-6]
An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/=3 days.
Total Number of Asthma Exacerbations During Months 7-12 [Months 7-12]
An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.
Total Number of Asthma-Related Hospital Admissions During Months 1-12 [Months 1-12]
Total Number of Asthma-Related Hospital Admissions During Months 1-6 [Months 1-6]
Total Number of Asthma-Related Hospital Admissions During Months 7-12 [Months 7-12]
Total Number of Asthma-Related ER Visits During Months 1-12 [Months 1-12]
Total Number of Asthma-Related Emergency Room (ER) Visits During Months 1-6 [Months 1-6]
Total Number of Asthma-Related ER Visits During Months 7-12 [Months 7-12]
Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-12 [Months 1-12]
Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-6 [Months 1-6]
Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 7-12 [Months 7-12]
Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-12 [Months 1-12]
Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-6 [Months 1-6]
Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 7-12 [Months 7-12]
Percentage of Participants by Number of Asthma Exacerbations [Months 1-12]
Percentage of participants by number of asthma exacerbations (0, 1, 2, 3, >/=4) was reported. An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.
Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids [Months 1-12]
Percentage of participants by number of asthma exacerbations (0, 1, 2, 3, >/=4) requiring treatment with systemic steroids was reported. An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.
Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1) [Baseline, Month 6, end of study (EOS)/early termination (ET) (up to Month 12)]
FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. Pre-bronchodilator FEV1 and post-bronchodilator FEV1 are reported for each timepoint. FEV1 was measured using spirometry.
Change From Baseline in Raw Forced Vital Capacity (FVC) [Baseline, Month 6, EOS/ET (up to Month 12)]
FVC was defined as the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pre-bronchodilator FVC and post-bronchodilator FVC are reported for each timepoint. FVC was measured using spirometry.
Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%) [Baseline, Month 6, EOS/ET (up to Month 12)]
FEF25%-75% was defined as the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. Pre-bronchodilator FEF25%-75% and post-bronchodilator FEF25%-75% are reported for each timepoint. FEF25%-75% was measured using spirometry.
Change From Baseline in Percentage Predicted FEV1 (ppFEV1) [Baseline, Month 6, EOS/ET (up to Month 12)]
FEV1 is the volume of air that can be forced out in one second after taking a deep breath, as measured using spirometry. Hankinson and Wang standards were used to calculate ppFEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. ppFEV1= 100 multiplied by (*) FEV1 (in liters [L]) divided by (/) predicted FEV1 (in L). Pre-bronchodilator ppFEV1 and post-bronchodilator ppFEV1 are reported for each timepoint.
Percentage of Participants With Prior Asthma Medications by Category or Class of Medications [Baseline]
Prior asthma medications were defined as all medications used for asthma prior to the study (initiated within 90 days of baseline) and were assessed retrospectively at baseline. Participants received prior asthma medications of following categories or classes: short acting beta agonist (SABA), combination inhaled corticosteroids/long acting beta agonist (ICS/LABA), leukotriene receptor antagonist (LTRA), inhaled corticosteroids (ICS), oral/parenteral (systemic) corticosteroids, anticholinergic, long acting beta agonist (LABA), and other medication.
Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications [Baseline until EOS/ET (up to Month 12)]
Concomitant and ongoing asthma medications were defined as all medications used for asthma which began on or after the participant's study start, as well as those ongoing at the beginning of the study. Participants received following categories or classes of concomitant and ongoing asthma medications: SABA, combination ICS/LABA, LTRA, oral/parenteral (systemic) corticosteroids, ICS, anticholinergic, LABA, and other medication.
Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score [Baseline, Month 6, EOS/ET (up to Month 12)]
AQLQ +12 is a 32-item disease specific questionnaire designed to assess the participants' asthma-specific health-related quality of life (QOL). The questionnaire contains four domains: activity limitations (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). All items are scored on a 7-point likert scale. All item scores are averaged to produce one overall QOL score. Overall score ranges from 1 (total impairment) to 7 (no impairment), with higher scores indicating better QOL. A positive change from baseline indicated improved QOL.
Change From Baseline in Asthma Control Test (ACT) Overall Score [Baseline, Months 3, 6, 9, 12]
Multidimensional factors associated with asthma control from the participant's perspective were assessed using the ACT questionnaire. The ACT is a validated, five-item patient-reported outcome (PRO) questionnaire that measures the impact of asthma on home and work activities, shortness of breath, symptoms, rescue medication usage, and overall asthma control. All items are scored on a 5-point likert scale (1 to 5). All item scores are added together to calculate a total score. Total score ranges from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. A positive change from baseline indicated improvement.
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score [Baseline, Month 6, EOS/ET (up to Month 12)]
WPAI-asthma is a self-administered instrument to measure asthma-specific performance impairment of work and regular daily activity within the last 7 days and yields 4 types of scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (WI) (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). Total score and each score ranged from 0 (not affected/no impairment) to 100 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. A negative change in score indicated improvement and a positive change indicated impairment.
Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using Global Evaluation of Treatment Effectiveness (GETE) by Inversigator [EOS/ET (up to Month 12)]
Response to treatment was assessed using the GETE. The GETE is a validated instrument that measures the overall impression of the effect of the study medication on typical asthma symptoms. The evaluation was performed using the 5-point scale. The GETE scale ranges were as follows: 1=excellent, 2=good, 3=moderate, 4=poor, 5= worsening. A good or excellent response on the 5 point scale indicated that a participant had responded to treatment. Percentage of participants who showed an improvement (GETE scale score of 1 or 2) in asthma symptoms, as assessed by investigator, is reported.
Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using GETE by Participant [EOS/ET (up to Month 12)]
Response to treatment was assessed using the GETE. The GETE is a validated instrument that measures the overall impression of the effect of the study medication on typical asthma symptoms. The evaluation was performed using the 5-point scale. The GETE scale ranges were as follows: 1=excellent, 2=good, 3=moderate, 4=poor, 5= worsening. A good or excellent response on the 5 point scale indicated that a participant had responded to treatment. Percentage of participants who showed an improvement (GETE scale score of 1 or 2) in asthma symptoms, as assessed by participant, is reported.
Change From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Quality of Life Score [Baseline, EOS/ET (up to Month 12)]
The MiniRQLQ is a shorter version of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) instrument. The MiniRQLQ is a validated quality of life questionnaire to measure the functional impairments that are most troublesome to adult participants with either seasonal or perennial rhinoconjunctivitis of either allergic or non-allergic origin. The miniRQLQ contains 14 items; each item scored on a 7-point scale ranging from 0 [not impaired at all] to 6 [severely impaired]). The overall quality of life score is the average of the all item scores and ranges from 0 (not impaired at all) to 6 (severely impaired), with higher scores indicating more impairment. A negative change in score indicated improvement and a positive change indicated impairment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants identified by the investigator as a candidate for treatment for asthma with omalizumab
Confirmation of access to omalizumab through insurance or other source of funding

