Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02537691
• Collaborator: (none)
• Enrollment: 483
• Locations: 100
• Arm: 1
• Actual Duration (Months): 22.4
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Prospective, single-arm, longitudinal, international, multicenter study in a real-world cohort of adult severe asthma participants being conducted to assess the relationships between asthma biomarkers and asthma-related health-outcomes for a period of 52 weeks.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: FP; Drug: LABA; Drug: LTRA; Drug: LAMA; Drug: Theophylline; Drug: Oral Corticosteroids	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 483 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: A Prospective, Single Arm, Longitudinal Cohort Study To Assess Biomarkers In Real World Patients With Severe Asthma
• Actual Study Start Date: Aug 28, 2015
• Actual Primary Completion Date: Jul 10, 2017
• Actual Study Completion Date: Jul 10, 2017

Arms and Interventions

Arm

Intervention/Treatment

Other: Inhaled Corticosteroids (ICS) + Controller Medications Participants with severe asthma Global Initiative for Asthma (GINA) step 4/5 as indicated by current treatment with daily ICS consisting of >/=500 mcg FP administered by DPI (or equivalent), and at least one of the following controller medications: LABAs, LTRAs, LAMAs, theophylline or oral corticosteroids.

Drug: FP; ICS consisting of FP will be administered by DPI (or equivalent) as per investigator discretion.; Drug: LABA; LABA will be administered as per investigator discretion.; Drug: LTRA; LTRA will be administered as per investigator discretion.; Drug: LAMA; LAMA will be administered as per investigator discretion.; Drug: Theophylline; Theophylline will be administered as per investigator discretion.; Drug: Oral Corticosteroids; Oral corticosteroids will be administered as per investigator discretion.

Outcome Measures

Primary Outcome Measures

1. Mean Number of Asthma Exacerbations in Participants With High Baseline Periostin Compared to participants With Low Baseline Periostin [Baseline up to Week 52]

Secondary Outcome Measures

1. Percentage of Participants With Asthma Exacerbations [Baseline up to Week 52]

2. Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Specified Time Points [Baseline, Weeks 26, 52]

3. Time Taken for the Occurrence of First Asthma Exacerbation [Baseline up to Week 52]

4. Time to Treatment Failure [Baseline up to Week 52]

5. Change From Baseline in Mini Standardized Asthma Quality of Life Questionnaire (MiniAQLQ) at Specified Time Points [Baseline, Weeks 13, 26, 39, 52]

6. Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) at Specified Time Points [Baseline, Weeks 13, 26, 39, 52 or within 12 weeks of last visit for early termination (up to Week 52)]

7. Change From Baseline in Asthma Control Test (ACT) at Specified Time Points [Baseline, Weeks 13, 26, 39, 52 or within 12 weeks of last visit for early termination (up to Week 52)]

8. Percentage of Participants With Changes to Standard of Care (SoC) Asthma Treatment as Reported by the Investigator and Confirmed by Study Steering Committee [Baseline up to Week 52]

9. Serum Periostin Levels During the Study [Baseline, Weeks 26, 52]

10. Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels [Baseline, Weeks 26, 52]

11. Blood Eosinophil Levels During the Study [Baseline, Weeks 26, 52]

12. Serum Immunoglobulin E (IgE) Levels During the Study [Baseline, Weeks 26, 52]

13. Number of Urgent Asthma-Related Health Care Utilization: Hospitalizations [Weeks 13, 26, 39, 52]

14. Number of Urgent Asthma-Related Health Care Utilization: Emergency Department Visits [Weeks 13, 26, 39, 52]

15. Number of Urgent Asthma-Related Health Care Utilization: Acute Care Visits [Weeks 13, 26, 39, 52]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Asthma diagnosed by a respiratory physician greater than or equal to (>/=) 12 months prior to study enrolment

