Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03226392
• Collaborator: (none)
• Enrollment: 704
• Locations: 142
• Arms: 2
• Actual Duration (Months): 21
• Patients Per Site: 5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

A randomized, multicenter, double-blind, placebo- controlled parallel-group study to determine the efficacy and safety of QAW039, compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1 second (FEV1) at the end of 12 weeks of treatment.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: QAW039; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 704 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma
• Actual Study Start Date: Oct 31, 2017
• Actual Primary Completion Date: Jul 5, 2019
• Actual Study Completion Date: Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: QAW039 QAW039 once daily	Drug: QAW039; QAW039 once daily
Placebo Comparator: Placebo Placebo once daily	Drug: Placebo; Placebo once daily

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Pre-dose FEV1 [Baseline and Week 12]

   Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.

Secondary Outcome Measures

1. Change From Baseline in Daytime Asthma Symptom Score [Baseline and Week 12]

   Daytime asthma symptoms are evaluated through four questions and each of them will be rated on a scale of 0 to 6. Higher scores indicate more severe asthma-related symptoms. A mean score is calculated for the responses to 4 questions.

2. Change From Baseline in Number of Puffs of SABA Taken Per Day [Baseline (daily mean for up to three weeks prior to baseline visit) and Week 12 (daily mean post baseline up to Week 12)]

   Daily use of SABA (the number of rescue medication puffs taken in the previous 12 hours) was recorded using a patient electronic diary (referred to as eDiary or eDiary/ePEF). Patients were instructed to routinely complete the patient diary twice daily - at the same time each morning and each evening, approximately 12 hours apart.

3. Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ+12) Score [Baseline and Week 12]

   AQLQ is a 32-item instrument administered as a self-assessment. AQLQ+12 is a modified version of AQLQ developed to measure functional impairments of participants aged 12-70 years. It is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Participants were asked to recall their experiences during the last 2 weeks and respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated "better quality of life." Overall AQLQ+12 score is the mean of all 32 responses.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• A diagnosis of asthma (according to GINA 2016) for a period of at least 6 months.

• Treated with medium dose inhaled corticosteroid (ICS), or high dose ICS, or low dose ICS plus long- acting beta agonist (LABA), or low dose ICS plus leukotriene receptor antagonist (LTRA), or medium dose ICS plus LABA for at least 3 months prior to Visit 1 and the doses have been stable for at least 4 weeks prior to Visit 1.

• FEV1 of ≤85% for patients aged ≥18 years. FEV1 of ≤90% for patients aged 12 to <18 years.

• Daytime asthma symptom score (0 to 6 scale) of ≥1 per day during 4 of the last 7 days of the placebo run- in period.

• Total daily SABA use ≥1 puff per day during 4 of the last 7 days of the placebo run-in period.

• Demonstrated reversible airway obstruction.

• Asthma control questionnaire (ACQ) score ≥ 1.5.

Exclusion Criteria:

• Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.

• A resting QTcF (Fridericia) ≥450 msec (male) or

≥460 msec (female).

• Pregnant or nursing (lactating) women.

• Serious co-morbidities.

• Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or

2 mg of pitavastatin.