Exclusion Criteria:

Enrollment in any other concurrent clinical trial or observational study
Participants for whom omalizumab treatment is contraindicated
Participants who had a prior allergic reaction to omalizumab or its excipients
Participants treated with omalizumab within the previous year
Participants who received an experimental drug as part of another study within 3 months of enrollment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama Allergy & Asthma	Birmingham	Alabama	United States	35209
2	Achieve Clinical Research, LLC	Birmingham	Alabama	United States	35216
3	Huntsville Lung Associates PC	Huntsville	Alabama	United States	35801
4	San Tan Allergy & Asthma	Gilbert	Arizona	United States	85234-2966
5	Dedicated Clinical Research	Goodyear	Arizona	United States	85395
6	Allergy Associates of Tucson	Tucson	Arizona	United States	85716
7	University of Arizona	Tucson	Arizona	United States	85724-5030
8	Little Rock Allergy & Asthma; Clinical Research Center	Little Rock	Arkansas	United States	72205
9	Stuart Epstein MD - PP	Beverly Hills	California	United States	90212
10	West Coast Clinical Trials Global, LLC	Costa Mesa	California	United States	92626
11	Peninsula Allergy Associates	Daly City	California	United States	94015
12	Allianz Medical and Research Center	Fountain Valley	California	United States	92708
13	William Ebbeling MD - PP	Fresno	California	United States	93720
14	Gettysburg Medical Clinic	Fresno	California	United States	93726
15	Allergy & Asthma Inst Valley	Granada Hills	California	United States	91344
16	VA Loma Linda Healthcare System	Loma Linda	California	United States	92357
17	Allergy Asthma Care Ctr, Inc.	Los Angeles	California	United States	90064
18	Southern California Research Center	Mission Viejo	California	United States	92691
19	North Bay Allergy & Asthma; Medical Assoc	Napa	California	United States	94558
20	Choc Psf, Amc	Orange	California	United States	92868
21	Clinical Trials of Orange County	Orange	California	United States	92868
22	California Allergy & Asthma Medical Group, Inc.	Palmdale	California	United States	93551
23	Joann Blessing-Moore MD - PP	Palo Alto	California	United States	94304
24	TPMG - Rancho Cordova	Rancho Cordova	California	United States	95762
25	Redding Allergy & Asthma Care	Redding	California	United States	96003
26	Allergy & Asthma Consultants	Redwood City	California	United States	94063
27	Capital Allergy Resp Dis Ctr	Sacramento	California	United States	95819
28	Central Coast Allergy and Asthma	Salinas	California	United States	93901
29	Allergy Assoc Medical Group	San Diego	California	United States	92108
30	Kaiser Permanente - San Diego	San Diego	California	United States	92120
31	University of California at San Francisco	San Francisco	California	United States	94115
32	Asthma & Allergy Clinic	San Francisco	California	United States	94121
33	The Allergy and Asthma Clinic	San Mateo	California	United States	94401
34	Allergy & Asthma Medical Group; Clinical Research Division	Walnut Creek	California	United States	94598
35	IMMUNOe International Research Centers	Centennial	Colorado	United States	80112
36	Danbury Hospital	Danbury	Connecticut	United States	06810
37	Christopher C Randolph MD - PP	Waterbury	Connecticut	United States	06708
38	Waterbury Pulmonary Associates	Waterbury	Connecticut	United States	06708
39	St. Francis Sleep; Allergy & Lung Institute	Clearwater	Florida	United States	33765
40	AAADRS; Clinical Research Center	Coral Gables	Florida	United States	33134
41	Allergy Asthma & Immun Center	Leesburg	Florida	United States	34788
42	Florida Ctr-Allergy & Asthma	Miami	Florida	United States	33173
43	FL Ctr Allergy & Asthma Res	Miami	Florida	United States	33176
44	Allergy & Asthma Care of FL; Clinical Research	Ocala	Florida	United States	34471
45	Central Florida Pulmonary Grou	Orlando	Florida	United States	32803
46	Allergy Asthma & Sinus Center	Palm Beach Gardens	Florida	United States	33410
47	Gulf Coast Allergy Center, P.A.	Port Charlotte	Florida	United States	33952
48	USF Asthma Allergy & Immun; Clinical Research	Tampa	Florida	United States	33613
49	Georgia Pollens	Albany	Georgia	United States	31707
50	Brookstone Clinical Res Ctr	Columbus	Georgia	United States	31904
51	Allergy & Asthma Care Center	Gainesville	Georgia	United States	30501
52	Aeroallergy Research Labs	Savannah	Georgia	United States	31406
53	Asthma & Allergy of Idaho	Twin Falls	Idaho	United States	83301
54	Rush University Medical Center	Chicago	Illinois	United States	60612
55	Chest Medicine Consultants	Chicago	Illinois	United States	60657
56	Allergy & Asthma Care LTD	Glen Carbon	Illinois	United States	62034
57	Sneeze Wheeze and Itch Associates LLC	Normal	Illinois	United States	61761
58	Allergy Asthma Care	Crown Point	Indiana	United States	46307
59	The Allergy and Asthma Center	Fort Wayne	Indiana	United States	46804
60	Clinical Research Center of Indiana	Indianapolis	Indiana	United States	46208
61	University of Kansas Med Ctr; Int med/Allgy/Immun/Rheum	Kansas City	Kansas	United States	66160-7350
62	Kansas City Allergy And Asthma Assoc.	Overland Park	Kansas	United States	66210
63	Abraham Research PLLC	Florence	Kentucky	United States	41042
64	Allergy & Asth Phys of Cent KY	Lexington	Kentucky	United States	40503
65	Dr. Paul Shapero	Bangor	Maine	United States	04401
66	Chesapeake Clinical Research Inc - CRN	Baltimore	Maryland	United States	21236
67	Glenn M. Silber, M.D., P.A	Ellicott City	Maryland	United States	21042
68	Family Allergy & Asthma	Gaithersburg	Maryland	United States	20878
69	Brigham and Women's Hospital	Boston	Massachusetts	United States	98410