• Pre-bronchodilator FEV1 of 30 percent (%) to 85% at baseline/Visit 1

• Documented bronchodilator response defined as >/=12% relative improvement in FEV1 after bronchodilator administration or a positive methacholine bronchial challenge test with provocative concentration causing a 20% fall in FEV1 (PC20) less than (<) 8 milligrams (mg) at study baseline/Visit 1 or within 24 months prior to baseline

• Current treatment with a total daily dose of >/= 500 micrograms (mcg) of fluticasone propionate (FP) dry powder inhaler (DPI) (or equivalent ) and at least one of the following controller medications: long-acting Beta-agonist (LABA), leukotriene receptor antagonist (LTRA), long-acting muscarinic antagonists (LAMAs), theophylline or oral corticosteroids, with a continued duration of three months prior to baseline/Visit 1

Exclusion Criteria:

• Acute or chronic parasitic, bacterial, fungal or viral infections that required, or currently require, hospitalization or antimicrobial treatment during the last four weeks prior to participant eligibility

• Acute asthma exacerbation or any other medical event treated with increased doses of oral, or any dose of intramuscular (IM) or intravenous (IV) corticosteroids within six weeks prior to study

• Other relevant pulmonary diseases (e.g. chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, pulmonary arterial hypertension, tuberculosis) requiring treatment within 12 months prior to baseline/Visit 1

• Ex-smokers with >/=10 pack-year smoking history

• Prior treatment with bronchial thermoplasty

• Participation in any clinical trial of an investigational agent or procedure within six months prior to baseline/Visit 1 or during the study