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Andalusia	Alabama	United States	36420
2	Novartis Investigative Site	Birmingham	Alabama	United States	35209
3	Novartis Investigative Site	Tucson	Arizona	United States	85745
4	Novartis Investigative Site	Los Angeles	California	United States	90048
5	Novartis Investigative Site	Newport Beach	California	United States	92663
6	Novartis Investigative Site	Rolling Hills Estates	California	United States	90274
7	Novartis Investigative Site	San Diego	California	United States	92117
8	Novartis Investigative Site	San Diego	California	United States	92120
9	Novartis Investigative Site	San Jose	California	United States	95117
10	Novartis Investigative Site	Stockton	California	United States	95207
11	Novartis Investigative Site	Colorado Springs	Colorado	United States	80907
12	Novartis Investigative Site	Denver	Colorado	United States	80230
13	Novartis Investigative Site	Lafayette	Colorado	United States	80026
14	Novartis Investigative Site	Miami Gardens	Florida	United States	33169
15	Novartis Investigative Site	Miami	Florida	United States	33176
16	Novartis Investigative Site	Tallahassee	Florida	United States	32308
17	Novartis Investigative Site	Winter Park	Florida	United States	32789
18	Novartis Investigative Site	Paducah	Kentucky	United States	42001
19	Novartis Investigative Site	Columbia	Maryland	United States	21044
20	Novartis Investigative Site	White Marsh	Maryland	United States	21162
21	Novartis Investigative Site	North Dartmouth	Massachusetts	United States	02747-3322
22	Novartis Investigative Site	Ann Arbor	Michigan	United States	48106
23	Novartis Investigative Site	Minneapolis	Minnesota	United States	55402
24	Novartis Investigative Site	Rochester	Minnesota	United States	55905
25	Novartis Investigative Site	Saint Charles	Missouri	United States	63301
26	Novartis Investigative Site	Saint Louis	Missouri	United States	63110
27	Novartis Investigative Site	Saint Louis	Missouri	United States	63141
28	Novartis Investigative Site	Warrensburg	Missouri	United States	64093
29	Novartis Investigative Site	Omaha	Nebraska	United States	68134
30	Novartis Investigative Site	Brooklyn	New York	United States	11235
31	Novartis Investigative Site	Raleigh	North Carolina	United States	27607
32	Novartis Investigative Site	Cincinnati	Ohio	United States	45245
33	Novartis Investigative Site	Columbus	Ohio	United States	43215
34	Novartis Investigative Site	Marion	Ohio	United States	43302
35	Novartis Investigative Site	Mayfield Heights	Ohio	United States	44124
36	Novartis Investigative Site	Tulsa	Oklahoma	United States	74136
37	Novartis Investigative Site	Altoona	Pennsylvania	United States	16602
38	Novartis Investigative Site	Pittsburgh	Pennsylvania	United States	15241
39	Novartis Investigative Site	Mount Pleasant	South Carolina	United States	29464
40	Novartis Investigative Site	Dallas	Texas	United States	75231
41	Novartis Investigative Site	New Braunfels	Texas	United States	78130
42	Novartis Investigative Site	San Antonio	Texas	United States	78205
43	Novartis Investigative Site	Murray	Utah	United States	84107
44	Novartis Investigative Site	Newport News	Virginia	United States	23606
45	Novartis Investigative Site	Spokane	Washington	United States	99204
46	Novartis Investigative Site	Goiania	GO	Brazil	74110-030
47	Novartis Investigative Site	Porto Alegre	Porto Alegre RS	Brazil	90610 000
48	Novartis Investigative Site	Porto Alegre	Rio Grande Do Sul	Brazil	90610-000
49	Novartis Investigative Site	Porto Alegre	RS	Brazil	90020-090
50	Novartis Investigative Site	Blumenau	Santa Catarina	Brazil	89030101
51	Novartis Investigative Site	Sao Bernardo do Campo	SP	Brazil	09715 090
52	Novartis Investigative Site	Sao Paulo	SP	Brazil	05437 010
53	Novartis Investigative Site	Sorocaba	SP	Brazil
54	Novartis Investigative Site	Pleven		Bulgaria	5800
55	Novartis Investigative Site	Ruse		Bulgaria	7002
56	Novartis Investigative Site	Sofia		Bulgaria	1000
57	Novartis Investigative Site	Stara Zagora		Bulgaria	6000
58	Novartis Investigative Site	Kingston	Ontario	Canada	K7L 2V7
59	Novartis Investigative Site	Toronto	Ontario	Canada	M6H 3M2
60	Novartis Investigative Site	Toronto	Ontario	Canada	M9V 4B4
61	Novartis Investigative Site	Windsor	Ontario	Canada	N8X 5A6
62	Novartis Investigative Site	Ibague	Tolima	Colombia	730006
63	Novartis Investigative Site	Bogota DC		Colombia	110221
64	Novartis Investigative Site	Bogota		Colombia	110111
65	Novartis Investigative Site	Bucaramanga		Colombia
66	Novartis Investigative Site	Berlin		Germany	10367
67	Novartis Investigative Site	Erlangen		Germany	91052