70	Center for Clinical Research.	Brockton	Massachusetts	United States	02301
71	Allergy Arth Fam Treatment Ctr	Gardner	Massachusetts	United States	01440
72	Infinity Medical Research Inc	North Dartmouth	Massachusetts	United States	02747
73	McGovern & Baja Allergy Assoc	Springfield	Massachusetts	United States	01103
74	Asthma & Allergy Inst of MI	Clinton Township	Michigan	United States	48038
75	Asthma Allergy Ctr of SW MI	Portage	Michigan	United States	49024
76	Clinical Research Inst	Minneapolis	Minnesota	United States	55402
77	Mayo Clinic	Rochester	Minnesota	United States	55905
78	Washington Univ. School of Med	Saint Louis	Missouri	United States	63141
79	Impact Clinical Trials	Las Vegas	Nevada	United States	89106
80	Ocean Allergy & Resp Res Ctr	Brick Township	New Jersey	United States	08724
81	Adult Ped Aller Central Jersey	Edison	New Jersey	United States	08820
82	Center for Asthma and Allergy	Highland Park	New Jersey	United States	08904
83	Atlantic Allergy Asthma Immunology Associates	Ocean City	New Jersey	United States	07712
84	Allergy Treatment Center of New Jersey	Piscataway	New Jersey	United States	08854
85	Pulmonary and Allergy Associates	Summit	New Jersey	United States	07901
86	Allergy Consultants, PA	Verona	New Jersey	United States	07044
87	SUNY Downstate Medical Center.	Brooklyn	New York	United States	11203
88	Boris Sagalovich MD - PC	Brooklyn	New York	United States	11229
89	Island Medical Research Pc	Commack	New York	United States	11725
90	North Shore Medical Arts, LLP	Great Neck	New York	United States	11021
91	Jamaica Hospital Medical Center	Jamaica	New York	United States	11418
92	Winthrop Univ Hospital	Mineola	New York	United States	11501
93	Laura and ISAAC Perlmutter Cancer Center at NYU Langone.	New York	New York	United States	10016
94	Parikh Institute for Research LLC	New York	New York	United States
95	Albert P Hirdt DO - PP	Newburgh	New York	United States	12550
96	Olean Medical Group	Olean	New York	United States	14760
97	University of Rochester	Rochester	New York	United States	14618
98	Advanced Allergy & Asthma PLLC	Rockville Center	New York	United States	11570
99	Urban Health Plan, Inc.	The Bronx	New York	United States	10459
100	Montefiore Medical Center	The Bronx	New York	United States	10461
101	Alan Kaufman MD - PP	The Bronx	New York	United States	10465
102	Allergy Partners of Western NC	Asheville	North Carolina	United States	28801
103	Allergy & Asthma Centre of Dayton	Centerville	Ohio	United States	45458
104	The Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
105	Santiago Reyes MD-Private Prac	Oklahoma City	Oklahoma	United States	73112
106	Vital Prospects Clin Res Pc	Tulsa	Oklahoma	United States	74136
107	Bend Memorial Clinic	Bend	Oregon	United States	97701
108	Central PA Asth & Allergy Care; Research Division	Altoona	Pennsylvania	United States	16601
109	Allergy and Asthmas; Specialists of Harrisburg	Harrisburg	Pennsylvania	United States	17110
110	Penn State Hershey Medical Group	Hershey	Pennsylvania	United States	17033
111	Inst for Resp & Sleep Med PC	Langhorne	Pennsylvania	United States	19047
112	Allergy and Asthma Research of NJ, lnc	Philadelphia	Pennsylvania	United States	19115
113	Allergy & Clinical Immun Assoc	Pittsburgh	Pennsylvania	United States	15241
114	South Hills Pulmonary Assoc	Pittsburgh	Pennsylvania	United States	15243
115	Respiratory Specialists	Reading	Pennsylvania	United States	19610
116	Nat'l Aller Asth-Charleston	Charleston	South Carolina	United States	29406
117	ADAC Research PA	Greenville	South Carolina	United States	29607
118	Upstate Pharma Research	Simpsonville	South Carolina	United States	29681
119	East Tennessee Center for Clinical Research	Knoxville	Tennessee	United States	37909
120	LeBonheur Children's Hospital	Memphis	Tennessee	United States	38103
121	Vanderbilt Medical University	Nashville	Tennessee	United States	37203
122	Greater Austin Allergy Asthma and Immunology	Austin	Texas	United States	78746
123	Elliot J. Ginchansky, MD, PA	Dallas	Texas	United States	75230
124	Allergy Asthma Research Assoc	Dallas	Texas	United States	75231
125	University of Texas Medical Branch;Division of APICS	Galveston	Texas	United States	77555
126	Allergy Asthma & Immun Assoc	Garland	Texas	United States	75044
127	Live Oak Allergy & Asthma Clinic	San Antonio	Texas	United States	78233
128	Allergy & Asthma Res Ctr PA	San Antonio	Texas	United States	78251
129	Sugar Land Allerg Asthma Immun	Sugar Land	Texas	United States	77479
130	University of Texas Health Center at Tyler	Tyler	Texas	United States	75708
131	Allergy Associates of Utah	Murray	Utah	United States	84107
132	Bridgerland Clinical Research	North Logan	Utah	United States	84341
133	Pulmonary Research of Albingdon	Abingdon	Virginia	United States	24210
134	O & O Alpan, LLC	Fairfax	Virginia	United States	22030
135	Clinical Research Partners, LLC	Henrico	Virginia	United States	23233
136	Allergy Asthma & Sinus Center	Leesburg	Virginia	United States	20176
137	Children's Hospital of the King's Daughter	Norfolk	Virginia	United States	23510
138	Bellingham Asthma, Allergy & Immunology	Bellingham	Washington	United States	98225
139	ASTHMA, Inc	Seattle	Washington	United States	98105
140	Pulmonary & Sleep Research	Spokane	Washington	United States	99204
141	Northwest Asthma Allergy Center	Vancouver	Washington	United States	98664
142	Allergy Asthma & Sinus Center	Greenfield	Wisconsin	United States	53228
143	Dean Clinic	Madison	Wisconsin	United States	53715
144	University of Wisconsin;Allergy & Asthma Clinical Research	Madison	Wisconsin	United States	53792
145	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01922037

