Trial Outcomes & Findings for A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients (NCT NCT01836471)
NCT ID: NCT01836471
Last Updated: 2017-03-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
345 participants
Primary outcome timeframe
baseline,12 weeks
Results posted on
2017-03-20
Participant Flow
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)
Participant milestones
| Measure |
QAW039 450 mg qd Non-atopic
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 Non-atopic
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 Atopic
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 Bid Atopic
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 Atopic
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 Study
STARTED
|
93
|
94
|
51
|
42
|
54
|
|
Overall Study
COMPLETED
|
82
|
85
|
49
|
40
|
49
|
|
Overall Study
NOT COMPLETED
|
11
|
9
|
2
|
2
|
5
|
Reasons for withdrawal
| Measure |
QAW039 450 mg qd Non-atopic
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 Non-atopic
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 Atopic
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 Bid Atopic
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 Atopic
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 Study
Pregnancy
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
1
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Adverse Event
|
6
|
3
|
1
|
1
|
2
|
|
Overall Study
Non compliance with tx
|
1
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients
Baseline characteristics by cohort
| Measure |
QAW039 450 mg qd Non-atopic
n=93 Participants
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 Non-atopic
n=94 Participants
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 Atopic
n=51 Participants
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 Bid Atopic
n=42 Participants
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 Atopic
n=54 Participants
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
n=334 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.9 years
STANDARD_DEVIATION 14.33 • n=5 Participants
|
53.5 years
STANDARD_DEVIATION 14.37 • n=7 Participants
|
50.3 years
STANDARD_DEVIATION 12.75 • n=5 Participants
|
48.2 years
STANDARD_DEVIATION 12.16 • n=4 Participants
|
48.2 years
STANDARD_DEVIATION 13.58 • n=21 Participants
|
51.0 years
STANDARD_DEVIATION 13.81 • n=10 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
194 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
140 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
2 participants
n=21 Participants
|
13 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
4 participants
n=5 Participants
|
6 participants
n=4 Participants
|
3 participants
n=21 Participants
|
44 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
4 participants
n=21 Participants
|
22 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
68 participants
n=5 Participants
|
68 participants
n=7 Participants
|
40 participants
n=5 Participants
|
29 participants
n=4 Participants
|
43 participants
n=21 Participants
|
248 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
6 participants
n=10 Participants
|
|
Duration of asthma
|
14.88 years
STANDARD_DEVIATION 12.349 • n=5 Participants
|
12.82 years
STANDARD_DEVIATION 12.196 • n=7 Participants
|
24.69 years
STANDARD_DEVIATION 17.446 • n=5 Participants
|
27.78 years
STANDARD_DEVIATION 18.039 • n=4 Participants
|
24.09 years
STANDARD_DEVIATION 16.055 • n=21 Participants
|
18.91 years
STANDARD_DEVIATION 15.648 • n=10 Participants
|
|
Subject population
Non-atopic
|
93 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
187 Participants
n=10 Participants
|
|
Subject population
Atopic
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
147 Participants
n=10 Participants
|
|
Percentage of predicted FEV1 (%) pre-bronchodilator
|
67.5446 Percentage
STANDARD_DEVIATION 11.81404 • n=5 Participants
|
65.7286 Percentage
STANDARD_DEVIATION 13.94056 • n=7 Participants
|
69.0662 Percentage
STANDARD_DEVIATION 12.16292 • n=5 Participants
|
68.7483 Percentage
STANDARD_DEVIATION 10.52156 • n=4 Participants
|
64.8709 Percentage
STANDARD_DEVIATION 12.97729 • n=21 Participants
|
66.9849 Percentage
STANDARD_DEVIATION 12.56166 • n=10 Participants
|
|
ACQ-6 score
|
1.70 points
STANDARD_DEVIATION 0.762 • n=5 Participants
|
1.53 points
STANDARD_DEVIATION 0.745 • n=7 Participants
|
1.55 points
STANDARD_DEVIATION 0.665 • n=5 Participants
|
1.68 points
STANDARD_DEVIATION 0.749 • n=4 Participants
|
1.72 points
STANDARD_DEVIATION 0.675 • n=21 Participants
|
1.63 points
STANDARD_DEVIATION 0.728 • n=10 Participants
|
PRIMARY outcome
Timeframe: baseline,12 weeksForced 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.