68	Novartis Investigative Site	Frankfurt		Germany	60389
69	Novartis Investigative Site	Halle		Germany	06108
70	Novartis Investigative Site	Hamburg		Germany	20354
71	Novartis Investigative Site	Hannover		Germany	30167
72	Novartis Investigative Site	Leipzig		Germany	04357
73	Novartis Investigative Site	Lubeck		Germany	23552
74	Novartis Investigative Site	Hajdunanas	HUN	Hungary	4080
75	Novartis Investigative Site	Kapuvár	HUN	Hungary	9330
76	Novartis Investigative Site	Puspokladany	HUN	Hungary	4150
77	Novartis Investigative Site	Budapest		Hungary	1106
78	Novartis Investigative Site	Pecs		Hungary	7635
79	Novartis Investigative Site	Siofok		Hungary	8600
80	Novartis Investigative Site	Szigetszentmiklos		Hungary	H-2310
81	Novartis Investigative Site	Ahmedabad	Gujarat	India	380 060
82	Novartis Investigative Site	Vadodara	Gujarat	India	390022
83	Novartis Investigative Site	Nashik	Maharastra	India	422007
84	Novartis Investigative Site	Bikaner	Rajasthan	India	334 001
85	Novartis Investigative Site	Coimbatore	Tamil Nadu	India	641 045
86	Novartis Investigative Site	DehraDun	Uttarakhand	India	248001
87	Novartis Investigative Site	Ashkelon		Israel	78278
88	Novartis Investigative Site	Haifa		Israel	3436212
89	Novartis Investigative Site	Jerusalem		Israel
90	Novartis Investigative Site	Rehovot		Israel	76100
91	Novartis Investigative Site	Brescia	BS	Italy	25123
92	Novartis Investigative Site	Firenze	FI	Italy	50134
93	Novartis Investigative Site	Rozzano	MI	Italy	20089
94	Novartis Investigative Site	Pisa	PI	Italy	56124
95	Novartis Investigative Site	Milano		Italy	20157
96	Novartis Investigative Site	Wonju	Gangwon-do	Korea, Republic of	26427
97	Novartis Investigative Site	Hwaseong si	Gyeonggi Do	Korea, Republic of	18450
98	Novartis Investigative Site	Suwon si	Gyeonggi Do	Korea, Republic of	16499
99	Novartis Investigative Site	Bucheon-Si	Gyeonggi-Do	Korea, Republic of	14584
100	Novartis Investigative Site	Seoul	Korea	Korea, Republic of	03312
101	Novartis Investigative Site	Seoul	Seocho Gu	Korea, Republic of	06591
102	Novartis Investigative Site	Daegu		Korea, Republic of	705703
103	Novartis Investigative Site	Incheon		Korea, Republic of	21431
104	Novartis Investigative Site	Seoul		Korea, Republic of	05505
105	Novartis Investigative Site	Cercado De Lima	Lima	Peru	01
106	Novartis Investigative Site	San Isidro	Lima	Peru	27
107	Novartis Investigative Site	San Martin de Porres	Lima	Peru	31
108	Novartis Investigative Site	Cusco		Peru	84
109	Novartis Investigative Site	Lima		Peru	1
110	Novartis Investigative Site	Piura		Peru	2000
111	Novartis Investigative Site	San Juan		Puerto Rico	00909
112	Novartis Investigative Site	Barnaul		Russian Federation	656024
113	Novartis Investigative Site	Chelyabinsk		Russian Federation	454021
114	Novartis Investigative Site	Moscow		Russian Federation	109544
115	Novartis Investigative Site	Moscow		Russian Federation	115478
116	Novartis Investigative Site	N.Novgorod		Russian Federation	603126
117	Novartis Investigative Site	Penza		Russian Federation	440067
118	Novartis Investigative Site	Perm		Russian Federation	614068
119	Novartis Investigative Site	Ryazan		Russian Federation	390039
120	Novartis Investigative Site	Saint Petersburg		Russian Federation	197022
121	Novartis Investigative Site	Saint-Petersburg		Russian Federation	191186
122	Novartis Investigative Site	St Petersburg		Russian Federation	194354
123	Novartis Investigative Site	Stavropol		Russian Federation	355000
124	Novartis Investigative Site	Yaroslavl		Russian Federation	150054
125	Novartis Investigative Site	Yekaterinburg		Russian Federation	620109
126	Novartis Investigative Site	Malaga	Andalucia	Spain	29010
127	Novartis Investigative Site	Marbella	Andalucia	Spain	29603
128	Novartis Investigative Site	Laredo	Cantabria	Spain	39770
129	Novartis Investigative Site	Pozuelo de Alarcon	Madrid	Spain	28223
130	Novartis Investigative Site	Barcelona	Vic	Spain	08500
131	Novartis Investigative Site	Barcelona		Spain	08006
132	Novartis Investigative Site	Barcelona		Spain	08540
133	Novartis Investigative Site	Girona		Spain	17005
134	Novartis Investigative Site	Santiago de Compostela		Spain	1506
135	Novartis Investigative Site	Zaragoza		Spain	50009
136	Novartis Investigative Site	Lund		Sweden	SE-221 85
137	Novartis Investigative Site	Umea		Sweden	907 40
138	Novartis Investigative Site	Visby		Sweden	621 50
139	Novartis Investigative Site	Bab saadoun		Tunisia	1007
140	Novartis Investigative Site	Hai Phong		Vietnam	180000
141	Novartis Investigative Site	Hanoi		Vietnam	100000
142	Novartis Investigative Site	Ho Chi Minh		Vietnam	700000