• Pregnancy prior to participation or during the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Center of Alabama, LLC	Birmingham	Alabama	United States	35209
2	Southern California Research Center	Mission Viejo	California	United States	92691
3	Capital Allergy Resp Dis Ctr	Sacramento	California	United States	95819
4	Allergy Assoc Medical Group	San Diego	California	United States	92108
5	Yale New Haven Hospital	New Haven	Connecticut	United States	06520
6	Waterbury Pulmonary Associates	Waterbury	Connecticut	United States	06708
7	AAADRS; Clinical Research Center	Coral Gables	Florida	United States	33134
8	Volunteer Medical Research	Port Charlotte	Florida	United States	33952
9	University of South Florida	Tampa	Florida	United States	33613
10	Georgia Pollens Clinical Research Centers	Albany	Georgia	United States	31707
11	Asthma & Allergy Center, P.C.	Papillion	Nebraska	United States	68046
12	Allergy & Asthma Research of Nj, Inc	Mount Laurel	New Jersey	United States	08054
13	Montefiore Medical Center	Bronx	New York	United States	10461
14	Island Medical Research Pc	Commack	New York	United States	11725
15	Winthrop University Hospital	Mineola	New York	United States	11501
16	Laura and ISAAC Perlmutter Cancer Center at NYU Langone.	New York	New York	United States	10016
17	Vital Prospects Clin Res Pc	Tulsa	Oklahoma	United States	74136
18	Allergy-Asthma Specialists PC	Blue Bell	Pennsylvania	United States	19422
19	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033
20	Allergy & Clinical Immun Assoc	Pittsburgh	Pennsylvania	United States	15241
21	Berks-Schuylkill Respiratory Specialists, Ltd	Wyomissing	Pennsylvania	United States	19610
22	Baylor College of Medicine	Houston	Texas	United States	77030
23	Allergy & Asthma Res Ctr PA	San Antonio	Texas	United States	78251
24	Allergy Associates of Utah	Murray	Utah	United States	84107
25	Bridgerland Clinical Research	North Logan	Utah	United States	84341
26	Northridge Internal Medicine	Charlottesville	Virginia	United States	22903
27	O & O Alpan, LLC	Fairfax	Virginia	United States	22030
28	ASTHMA, Inc	Seattle	Washington	United States	98105
29	Pulmonary & Sleep Research	Spokane	Washington	United States	99204
30	Hospital Erasme; Neurologie	Bruxelles		Belgium	1070
31	Private Practice	Jambes		Belgium	5100
32	UZ Leuven Gasthuisberg	Leuven		Belgium	3000
33	CHU Sart-Tilman	Liège		Belgium	4000
34	CHU UCL Mont-Godinne	Mont-godinne		Belgium	5530
35	Mhat - Pleven; Clinic of Pulmonology	Pleven		Bulgaria	5800
36	Specialized Hospital for Active Treatment for pneumo-phtysiatric diseases	Ruse		Bulgaria	7002
37	Vancouver General Hosp; The Lung Centre	Vancouver	British Columbia	Canada	V5Z 1L7
38	St. Paul's Hospital University of British Colambia Division of Hematology	Vancouver	British Columbia	Canada	V6Z 1Y6
39	Burlington Lung Clinic	Burlington	Ontario	Canada	L7N 3V2
40	Kingston General Hospital	Kingston	Ontario	Canada	K7L 2V6
41	Inspiration Research Limited	Toronto	Ontario	Canada	M5T 3A9
42	Centre Hospitalier de l'Université de Montréal (CHUM)	Montreal	Quebec	Canada	H2X 3E4
43	Jewish General Hospital; Endoscopy Department	Montreal	Quebec	Canada	H3T 1E2
44	Hopital Laval; Centre de Pneumologie	Quebec		Canada	G1V 4G5
45	Hvidovre Hospital, Lungemedicinsk Afdeling	Hvidovre		Denmark	2650
46	Lungemedicinsk afd. L, Bispebjerg Hospital	København NV		Denmark	2400
47	Hopital Bichat Claude Bernard ; Service de Pneumologie	Paris		France	75877
48	Institut für Allergie- und Asthmaforschung Berlin, IAAB	Berlin		Germany	12159
49	Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH	Bochum		Germany	44789
50	Lungenzentrum Darmstadt	Darmstadt		Germany	64283
51	Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie	Essen		Germany	45239
52	Universitätsklinikum Freiburg, Abteilung Pneumologie	Freiburg		Germany	79106
53	Pneumologicum	Hannover		Germany	30173
54	KPPK Studienzentrum GmbH; Dr. med. A. Kroker, Dr. med. O. Schmidt	Koblenz		Germany	56068
55	Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie	Mainz		Germany	55131
56	Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V	München		Germany	81377
57	Dr. Kenessey Albert Korhaz Es Rendelointezet; Tudoosztaly (Pulmonolgy Dept )	Balassagyarmat		Hungary	2660