Outcome measures
| Measure |
QAW039 450 mg qd Non-atopic
n=91 Participants
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 Non-atopic
n=93 Participants
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.
|
Placebo Atopic
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.
|
Fluticasone 150 µg Bid Atopic
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 Atopic
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.
|
|---|---|---|---|---|---|
|
Change From Baseline in Trough FEV1 (L) in Non-atopic Patients at Week 12 - Full Analysis Set
|
0.05 liter
Standard Error 0.029
|
0.03 liter
Standard Error 0.029
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline,12 weeksForced 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.
Outcome measures
| Measure |
QAW039 450 mg qd Non-atopic
n=50 Participants
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 Non-atopic
n=41 Participants
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.
|
Placebo Atopic
n=52 Participants
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.
|
Fluticasone 150 µg Bid Atopic
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 Atopic
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.
|
|---|---|---|---|---|---|
|
Change From Baseline in Trough FEV1 (L) in Atopic Patients at Week 12 - Full Analysis Set
|
0.06 liter
Standard Error 0.038
|
0.01 liter
Standard Error 0.042
|
0.05 liter
Standard Error 0.037
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline,12 weeksForced 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.
Outcome measures
| Measure |
QAW039 450 mg qd Non-atopic
n=91 Participants
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 Non-atopic
n=93 Participants
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.
|
Placebo Atopic
n=50 Participants
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.
|
Fluticasone 150 µg Bid Atopic
n=41 Participants
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 Atopic
n=52 Participants
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.
|
|---|---|---|---|---|---|
|
Change From Baseline in Trough FEV1 (L) in Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set
|
0.05 liter
Standard Error 0.029
|
0.03 liter
Standard Error 0.029
|
0.06 liter
Standard Error 0.038
|
0.01 liter
Standard Error 0.042
|
0.05 liter
Standard Error 0.037
|
SECONDARY outcome
Timeframe: baseline,12 weeksACQ-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.
Outcome measures
| Measure |
QAW039 450 mg qd Non-atopic
n=80 Participants
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 Non-atopic
n=85 Participants
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.
|
Placebo Atopic
n=48 Participants
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.
|
Fluticasone 150 µg Bid Atopic
n=40 Participants
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 Atopic
n=48 Participants
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.
|
|---|---|---|---|---|---|
|
Change From Baseline in ACQ-6 Score at Week 12 Non-atopic and Atopic Patients at Week 12 - Full Analysis Set
|
-0.05 score
Standard Error 0.077
|
-0.03 score
Standard Error 0.073
|
-0.25 score
Standard Error 0.096
|
-0.35 score
Standard Error 0.104
|
-0.18 score
Standard Error 0.096
|
SECONDARY outcome
Timeframe: baseline,12 weeksACQ-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.
Outcome measures
| Measure |
QAW039 450 mg qd Non-atopic
n=80 Participants
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 Non-atopic
n=85 Participants
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.
|
Placebo Atopic
n=48 Participants
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.
|
Fluticasone 150 µg Bid Atopic
n=40 Participants
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 Atopic
n=48 Participants
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.
|
|---|---|---|---|---|---|
|
Change From Baseline in ACQ-6 Score at Week 12 Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set
|
-0.05 score
Standard Error 0.077
|
-0.03 score
Standard Error 0.073
|
-0.25 score
Standard Error 0.096
|
-0.35 score
Standard Error 0.104
|
-0.18 score
Standard Error 0.096
|
Adverse Events
QAW039 450 mg qd
Serious events: 2 serious events
Other events: 36 other events
Deaths: 0 deaths
Fluticasone 150 mcg Bid
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
QAW039 450 mg qd
n=145 participants at risk
QAW039 450 mg qd
|
Fluticasone 150 mcg Bid
n=42 participants at risk
Fluticasone 150 mcg bid
|
Placebo
n=147 participants at risk
Placebo
|
|---|---|---|---|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/145 • Timeframe for AE
AE additional description
|
0.00%
0/42 • Timeframe for AE
AE additional description