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - May 10, 2017
• Statistical Analysis Plan - Aug 25, 2019

More Information

Additional Information:

• A Plain Language Trial Summary is available on novartisclinicaltrials.com

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03226392
• Other Study ID Numbers: CQAW039A2317; 2017-001272-40
• First Posted: Jul 21, 2017
• Last Update Posted: Oct 7, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Novartis Pharmaceuticals: QAW039, uncontrolled asthma
• Additional relevant MeSH terms: Asthma

Study Results

Participant Flow

Recruitment Details	Participants were recruited from centers in Brazil (8), Bulgaria (4), Canada (3), Colombia (4), Germany (5), Hungary (7), India (5), Israel (5), Italy (4), Peru (6), Republic of Korea (5), Russian Federation (14), Spain (8), United States (36), Vietnam (3).

Arm/Group Title	QAW039	Placebo
Arm/Group Description	QAW039 150mg once daily	Placebo once daily
Period Title: Overall Study
STARTED	352	352
FAS	352	350
COMPLETED	341	344
NOT COMPLETED	11	8

Baseline Characteristics

Arm/Group Title	QAW039	Placebo	Total
Arm/Group Description	QAW039 150mg once daily	Placebo once daily	Total of all reporting groups
Overall Participants	352	350	702
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	50.4 (14.87)	50.2 (14.39)	50.3 (14.62)
Sex: Female, Male (Count of Participants)
Female	216 61.4%	218 62.3%	434 61.8%
Male	136 38.6%	132 37.7%	268 38.2%
Race/Ethnicity, Customized (Number) [Number]
Black	26 7.4%	18 5.1%	44 6.3%
Asian	41 11.6%	46 13.1%	87 12.4%
Native American	12 3.4%	12 3.4%	24 3.4%
Pacific Islander	2 0.6%	0 0%	2 0.3%
Other	55 15.6%	58 16.6%	113 16.1%
Caucasian	216 61.4%	216 61.7%	432 61.5%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Pre-dose FEV1
Description	Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS): all randomized patients who received at least one dose of study medication. Patients in the FAS were analyzed according to the treatment they were assigned to at randomization.

Arm/Group Title	QAW039	Placebo
Arm/Group Description	QAW039 150mg once daily	Placebo once daily
Measure Participants	352	350
Least Squares Mean (Standard Error) [Liters]	0.126 (0.00177)	0.157 (0.0177)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	QAW039, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.214
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.031
	Confidence Interval	(2-Sided) 95%; -0.080 to 0.018
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline in Daytime Asthma Symptom Score
Description	Daytime asthma symptoms are evaluated through four questions and each of them will be rated on a scale of 0 to 6. Higher scores indicate more severe asthma-related symptoms. A mean score is calculated for the responses to 4 questions.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS): all randomized patients who received at least one dose of study medication. Patients in the FAS were analyzed according to the treatment they were assigned to at randomization.

Arm/Group Title	QAW039	Placebo
Arm/Group Description	QAW039 150mg once daily	Placebo once daily
Measure Participants	352	350
Least Squares Mean (Standard Error) [Score]	-0.55 (0.034)	-0.45 (0.034)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	QAW039, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.035
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.10
	Confidence Interval	(2-Sided) 0.035%; -0.19 to 0.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in Number of Puffs of SABA Taken Per Day
Description	Daily use of SABA (the number of rescue medication puffs taken in the previous 12 hours) was recorded using a patient electronic diary (referred to as eDiary or eDiary/ePEF). Patients were instructed to routinely complete the patient diary twice daily - at the same time each morning and each evening, approximately 12 hours apart.
Time Frame	Baseline (daily mean for up to three weeks prior to baseline visit) and Week 12 (daily mean post baseline up to Week 12)

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS): all randomized patients who received at least one dose of study medication. Patients in the FAS were analyzed according to the treatment they were assigned to at randomization.

