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A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01836471
Recruitment Status : Completed
First Posted : April 22, 2013
Results First Posted : March 20, 2017
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: QAW039
Drug: Placebo QAW039
Drug: Fluticasone 250 mcg
Drug: Fluticasone 100 mcg
Enrollment 345
Recruitment Details  
Pre-assignment Details Total of 939 subjects were screened, 679 entered the inhaled corticosteroid (ICS) tapering run-in, 345 subjects were randomized; eleven randomized subjects discontinued the study prior to start of study drug. Patient disposition and baseline characteristics were presented for 334 subjects (received study drug)
Arm/Group Title QAW039 450 mg qd Non-atopic Placebo Non-atopic QAW039 450 mg qd Atopic Fluticasone 150 µg Bid Atopic Placebo Atopic
Hide Arm/Group Description QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo. Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo. QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo. Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo. Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
Period Title: Overall Study
Started 93 94 51 42 54
Completed 82 85 49 40 49
Not Completed 11 9 2 2 5
Reason Not Completed
Pregnancy             1             0             0             0             0
Withdrawal by Subject             3             4             1             0             2
Physician Decision             0             1             0             0             0
Lost to Follow-up             0             0             0             1             1
Adverse Event             6             3             1             1             2
Non compliance with tx             1             1             0             0             0
Arm/Group Title QAW039 450 mg qd Non-atopic Placebo Non-atopic QAW039 450 mg qd Atopic Fluticasone 150 µg Bid Atopic Placebo Atopic Total
Hide Arm/Group Description QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo. Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo. QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo. Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo. Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo. Total of all reporting groups
Overall Number of Baseline Participants 93 94 51 42 54 334
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 93 participants 94 participants 51 participants 42 participants 54 participants 334 participants
51.9  (14.33) 53.5  (14.37) 50.3  (12.75) 48.2  (12.16) 48.2  (13.58) 51.0  (13.81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 94 participants 51 participants 42 participants 54 participants 334 participants
Female
60
  64.5%
60
  63.8%
26
  51.0%
23
  54.8%
25
  46.3%
194
  58.1%
Male
33
  35.5%
34
  36.2%
25
  49.0%
19
  45.2%
29
  53.7%
140
  41.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 93 participants 94 participants 51 participants 42 participants 54 participants 334 participants
American Indian or Alaska Native 2 3 3 3 2 13
Asian 15 16 4 6 3 44
Native Hawaiian or Other Pacific Islander 0 0 0 0 1 1
Black or African American 6 6 3 3 4 22
White 68 68 40 29 43 248
More than one race 0 0 0 0 0 0
Unknown or Not Reported 0 0 0 0 0 0
Other 2 1 1 1 1 6
Duration of asthma  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 93 participants 94 participants 51 participants 42 participants 54 participants 334 participants
14.88  (12.349) 12.82  (12.196) 24.69  (17.446) 27.78  (18.039) 24.09  (16.055) 18.91  (15.648)
Subject population   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 93 participants 94 participants 51 participants 42 participants 54 participants 334 participants
Non-atopic 93 94 0 0 0 187
Atopic 0 0 51 42 54 147
[1]
Measure Description: Non-atopic defined as history of perennial symptoms with no clear inhaled allergic trigger AND a negative skin prick test (< 3mm diameter above background) or a negative specific IgE (<0.35 IU eq./ml). Atopic/allergic defined as skin prick test (≥ 3mm diameter above background) or a positive specific IgE (e.g.,RAST/CAP) test (≥0.35 IU eq/ml)
Percentage of predicted FEV1 (%) pre-bronchodilator  
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 93 participants 94 participants 51 participants 42 participants 54 participants 334 participants
67.5446  (11.81404) 65.7286  (13.94056) 69.0662  (12.16292) 68.7483  (10.52156) 64.8709  (12.97729) 66.9849  (12.56166)
ACQ-6 score   [1] 
Mean (Standard Deviation)
Unit of measure:  Points
Number Analyzed 93 participants 94 participants 51 participants 42 participants 54 participants 334 participants
1.70  (0.762) 1.53  (0.745) 1.55  (0.665) 1.68  (0.749) 1.72  (0.675) 1.63  (0.728)
[1]
Measure Description: Number of participants (n=92,94,51,42,54)
1.Primary Outcome
Title Change From Baseline in Trough FEV1 (L) in Non-atopic Patients at Week 12 - Full Analysis Set
Hide 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.

Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF).

Estimates are from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug.

Time Frame baseline,12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title QAW039 450 mg qd Non-atopic Placebo Non-atopic
Hide Arm/Group Description:
QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
Overall Number of Participants Analyzed 91 93
Least Squares Mean (Standard Error)
Unit of Measure: liter
0.05  (0.029) 0.03  (0.029)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QAW039 450 mg qd Non-atopic, Placebo Non-atopic
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7269
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter least squares mean
Estimated Value 0.01
Confidence Interval (2-Sided) 90%
-0.5 to 0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.038
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Trough FEV1 (L) in Atopic Patients at Week 12 - Full Analysis Set
Hide 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 FEV1 measurement taken prior to the first dose of randomized study drug.

Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF).

Estimates are from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug.

Time Frame baseline,12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title QAW039 450 mg qd Atopic Fluticasone 150 µg Bid Atopic Placebo Atopic
Hide Arm/Group Description:
QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
Overall Number of Participants Analyzed 50 41 52
Least Squares Mean (Standard Error)
Unit of Measure: liter
0.06  (0.038) 0.01  (0.042) 0.05  (0.037)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QAW039 450 mg qd Atopic, Placebo Atopic
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter least sqares mean
Estimated Value 0.01
Confidence Interval (2-Sided) 90%
-0.08 to 0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.050
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QAW039 450 mg qd Atopic, Fluticasone 150 µg Bid Atopic
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter least squares mean
Estimated Value 0.04
Confidence Interval (2-Sided) 90%
-0.04 to 0.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.054
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fluticasone 150 µg Bid Atopic, Placebo Atopic
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter least squares mean
Estimated Value -0.04
Confidence Interval (2-Sided) 90%
-0.13 to 0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.053
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Trough FEV1 (L) in Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set
Hide 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 FEV1 measurement taken prior to the first dose of randomized study drug.

Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF).

Estimates are from a mixed effects model with treatment, subject population, treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug.