Other Study ID Numbers:

ML28528

First Posted:

Aug 14, 2013

Last Update Posted:

Dec 11, 2017

Last Verified:

Nov 1, 2017

Additional relevant MeSH terms:

Asthma

Omalizumab

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail	Results are reported by age group (adult participants and adolescent participants) as well as for all participants.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age greater than or equal to [>/=18] years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Period Title: Overall Study
STARTED	69	737
Treated	69	732
COMPLETED	59	563
NOT COMPLETED	10	174

Baseline Characteristics

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Total of all reporting groups
Overall Participants	69	737	806
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	14.0 (1.69)	50.4 (14.75)	47.3 (17.40)
Sex: Female, Male (Count of Participants)
Female	25 36.2%	487 66.1%	512 63.5%
Male	44 63.8%	250 33.9%	294 36.5%

Outcome Measures

1. Primary Outcome

Title	Total Number of Asthma Exacerbations During Months 1-12
Description	An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.
Time Frame	Months 1-12

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	69	727	796
Mean (Standard Deviation) [asthma exacerbations]	0.46 (0.815)	0.81 (1.407)	0.78 (1.369)

2. Secondary Outcome

Title	Total Number of Asthma Exacerbations During Months 1-6
Description	An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/=3 days.
Time Frame	Months 1-6

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	69	726	795
Mean (Standard Deviation) [asthma exacerbations]	0.20 (0.440)	0.51 (0.988)	0.48 (0.957)

3. Secondary Outcome

Title	Total Number of Asthma Exacerbations During Months 7-12
Description	An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.
Time Frame	Months 7-12

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	63	635	698
Mean (Standard Deviation) [asthma exacerbations]	0.29 (0.521)	0.35 (0.756)	0.35 (0.738)

4. Secondary Outcome

Title	Total Number of Asthma-Related Hospital Admissions During Months 1-12
Description
Time Frame	Months 1-12

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	69	727	796
Mean (Standard Deviation) [asthma-related hospital admissions]	0.04 (0.205)	0.06 (0.356)	0.06 (0.346)

5. Secondary Outcome

Title	Total Number of Asthma-Related Hospital Admissions During Months 1-6
Description
Time Frame	Months 1-6

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	69	726	795
Mean (Standard Deviation) [asthma-related hospital admissions]	0.03 (0.169)	0.03 (0.230)	0.03 (0.225)

6. Secondary Outcome

Title	Total Number of Asthma-Related Hospital Admissions During Months 7-12
Description
Time Frame	Months 7-12

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	63	635	698
Mean (Standard Deviation) [asthma-related hospital admissions]	0.02 (0.126)	0.03 (0.215)	0.03 (0.208)

7. Secondary Outcome

Title	Total Number of Asthma-Related ER Visits During Months 1-12
Description
Time Frame	Months 1-12

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	69	727	796
Mean (Standard Deviation) [asthma-related ER visits]	0.13 (0.380)	0.14 (0.575)	0.14 (0.560)

8. Secondary Outcome

Title	Total Number of Asthma-Related Emergency Room (ER) Visits During Months 1-6
Description
Time Frame	Months 1-6

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	69	726	795
Mean (Standard Deviation) [asthma-related ER visits]	0.04 (0.205)	0.09 (0.410)	0.09 (0.397)

9. Secondary Outcome

Title	Total Number of Asthma-Related ER Visits During Months 7-12
Description
Time Frame	Months 7-12

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	63	635	698
Mean (Standard Deviation) [asthma-related ER visits]	0.10 (0.296)	0.06 (0.293)	0.06 (0.294)

10. Secondary Outcome

Title	Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-12
Description
Time Frame	Months 1-12

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	69	727	796
Mean (Standard Deviation) [asthma-related physician's office visits]	0.39 (0.771)	0.39 (0.866)	0.39 (0.858)

11. Secondary Outcome

Title	Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-6
Description
Time Frame	Months 1-6

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	69	726	795
Mean (Standard Deviation) [asthma-related physician's office visits]	0.23 (0.598)	0.23 (0.584)	0.23 (0.585)

12. Secondary Outcome

Title	Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 7-12
Description
Time Frame	Months 7-12

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	63	635	698
Mean (Standard Deviation) [asthma-related physician's office visits]	0.17 (0.423)	0.18 (0.515)	0.18 (0.507)

13. Secondary Outcome

Title	Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-12
Description
Time Frame	Months 1-12

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	69	727	796
Mean (Standard Deviation) [asthma-related telephone calls]	0.35 (0.783)	0.43 (1.181)	0.43 (1.152)

14. Secondary Outcome

Title	Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-6
Description
Time Frame	Months 1-6

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	69	726	795
Mean (Standard Deviation) [asthma-related telephone calls]	0.16 (0.407)	0.24 (0.799)	0.23 (0.773)

15. Secondary Outcome

Title	Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 7-12
Description
Time Frame	Months 7-12

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	63	635	698
Mean (Standard Deviation) [asthma-related telephone calls]	0.21 (0.544)	0.22 (0.692)	0.22 (0.680)