58	Synexus Magyarorszag Kft	Budapest		Hungary	1036
59	Szent János Kórház; Tüdőgondozó Intézet és Szűrőállomás	Budapest		Hungary	1122
60	Debrecen Uni Medical School; Dept of Pulmonary Medicine	Debrecen		Hungary	4032
61	Matrai Állami Gyógyintézet ; Bronchológia	Mátraháza		Hungary	3233
62	Presidio Ospedaliero SS. Annunziata di Chieti ; Dip. Medico-UOSD Allergologia	Chieti	Abruzzo	Italy	66100
63	Policlinico di Modena; Oncologia, Ematologia e Patologie dell'apparato Respiratorio	Modena	Emilia-Romagna	Italy	41124
64	IRCCS AOU SAN MARTINO - IST;UO ALLERGOLOGIA-IMMUNOPATOLOGIA RESPIRATORIA e TERAPIE BIOTECNOLOGICHE	Genova	Liguria	Italy	16132
65	AOU Città della Salute e della Scienza di Torino - Ospedale Le Molinette; SC Pneumologia	Torino	Piemonte	Italy	10126
66	Azienda Policlinico Vittorio Emanuele; Pneumologia Riabilitativa E Allergologia	Catania	Sicilia	Italy	95123
67	A.O. Ospedali Riuniti; Villa Sofia-Cervello di Palermo; U. O. Pneumologia 2 - Padiglione B	Palermo	Sicilia	Italy	90146
68	A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii	Pisa	Toscana	Italy	56124
69	Clinical Hospital Gailezers; Dept of Pulmonology	Riga		Latvia	1038
70	Riga 1st hospital, outpatient clinic Bruninieks	Riga		Latvia	LV-1001
71	Latvian University postgraduate institute	Riga		Latvia	LV-1011
72	Spaarne Ziekenhuis Hoofddorp; Long Geneeskunde	Hoofddorp		Netherlands	2134 TM
73	Medisch Centrum Leeuwarden; Longziekten	Leeuwarden		Netherlands	8934 AD
74	St. Antonius; R&D Long	Nieuwegein		Netherlands	3435 CM
75	CHVNG/E_Unidade 1; Servico de Pneumologia	Vila Nova De Gaia		Portugal	4434-502
76	Research Institute of Complex Cardiovascular Pathology	Kemerovo		Russian Federation	650002
77	SBIH "Clinical dermatovenerologic dispensary " of Ministry of Health of the Krasnodar region	Krasnodar		Russian Federation
78	FSBI "National Research Center - Institute of Immunology" of FMBA of Russia	Moscow		Russian Federation	115478
79	SBEI APE Russian Medical Academy of Post-graduate Education; Department of Clinical Allergology	Moscow		Russian Federation	125993
80	SBHI of NN region "RCH of NN n.a. N.A.Semashko"	Nizhny Novgorod		Russian Federation	603126
81	City Out-patient Clinic #106	Saint-Petersburg		Russian Federation	198328
82	Saratov State Medical University; Chair Of Clinical Allergology	Saratov		Russian Federation	410012
83	City Hospital #40 of Resort Administrative District	St. Petersburg		Russian Federation	197706
84	SBEI HPE "North Ossetian State Medical Academy" of Ministry of Health of Russia	Vladikavkaz		Russian Federation
85	Complexo Hospitalario Universitario de Santiago	Santiago de Compostela	LA Coruña	Spain	15706
86	Hospital Universitario Puerta de Hierro Majadahonda; Servicio de Neumología	Majadahonda	Madrid	Spain	28222
87	Hospital de Galdakano; Servicio de Neumologia	Galdakano	Vizcaya	Spain	48960
88	Fundacio Santa Creu I Sant Pau	Barcelona		Spain	08006
89	Hospital Clinic I provincial; Servicio de Neumologia	Barcelona		Spain	08036
90	Hospital Universitario Reina Sofia; Servicio de Neumología	Cordoba		Spain
91	Hospital Universitario 12 de Octubre; Servicio de Neumologia	Madrid		Spain	28041
92	Queen Elizabeth Hospital	Birmingham		United Kingdom	B15 2TH
93	Bradford Royal Infirmary	Bradford		United Kingdom	BD9 6RJ
94	Gloucestershire Royal Hospital	Gloucester		United Kingdom	GL1 3NN
95	William Harvey Research Institute	London		United Kingdom	EC1M 6BQ
96	St George's Hospital	London		United Kingdom	SW17 0QT
97	North Manchester Hospital; Respiratory Department	Manchester		United Kingdom	M8 5RB
98	Freeman Hospital; Respiratory Department; Sir William Leach Lung Research Centre	Newcastle upon Tyne		United Kingdom	NE7 7DN
99	Queen Alexandra Hospital, Portsmouth	Portsmouth		United Kingdom	PO6 3LY
100	Royal Shrewsbury Hospital	Shrewsbury		United Kingdom	SY3 8XQ

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: NCT02537691
• Other Study ID Numbers: MB29599; 2015-000742-35
• First Posted: Sep 2, 2015
• Last Update Posted: Apr 9, 2019
• Last Verified: Apr 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Asthma; Theophylline

Study Results

No Results Posted as of Apr 9, 2019