Time Frame baseline,12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title QAW039 450 mg qd Non-atopic Placebo Non-atopic QAW039 450 mg qd Atopic Fluticasone 150 µg Bid Atopic Placebo Atopic
Hide Arm/Group Description:
QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
Overall Number of Participants Analyzed 91 93 50 41 52
Least Squares Mean (Standard Error)
Unit of Measure: liter
0.05  (0.029) 0.03  (0.029) 0.06  (0.038) 0.01  (0.042) 0.05  (0.037)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QAW039 450 mg qd Non-atopic, Placebo Non-atopic, QAW039 450 mg qd Atopic, Fluticasone 150 µg Bid Atopic, Placebo Atopic
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9179
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in ACQ-6 Score at Week 12 Non-atopic and Atopic Patients at Week 12 - Full Analysis Set
Hide Description ACQ-6 consists of:5 items on symptoms, 1 item on rescue bronchodilator use, and 1 item on airway caliber (FEV1 % predicted). The ACQ was fully validated, including a minimal important difference (MID) or smallest change that could be considered clinically important (0.5). The ACQ was self-administered at the clinic and patients scored each item on a 7-point response scale: 0 = ‘totally controlled’ and 6 = ‘severely uncontrolled.’ Study staff scored question 7 based on % predicted FEV1 (ideally pre-bronchodilator). The total score=average of first 6 questions. Baseline=the ACQ-6 measurement taken prior to first dose of randomized study drug. The single missing score was interpolated by utilizing prior or subsequent completions of the questionnaire. Estimates were from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline ACQ-6 and region as fixed effects and center nested within region as random effects.
Time Frame baseline,12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title QAW039 450 mg qd Non-atopic Placebo Non-atopic QAW039 450 mg qd Atopic Fluticasone 150 µg Bid Atopic Placebo Atopic
Hide Arm/Group Description:
QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
Overall Number of Participants Analyzed 80 85 48 40 48
Least Squares Mean (Standard Error)
Unit of Measure: score
-0.05  (0.077) -0.03  (0.073) -0.25  (0.096) -0.35  (0.104) -0.18  (0.096)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QAW039 450 mg qd Non-atopic, Placebo Non-atopic
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter least squares mean
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.22 to 0.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.098
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QAW039 450 mg qd Atopic, Placebo Atopic
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter least sqares mean
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.32 to 0.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.128
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QAW039 450 mg qd Atopic, Fluticasone 150 µg Bid Atopic
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter least squares mean
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.16 to 0.37
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.134
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Fluticasone 150 µg Bid Atopic, Placebo Atopic
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter least squares mean
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.43 to 0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.134
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in ACQ-6 Score at Week 12 Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set
Hide Description ACQ-6 consists of:5 items on symptoms, 1 item on rescue bronchodilator use, and 1 item on airway caliber (FEV1 % predicted). The ACQ was fully validated, including a minimal important difference (MID) or smallest change that could be considered clinically important (0.5). The ACQ was self-administered at the clinic and patients scored each item on a 7-point response scale: 0 = ‘totally controlled’ and 6 = ‘severely uncontrolled.’ Study staff scored question 7 based on % predicted FEV1 (ideally pre-bronchodilator). The total score=average of first 6 questions. Baseline=the ACQ-6 measurement taken prior to first dose of randomized study drug. The single missing score was interpolated by utilizing prior or subsequent completions of the questionnaire. Estimates were from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline ACQ-6 and region as fixed effects and center nested within region as random effects.
Time Frame baseline,12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title QAW039 450 mg qd Non-atopic Placebo Non-atopic QAW039 450 mg qd Atopic Fluticasone 150 µg Bid Atopic Placebo Atopic
Hide Arm/Group Description:
QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
Overall Number of Participants Analyzed 80 85 48 40 48
Least Squares Mean (Standard Error)
Unit of Measure: score
-0.05  (0.077) -0.03  (0.073) -0.25  (0.096) -0.35  (0.104) -0.18  (0.096)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QAW039 450 mg qd Non-atopic, Placebo Non-atopic, QAW039 450 mg qd Atopic, Fluticasone 150 µg Bid Atopic, Placebo Atopic
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7930
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame Timeframe for AE
Adverse Event Reporting Description AE additional description
 