16. Secondary Outcome

Title	Percentage of Participants by Number of Asthma Exacerbations
Description	Percentage of participants by number of asthma exacerbations (0, 1, 2, 3, >/=4) was reported. An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.
Time Frame	Months 1-12

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	69	727	796
No (0) Asthma Exacerbation	69.6 100.9%	61.8 8.4%	62.4 7.7%
1 Asthma Exacerbation	18.8 27.2%	18.3 2.5%	18.3 2.3%
2 Asthma Exacerbations	7.2 10.4%	9.2 1.2%	9.0 1.1%
3 Asthma Exacerbations	4.3 6.2%	4.3 0.6%	4.3 0.5%
>/=4 Asthma Exacerbations	0 0%	6.5 0.9%	5.9 0.7%

17. Secondary Outcome

Title	Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids
Description	Percentage of participants by number of asthma exacerbations (0, 1, 2, 3, >/=4) requiring treatment with systemic steroids was reported. An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.
Time Frame	Months 1-12

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	69	727	796
No (0) Asthma Exacerbation Requiring Treatment	71.0 102.9%	62.3 8.5%	63.1 7.8%
1 Asthma Exacerbation Requiring Treatment	20.3 29.4%	18.2 2.5%	18.3 2.3%
2 Asthma Exacerbations Requiring Treatment	4.3 6.2%	9.4 1.3%	8.9 1.1%
3 Asthma Exacerbations Requiring Treatment	4.3 6.2%	4.5 0.6%	4.5 0.6%
>/=4 Asthma Exacerbations Requiring Treatment	0 0%	5.6 0.8%	5.2 0.6%

18. Secondary Outcome

Title	Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1)
Description	FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. Pre-bronchodilator FEV1 and post-bronchodilator FEV1 are reported for each timepoint. FEV1 was measured using spirometry.
Time Frame	Baseline, Month 6, end of study (EOS)/early termination (ET) (up to Month 12)

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	67	728	795
Baseline: Pre-bronchodilator FEV1	2.61 (0.736)	2.24 (0.820)	2.27 (0.819)
Change at Month 6: Pre-bronchodilator FEV1	0.09 (0.402)	0.06 (0.359)	0.06 (0.363)
Change at EOS/ET: Pre-bronchodilator FEV1	0.16 (0.463)	0.03 (0.378)	0.04 (0.388)
Baseline: Post-bronchodilator FEV1	2.79 (0.767)	2.38 (0.810)	2.41 (0.814)
Change at Month 6: Post-bronchodilator FEV1	0.05 (0.522)	0.04 (0.286)	0.05 (0.315)
Change at EOS/ET: Post-bronchodilator FEV1	0.18 (0.446)	0.02 (0.322)	0.03 (0.338)

19. Secondary Outcome

Title	Change From Baseline in Raw Forced Vital Capacity (FVC)
Description	FVC was defined as the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pre-bronchodilator FVC and post-bronchodilator FVC are reported for each timepoint. FVC was measured using spirometry.
Time Frame	Baseline, Month 6, EOS/ET (up to Month 12)

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	67	728	795
Baseline: Pre-bronchodilator FVC	3.36 (0.842)	3.08 (0.987)	3.11 (0.978)
Change at Month 6: Pre-bronchodilator FVC	0.09 (0.380)	0.07 (0.562)	0.07 (0.548)
Change at EOS/ET: Pre-bronchodilator FVC	0.22 (0.321)	0.03 (0.417)	0.04 (0.413)
Baseline: Post-bronchodilator FVC	3.43 (0.878)	3.19 (0.959)	3.21 (0.954)
Change at Month 6: Post-bronchodilator FVC	0.06 (0.324)	0.07 (0.661)	0.07 (0.637)
Change at EOS/ET: Post-bronchodilator FVC	0.20 (0.301)	0.02 (0.349)	0.04 (0.348)

20. Secondary Outcome

Title	Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%)
Description	FEF25%-75% was defined as the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. Pre-bronchodilator FEF25%-75% and post-bronchodilator FEF25%-75% are reported for each timepoint. FEF25%-75% was measured using spirometry.
Time Frame	Baseline, Month 6, EOS/ET (up to Month 12)

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	67	727	794
Baseline:Pre-bronchodilator FEF25%-75%	3.96 (12.328)	2.28 (9.646)	2.42 (9.902)
Change at Month 6:Pre-bronchodilator FEF25%-75%	-1.66 (13.518)	-0.44 (10.868)	-0.55 (11.131)
Change at EOS/ET:Pre-bronchodilator FEF25%-75%	-1.69 (13.426)	-0.47 (10.825)	-0.58 (11.080)
Baseline:Post-bronchodilator FEF25%-75%	3.76 (6.676)	2.58 (9.503)	2.68 (9.302)
Change at Month 6:Post-bronchodilator FEF25%-75%	-1.00 (7.513)	-0.59 (11.051)	-0.63 (10.767)
Change at EOS/ET:Post-bronchodilator FEF25%-75%	-0.76 (7.515)	-0.61 (10.926)	-0.62 (10.661)

21. Secondary Outcome

Title	Change From Baseline in Percentage Predicted FEV1 (ppFEV1)
Description	FEV1 is the volume of air that can be forced out in one second after taking a deep breath, as measured using spirometry. Hankinson and Wang standards were used to calculate ppFEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. ppFEV1= 100 multiplied by (*) FEV1 (in liters [L]) divided by (/) predicted FEV1 (in L). Pre-bronchodilator ppFEV1 and post-bronchodilator ppFEV1 are reported for each timepoint.
Time Frame	Baseline, Month 6, EOS/ET (up to Month 12)

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	67	728	795
Baseline: Pre-bronchodilator ppFEV1	87.89 (16.934)	74.23 (20.569)	75.38 (20.631)
Change at Month 6: Pre-bronchodilator ppFEV1	2.72 (13.279)	1.77 (12.270)	1.86 (12.359)
Change at EOS/ET: Pre-bronchodilator ppFEV1	6.00 (14.713)	0.91 (12.922)	1.37 (13.163)
Baseline: Post-bronchodilator ppFEV1	93.61 (16.416)	78.92 (19.514)	80.15 (19.690)
Change at Month 6: Post-bronchodilator ppFEV1	2.09 (16.398)	1.47 (9.617)	1.52 (10.421)
Change at EOS/ET: Post-bronchodilator ppFEV1	7.39 (14.673)	0.82 (11.099)	1.40 (11.597)