Arm/Group Title	QAW039	Placebo
Arm/Group Description	QAW039 150mg once daily	Placebo once daily
Measure Participants	352	350
Least Squares Mean (Standard Error) [Puffs per day]	-0.89 (0.066)	-0.88 (0.066)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	QAW039, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.893
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.093
	Confidence Interval	(2-Sided) 95%; -0.20 to 0.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ+12) Score
Description	AQLQ is a 32-item instrument administered as a self-assessment. AQLQ+12 is a modified version of AQLQ developed to measure functional impairments of participants aged 12-70 years. It is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Participants were asked to recall their experiences during the last 2 weeks and respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated "better quality of life." Overall AQLQ+12 score is the mean of all 32 responses.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS): all randomized patients who received at least one dose of study medication. Patients in the FAS were analyzed according to the treatment they were assigned to at randomization.

Arm/Group Title	QAW039	Placebo
Arm/Group Description	QAW039 150mg once daily	Placebo once daily
Measure Participants	352	350
Least Squares Mean (Standard Error) [units on a scale]	0.77 (0.043)	0.72 (0.043)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	QAW039, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.448
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.061
	Confidence Interval	(2-Sided) 95%; -0.07 to 0.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	After signing informed consent to 30 days after last dose, assessed up to 16 weeks.
Arm/Group Title	QAW039 150 mg		Placebo
Arm/Group Description	QAW039 150 mg		Placebo
All Cause Mortality
	QAW039 150 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/352 (0%)		0/350 (0%)
Serious Adverse Events
	QAW039 150 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/352 (2%)		3/350 (0.9%)
Cardiac disorders
Acute myocardial infarction	0/352 (0%)		1/350 (0.3%)
Gastrointestinal disorders
Upper gastrointestinal haemorrhage	1/352 (0.3%)		0/350 (0%)
General disorders
Non-cardiac chest pain	0/352 (0%)		1/350 (0.3%)
Hepatobiliary disorders
Cholecystitis acute	1/352 (0.3%)		0/350 (0%)
Infections and infestations
Cellulitis	1/352 (0.3%)		0/350 (0%)
Urinary tract infection	1/352 (0.3%)		0/350 (0%)
Injury, poisoning and procedural complications
Femur fracture	1/352 (0.3%)		0/350 (0%)
Hip fracture	0/352 (0%)		1/350 (0.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer	1/352 (0.3%)		0/350 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	3/352 (0.9%)		0/350 (0%)
Other (Not Including Serious) Adverse Events
	QAW039 150 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	94/352 (26.7%)		116/350 (33.1%)
Infections and infestations
Bronchitis	9/352 (2.6%)		6/350 (1.7%)
Influenza	4/352 (1.1%)		1/350 (0.3%)
Nasopharyngitis	10/352 (2.8%)		24/350 (6.9%)
Pharyngitis	5/352 (1.4%)		2/350 (0.6%)
Respiratory tract infection viral	5/352 (1.4%)		1/350 (0.3%)
Upper respiratory tract infection	7/352 (2%)		10/350 (2.9%)
Upper respiratory tract infection bacterial	3/352 (0.9%)		6/350 (1.7%)
Viral upper respiratory tract infection	12/352 (3.4%)		8/350 (2.3%)
Injury, poisoning and procedural complications
Contusion	0/352 (0%)		5/350 (1.4%)
Musculoskeletal and connective tissue disorders
Back pain	7/352 (2%)		7/350 (2%)
Nervous system disorders
Headache	5/352 (1.4%)		14/350 (4%)
Respiratory, thoracic and mediastinal disorders
Asthma	46/352 (13.1%)		61/350 (17.4%)
Cough	2/352 (0.6%)		5/350 (1.4%)
Dyspnoea	3/352 (0.9%)		5/350 (1.4%)
Oropharyngeal pain	6/352 (1.7%)		4/350 (1.1%)
Rhinitis allergic	3/352 (0.9%)		5/350 (1.4%)
Wheezing	1/352 (0.3%)		4/350 (1.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.