Arm/Group Title QAW039 450 mg qd Fluticasone 150 mcg Bid Placebo
Hide Arm/Group Description QAW039 450 mg qd Fluticasone 150 mcg bid Placebo
All-Cause Mortality
QAW039 450 mg qd Fluticasone 150 mcg Bid Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
QAW039 450 mg qd Fluticasone 150 mcg Bid Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/145 (1.38%)   0/42 (0.00%)   3/147 (2.04%) 
Cardiac disorders       
CORONARY ARTERY DISEASE  1  0/145 (0.00%)  0/42 (0.00%)  1/147 (0.68%) 
Hepatobiliary disorders       
HEPATIC STEATOSIS  1  0/145 (0.00%)  0/42 (0.00%)  1/147 (0.68%) 
Immune system disorders       
ANAPHYLACTIC REACTION  1  1/145 (0.69%)  0/42 (0.00%)  0/147 (0.00%) 
Nervous system disorders       
PRESYNCOPE  1  0/145 (0.00%)  0/42 (0.00%)  1/147 (0.68%) 
Reproductive system and breast disorders       
OVARIAN CYST  1  1/145 (0.69%)  0/42 (0.00%)  0/147 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
QAW039 450 mg qd Fluticasone 150 mcg Bid Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   36/145 (24.83%)   19/42 (45.24%)   35/147 (23.81%) 
Gastrointestinal disorders       
DENTAL CARIES  1  0/145 (0.00%)  1/42 (2.38%)  0/147 (0.00%) 
NAUSEA  1  1/145 (0.69%)  1/42 (2.38%)  1/147 (0.68%) 
Infections and infestations       
ACUTE SINUSITIS  1  0/145 (0.00%)  0/42 (0.00%)  3/147 (2.04%) 
BRONCHITIS  1  3/145 (2.07%)  0/42 (0.00%)  4/147 (2.72%) 
CONJUNCTIVITIS VIRAL  1  0/145 (0.00%)  1/42 (2.38%)  0/147 (0.00%) 
INFLUENZA  1  2/145 (1.38%)  0/42 (0.00%)  3/147 (2.04%) 
NASOPHARYNGITIS  1  5/145 (3.45%)  1/42 (2.38%)  3/147 (2.04%) 
ORAL CANDIDIASIS  1  0/145 (0.00%)  1/42 (2.38%)  1/147 (0.68%) 
PHARYNGITIS  1  1/145 (0.69%)  1/42 (2.38%)  0/147 (0.00%) 
RHINITIS  1  2/145 (1.38%)  2/42 (4.76%)  0/147 (0.00%) 
SINUSITIS BACTERIAL  1  3/145 (2.07%)  0/42 (0.00%)  0/147 (0.00%) 
SKIN INFECTION  1  0/145 (0.00%)  1/42 (2.38%)  0/147 (0.00%) 
TONSILLITIS  1  0/145 (0.00%)  1/42 (2.38%)  0/147 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  7/145 (4.83%)  1/42 (2.38%)  5/147 (3.40%) 
VIRAL UPPER RESPIRATORY TRACT INFECTION  1  2/145 (1.38%)  1/42 (2.38%)  3/147 (2.04%) 
Injury, poisoning and procedural complications       
LIGAMENT SPRAIN  1  0/145 (0.00%)  1/42 (2.38%)  0/147 (0.00%) 
WOUND  1  0/145 (0.00%)  1/42 (2.38%)  0/147 (0.00%) 
Investigations       
BLOOD TRIGLYCERIDES INCREASED  1  1/145 (0.69%)  1/42 (2.38%)  0/147 (0.00%) 
ELECTROCARDIOGRAM QT PROLONGED  1  1/145 (0.69%)  2/42 (4.76%)  0/147 (0.00%) 
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  1/145 (0.69%)  1/42 (2.38%)  1/147 (0.68%) 
ARTHRITIS  1  0/145 (0.00%)  1/42 (2.38%)  0/147 (0.00%) 
MUSCULOSKELETAL PAIN  1  0/145 (0.00%)  1/42 (2.38%)  0/147 (0.00%) 
SYNOVIAL CYST  1  0/145 (0.00%)  1/42 (2.38%)  0/147 (0.00%) 
Nervous system disorders       
HEADACHE  1  1/145 (0.69%)  0/42 (0.00%)  3/147 (2.04%) 
SYNCOPE  1  0/145 (0.00%)  1/42 (2.38%)  0/147 (0.00%) 
Renal and urinary disorders       
HAEMATURIA  1  0/145 (0.00%)  1/42 (2.38%)  0/147 (0.00%) 
Reproductive system and breast disorders       
DYSMENORRHOEA  1  0/145 (0.00%)  1/42 (2.38%)  1/147 (0.68%) 
Respiratory, thoracic and mediastinal disorders       
ASTHMA  1  10/145 (6.90%)  2/42 (4.76%)  13/147 (8.84%) 
COUGH  1  3/145 (2.07%)  0/42 (0.00%)  1/147 (0.68%) 
PRODUCTIVE COUGH  1  1/145 (0.69%)  0/42 (0.00%)  3/147 (2.04%) 
Skin and subcutaneous tissue disorders       
DERMATITIS CONTACT  1  0/145 (0.00%)  2/42 (4.76%)  0/147 (0.00%) 
ECZEMA  1  0/145 (0.00%)  1/42 (2.38%)  0/147 (0.00%) 
ERYTHEMA  1  0/145 (0.00%)  1/42 (2.38%)  0/147 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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 (i.e., data from all sites) in the clinical trial.
Results Point of Contact
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Name/Title: Study Director
Organization: Novaratis Pharmaceuticals
Phone: 862-778-8300
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Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01836471     History of Changes
Other Study ID Numbers: CQAW039A2214
2012-003995-38 ( EudraCT Number )
First Submitted: April 17, 2013
First Posted: April 22, 2013
Results First Submitted: January 30, 2017
Results First Posted: March 20, 2017
Last Update Posted: March 20, 2017