22. Secondary Outcome

Title	Percentage of Participants With Prior Asthma Medications by Category or Class of Medications
Description	Prior asthma medications were defined as all medications used for asthma prior to the study (initiated within 90 days of baseline) and were assessed retrospectively at baseline. Participants received prior asthma medications of following categories or classes: short acting beta agonist (SABA), combination inhaled corticosteroids/long acting beta agonist (ICS/LABA), leukotriene receptor antagonist (LTRA), inhaled corticosteroids (ICS), oral/parenteral (systemic) corticosteroids, anticholinergic, long acting beta agonist (LABA), and other medication.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description
All enrolled participants.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	69	737	806
All types	98.6 142.9%	99.3 13.5%	99.3 12.3%
SABA	91.3 132.3%	88.6 12%	88.8 11%
Combination ICS/LABA	79.7 115.5%	84.1 11.4%	83.7 10.4%
LTRA	73.9 107.1%	66.6 9%	67.2 8.3%
ICS	36.2 52.5%	33.8 4.6%	34.0 4.2%
Oral/Parenteral (systemic) corticisteroids	27.5 39.9%	31.6 4.3%	31.3 3.9%
Anticholinergic	10.1 14.6%	28.4 3.9%	26.8 3.3%
LABA	1.4 2%	4.1 0.6%	3.8 0.5%
Other medication	5.8 8.4%	5.3 0.7%	5.3 0.7%

23. Secondary Outcome

Title	Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications
Description	Concomitant and ongoing asthma medications were defined as all medications used for asthma which began on or after the participant's study start, as well as those ongoing at the beginning of the study. Participants received following categories or classes of concomitant and ongoing asthma medications: SABA, combination ICS/LABA, LTRA, oral/parenteral (systemic) corticosteroids, ICS, anticholinergic, LABA, and other medication.
Time Frame	Baseline until EOS/ET (up to Month 12)

Outcome Measure Data

Analysis Population Description
All enrolled participants.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	69	737	806
All types	100.0 144.9%	99.2 13.5%	99.3 12.3%
SABA	91.3 132.3%	89.4 12.1%	89.6 11.1%
Combination ICS/LABA	82.6 119.7%	82.4 11.2%	82.4 10.2%
LTRA	69.6 100.9%	63.9 8.7%	64.4 8%
Oral/Parenteral (systemic) corticosteroids	37.7 54.6%	47.2 6.4%	46.4 5.8%
ICS	33.3 48.3%	34.3 4.7%	34.2 4.2%
Anticholinergic	11.6 16.8%	32.6 4.4%	30.8 3.8%
LABA	1.4 2%	4.5 0.6%	4.2 0.5%
Other medication	7.2 10.4%	9.9 1.3%	9.7 1.2%

24. Secondary Outcome

Title	Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score
Description	AQLQ +12 is a 32-item disease specific questionnaire designed to assess the participants' asthma-specific health-related quality of life (QOL). The questionnaire contains four domains: activity limitations (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). All items are scored on a 7-point likert scale. All item scores are averaged to produce one overall QOL score. Overall score ranges from 1 (total impairment) to 7 (no impairment), with higher scores indicating better QOL. A positive change from baseline indicated improved QOL.
Time Frame	Baseline, Month 6, EOS/ET (up to Month 12)

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	69	732	801
Baseline	4.71 (1.332)	3.93 (1.348)	4.00 (1.363)
Change at Month 6	0.94 (1.134)	1.18 (1.223)	1.16 (1.216)
Change at EOS/ET	1.11 (1.174)	1.33 (1.267)	1.31 (1.259)

25. Secondary Outcome

Title	Change From Baseline in Asthma Control Test (ACT) Overall Score
Description	Multidimensional factors associated with asthma control from the participant's perspective were assessed using the ACT questionnaire. The ACT is a validated, five-item patient-reported outcome (PRO) questionnaire that measures the impact of asthma on home and work activities, shortness of breath, symptoms, rescue medication usage, and overall asthma control. All items are scored on a 5-point likert scale (1 to 5). All item scores are added together to calculate a total score. Total score ranges from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. A positive change from baseline indicated improvement.
Time Frame	Baseline, Months 3, 6, 9, 12

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	68	732	800
Baseline	16.40 (5.117)	13.71 (4.910)	13.94 (4.981)
Change at Month 3	3.11 (4.141)	3.58 (4.263)	3.54 (4.252)
Change at Month 6	3.57 (4.339)	4.16 (4.677)	4.11 (4.649)
Change at Month 9	3.90 (4.844)	4.39 (4.910)	4.35 (4.903)
Change at Month 12	3.90 (4.997)	4.48 (4.926)	4.43 (4.932)

26. Secondary Outcome

Title	Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score
Description	WPAI-asthma is a self-administered instrument to measure asthma-specific performance impairment of work and regular daily activity within the last 7 days and yields 4 types of scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (WI) (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). Total score and each score ranged from 0 (not affected/no impairment) to 100 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. A negative change in score indicated improvement and a positive change indicated impairment.
Time Frame	Baseline, Month 6, EOS/ET (up to Month 12)

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	67	717	784
Work time missed: Baseline	10.37 (14.759)	7.70 (19.936)	7.72 (19.890)
Work time missed: Change at Month 6	0.00	-3.31 (19.796)	-3.30 (19.763)
Work time missed: Change at EOS/ET	-27.27	-4.06 (21.977)	-4.14 (21.982)
Impairment while working: Baseline	10.00 (14.142)	31.36 (27.111)	31.15 (27.087)
Impairment while working: Change at Month 6	0.00 (0.000)	-16.24 (26.775)	-16.13 (26.719)
Impairment while working: Change at EOS/ET	-30.00	-15.93 (27.677)	-15.98 (27.643)
Overall WI: Baseline	20.85 (25.366)	33.59 (28.737)	33.49 (28.705)
Overall WI: Change at Month 6	0.00	-15.55 (27.476)	-15.49 (27.443)
Overall WI: Change at EOS/ET	-49.09	-16.24 (29.578)	-16.35 (29.590)
Activity impairment: Baseline	36.12 (27.577)	48.79 (28.749)	47.70 (28.893)
Activity impairment: Change at Month 6	-9.12 (33.449)	-19.30 (30.445)	-18.38 (30.840)
Activity impairment: Change at EOS/ET	-14.83 (31.967)	-21.40 (32.424)	-20.80 (32.413)

27. Secondary Outcome

Title	Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using Global Evaluation of Treatment Effectiveness (GETE) by Inversigator
Description	Response to treatment was assessed using the GETE. The GETE is a validated instrument that measures the overall impression of the effect of the study medication on typical asthma symptoms. The evaluation was performed using the 5-point scale. The GETE scale ranges were as follows: 1=excellent, 2=good, 3=moderate, 4=poor, 5= worsening. A good or excellent response on the 5 point scale indicated that a participant had responded to treatment. Percentage of participants who showed an improvement (GETE scale score of 1 or 2) in asthma symptoms, as assessed by investigator, is reported.
Time Frame	EOS/ET (up to Month 12)

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	63	583	646
Number [percentage of participants]	81.0 117.4%	75.8 10.3%	76.3 9.5%

28. Secondary Outcome

Title	Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using GETE by Participant
Description	Response to treatment was assessed using the GETE. The GETE is a validated instrument that measures the overall impression of the effect of the study medication on typical asthma symptoms. The evaluation was performed using the 5-point scale. The GETE scale ranges were as follows: 1=excellent, 2=good, 3=moderate, 4=poor, 5= worsening. A good or excellent response on the 5 point scale indicated that a participant had responded to treatment. Percentage of participants who showed an improvement (GETE scale score of 1 or 2) in asthma symptoms, as assessed by participant, is reported.
Time Frame	EOS/ET (up to Month 12)

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	63	599	662
Number [percentage of participants]	87.3 126.5%	75.0 10.2%	76.1 9.4%

29. Secondary Outcome

Title	Change From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Quality of Life Score
Description	The MiniRQLQ is a shorter version of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) instrument. The MiniRQLQ is a validated quality of life questionnaire to measure the functional impairments that are most troublesome to adult participants with either seasonal or perennial rhinoconjunctivitis of either allergic or non-allergic origin. The miniRQLQ contains 14 items; each item scored on a 7-point scale ranging from 0 [not impaired at all] to 6 [severely impaired]). The overall quality of life score is the average of the all item scores and ranges from 0 (not impaired at all) to 6 (severely impaired), with higher scores indicating more impairment. A negative change in score indicated improvement and a positive change indicated impairment.
Time Frame	Baseline, EOS/ET (up to Month 12)

Outcome Measure Data

Analysis Population Description
All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)	Participants With Allergic Asthma (Age >/=18 Years)	Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.	All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
Measure Participants	68	732	800
Baseline	2.44 (1.435)	2.76 (1.375)	2.73 (1.382)
Change at EOS/ET	-1.17 (1.357)	-0.99 (1.307)	-1.01 (1.311)

Adverse Events

	Participants With Allergic Asthma (Age 12-17 Years)		Participants With Allergic Asthma (Age >/=18 Years)		Total Participants With Allergic Asthma
Time Frame	From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year)
Adverse Event Reporting Description	Safety evaluable participants defined as those who received at least 1 dose of omalizumab at any point in the study. Safety events collected and recorded during the study were: all serious adverse events, nonserious AEs of special interest, pregnancies, and nonserious AEs causally related to a Genentech product or where causality is unknown. Additional AEs not meeting the protocol-specified criteria listed above were reported during the study and were included in the safety database.

Arm/Group Title	Participants With Allergic Asthma (Age 12-17 Years)		Participants With Allergic Asthma (Age >/=18 Years)		Total Participants With Allergic Asthma
Arm/Group Description	Adolescent participants (age 12-17 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.		Adult participants (age >/=18 years) with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.		All participants with allergic asthma, who had decided to initiate treatment with omalizumab were observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurred first.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Participants With Allergic Asthma (Age 12-17 Years)		Participants With Allergic Asthma (Age >/=18 Years)		Total Participants With Allergic Asthma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/69 (7.2%)		85/732 (11.6%)		90/801 (11.2%)
Cardiac disorders
Acute left ventricular failure	0/69 (0%)		2/732 (0.3%)		2/801 (0.2%)
Myocardial infarction	0/69 (0%)		2/732 (0.3%)		2/801 (0.2%)
Angina pectoris	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Arrhythmia	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Atrial fibrillation	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Cardiac arrest	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Cardiogenic shock	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Coronary artery thrombosis	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Ventricular fibrillation	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Gastrointestinal disorders
Abdominal pain	0/69 (0%)		2/732 (0.3%)		2/801 (0.2%)
Gastrooesophageal reflux disease	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Pancreatitis	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Pancreatitis acute	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
General disorders
Chest pain	0/69 (0%)		2/732 (0.3%)		2/801 (0.2%)
Hepatobiliary disorders
Cholelithiasis	0/69 (0%)		2/732 (0.3%)		2/801 (0.2%)
Immune system disorders
Anaphylactic reaction	0/69 (0%)		2/732 (0.3%)		2/801 (0.2%)
Allergic granulomatous angiitis	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Infections and infestations
Pneumonia	0/69 (0%)		11/732 (1.5%)		11/801 (1.4%)
Cellulitis	0/69 (0%)		2/732 (0.3%)		2/801 (0.2%)
Diverticulitis	0/69 (0%)		2/732 (0.3%)		2/801 (0.2%)
Influenza	1/69 (1.4%)		1/732 (0.1%)		2/801 (0.2%)
Appendicitis	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Bacteraemia	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Gastrointestinal viral infection	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Osteomyelitis	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Tubo-ovarian abscess	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Urinary tract infection	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Injury, poisoning and procedural complications
Fall	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Rib fracture	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Road traffic accident	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Wound	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Investigations
Helicobacter test positive	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Metabolism and nutrition disorders
Dehydration	0/69 (0%)		2/732 (0.3%)		2/801 (0.2%)
Fluid retention	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Type 2 diabetes mellitus	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Musculoskeletal and connective tissue disorders
Back pain	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Intervertebral disc displacement	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Osteoporotic fracture	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Malignant glioma	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Non-Hodgkin's lymphoma	1/69 (1.4%)		0/732 (0%)		1/801 (0.1%)
Ovarian epithelial cancer	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Prostate cancer	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Renal cell carcinoma	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Nervous system disorders
Cerebellar haemorrhage	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Headache	1/69 (1.4%)		0/732 (0%)		1/801 (0.1%)
Hemiparesis	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Intracranial aneurysm	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Migraine	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	0/69 (0%)		2/732 (0.3%)		2/801 (0.2%)
Psychiatric disorders
Depression	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Suicidal ideation	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Renal and urinary disorders
Nephrolithiasis	0/69 (0%)		2/732 (0.3%)		2/801 (0.2%)
Reproductive system and breast disorders
Pelvic adhesions	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Respiratory, thoracic and mediastinal disorders
Asthma	3/69 (4.3%)		23/732 (3.1%)		26/801 (3.2%)
Chronic obstructive pulmonary disease	0/69 (0%)		4/732 (0.5%)		4/801 (0.5%)
Pulmonary embolism	0/69 (0%)		3/732 (0.4%)		3/801 (0.4%)
Status asthmaticus	0/69 (0%)		3/732 (0.4%)		3/801 (0.4%)
Dyspnoea	0/69 (0%)		2/732 (0.3%)		2/801 (0.2%)
Nasal polyps	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Pleural effusion	1/69 (1.4%)		0/732 (0%)		1/801 (0.1%)
Pneumonia aspiration	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Pneumothorax	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Skin and subcutaneous tissue disorders
Angioedema	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Surgical and medical procedures
Mastectomy	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Muscle operation	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Vascular disorders
Deep vein thrombosis	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Embolism	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Hypotension	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Orthostatic hypotension	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Peripheral embolism	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Other (Not Including Serious) Adverse Events
	Participants With Allergic Asthma (Age 12-17 Years)		Participants With Allergic Asthma (Age >/=18 Years)		Total Participants With Allergic Asthma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/69 (13%)		58/732 (7.9%)		67/801 (8.4%)
Endocrine disorders
Hypothyroidism	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Gastrointestinal disorders
Diarrhoea	1/69 (1.4%)		0/732 (0%)		1/801 (0.1%)
Paraesthesia oral	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Vomiting	1/69 (1.4%)		0/732 (0%)		1/801 (0.1%)
General disorders
Chest discomfort	0/69 (0%)		2/732 (0.3%)		2/801 (0.2%)
Injection site reaction	0/69 (0%)		2/732 (0.3%)		2/801 (0.2%)
Fatigue	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Influenza like illness	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Injection site pain	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Injection site pruritus	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Injection site swelling	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Local reaction	1/69 (1.4%)		0/732 (0%)		1/801 (0.1%)
Pain	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Hepatobiliary disorders
Cholecystitis	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Immune system disorders
Serum sickness	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Anaphylactic reaction	0/69 (0%)		3/732 (0.4%)		3/801 (0.4%)
Infections and infestations
Bronchitis	0/69 (0%)		2/732 (0.3%)		2/801 (0.2%)
Pneumonia	0/69 (0%)		2/732 (0.3%)		2/801 (0.2%)
Acute sinusitis	1/69 (1.4%)		0/732 (0%)		1/801 (0.1%)
Influenza	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Mononucleosis syndrome	1/69 (1.4%)		0/732 (0%)		1/801 (0.1%)
Pneumonia mycoplasmal	1/69 (1.4%)		0/732 (0%)		1/801 (0.1%)
Upper respiratory tract infection	1/69 (1.4%)		0/732 (0%)		1/801 (0.1%)
Urinary tract infection	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Injury, poisoning and procedural complications
Fall	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Laceration	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Pelvic fracture	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Metabolism and nutrition disorders
Hyperlipidaemia	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Hypertriglyceridaemia	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Type 2 diabetes mellitus	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Bone pain	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Muscle spasms	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Muscular weakness	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Myalgia	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer metastatic	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Nervous system disorders
Dizziness	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Headache	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Reproductive system and breast disorders
Benign prostatic hyperplasia	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Respiratory, thoracic and mediastinal disorders
Asthma	3/69 (4.3%)		6/732 (0.8%)		9/801 (1.1%)
Wheezing	1/69 (1.4%)		1/732 (0.1%)		2/801 (0.2%)
Bronchial secretion retention	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Dysphonia	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Dyspnoea	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Nasal polyps	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Pneumothorax spontaneous	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Respiratory tract congestion	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Sputum increased	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Skin and subcutaneous tissue disorders
Urticaria	0/69 (0%)		3/732 (0.4%)		3/801 (0.4%)
Pruritus	0/69 (0%)		2/732 (0.3%)		2/801 (0.2%)
Acne	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Rash erythematous	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Rash pruritic	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Urticaria chronic	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Surgical and medical procedures
Foot operation	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Hernia hiatus repair	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Hip arthroplasty	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Meningioma surgery	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Rotator cuff repair	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Skin graft	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)
Vascular disorders
Flushing	0/69 (0%)		1/732 (0.1%)		1/801 (0.1%)

Limitations/Caveats

This study was designed as an observational registry of participants with allergic asthma; but, was later reclassified as an interventional trial because the protocol was amended to include blood draws that were not considered to be standard of care.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Results Point of Contact

Name/Title	Medical Communications
Organization	Hoffmann-La Roche
Phone	800-821-8590
Email	genentech@druginfo.com

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01922037

Other Study ID Numbers:

ML28528

First Posted:

Aug 14, 2013

Last Update Posted:

Dec 11, 2017

Last Verified:

Nov 1, 2017

A Study in Participants With Asthma Initiating Treatment With Omalizumab (Xolair)

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