|
0.68%
1/147 • Timeframe for AE
AE additional description
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
0.00%
0/145 • Timeframe for AE
AE additional description
|
0.00%
0/42 • Timeframe for AE
AE additional description
|
0.68%
1/147 • Timeframe for AE
AE additional description
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.69%
1/145 • Timeframe for AE
AE additional description
|
0.00%
0/42 • Timeframe for AE
AE additional description
|
0.00%
0/147 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/145 • Timeframe for AE
AE additional description
|
0.00%
0/42 • Timeframe for AE
AE additional description
|
0.68%
1/147 • Timeframe for AE
AE additional description
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.69%
1/145 • Timeframe for AE
AE additional description
|
0.00%
0/42 • Timeframe for AE
AE additional description
|
0.00%
0/147 • Timeframe for AE
AE additional description
|
Other adverse events
| Measure |
QAW039 450 mg qd
n=145 participants at risk
QAW039 450 mg qd
|
Fluticasone 150 mcg Bid
n=42 participants at risk
Fluticasone 150 mcg bid
|
Placebo
n=147 participants at risk
Placebo
|
|---|---|---|---|
|
Gastrointestinal disorders
DENTAL CARIES
|
0.00%
0/145 • Timeframe for AE
AE additional description
|
2.4%
1/42 • Timeframe for AE
AE additional description
|
0.00%
0/147 • Timeframe for AE
AE additional description
|
|
Gastrointestinal disorders
NAUSEA
|
0.69%
1/145 • Timeframe for AE
AE additional description
|
2.4%
1/42 • Timeframe for AE
AE additional description
|
0.68%
1/147 • Timeframe for AE
AE additional description
|
|
Infections and infestations
ACUTE SINUSITIS
|
0.00%
0/145 • Timeframe for AE
AE additional description
|
0.00%
0/42 • Timeframe for AE
AE additional description
|
2.0%
3/147 • Timeframe for AE
AE additional description
|
|
Infections and infestations
BRONCHITIS
|
2.1%
3/145 • Timeframe for AE
AE additional description
|
0.00%
0/42 • Timeframe for AE
AE additional description
|
2.7%
4/147 • Timeframe for AE
AE additional description
|
|
Infections and infestations
CONJUNCTIVITIS VIRAL
|
0.00%
0/145 • Timeframe for AE
AE additional description
|
2.4%
1/42 • Timeframe for AE
AE additional description
|
0.00%
0/147 • Timeframe for AE
AE additional description
|
|
Infections and infestations
INFLUENZA
|
1.4%
2/145 • Timeframe for AE
AE additional description
|
0.00%
0/42 • Timeframe for AE
AE additional description
|
2.0%
3/147 • Timeframe for AE
AE additional description
|
|
Infections and infestations
NASOPHARYNGITIS
|
3.4%
5/145 • Timeframe for AE
AE additional description
|
2.4%
1/42 • Timeframe for AE
AE additional description
|
2.0%
3/147 • Timeframe for AE
AE additional description
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.00%
0/145 • Timeframe for AE
AE additional description
|
2.4%
1/42 • Timeframe for AE
AE additional description
|
0.68%
1/147 • Timeframe for AE
AE additional description
|
|
Infections and infestations
PHARYNGITIS
|
0.69%
1/145 • Timeframe for AE
AE additional description
|
2.4%
1/42 • Timeframe for AE
AE additional description
|
0.00%
0/147 • Timeframe for AE
AE additional description
|
|
Infections and infestations
RHINITIS
|
1.4%
2/145 • Timeframe for AE
AE additional description
|
4.8%
2/42 • Timeframe for AE
AE additional description
|
0.00%
0/147 • Timeframe for AE
AE additional description
|
|
Infections and infestations
SINUSITIS BACTERIAL
|
2.1%
3/145 • Timeframe for AE
AE additional description
|
0.00%
0/42 • Timeframe for AE
AE additional description
|
0.00%
0/147 • Timeframe for AE
AE additional description
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/145 • Timeframe for AE
AE additional description
|
2.4%
1/42 • Timeframe for AE
AE additional description
|
0.00%
0/147 • Timeframe for AE
AE additional description
|
|
Infections and infestations
TONSILLITIS
|
0.00%
0/145 • Timeframe for AE
AE additional description
|
2.4%
1/42 • Timeframe for AE
AE additional description
|
0.00%
0/147 • Timeframe for AE
AE additional description
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
4.8%
7/145 • Timeframe for AE
AE additional description
|
2.4%
1/42 • Timeframe for AE
AE additional description
|
3.4%
5/147 • Timeframe for AE
AE additional description
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
1.4%
2/145 • Timeframe for AE
AE additional description
|
2.4%
1/42 • Timeframe for AE
AE additional description
|
2.0%
3/147 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
0.00%
0/145 • Timeframe for AE
AE additional description
|
2.4%
1/42 • Timeframe for AE
AE additional description
|
0.00%
0/147 • Timeframe for AE
AE additional description
|
|
Injury, poisoning and procedural complications
WOUND
|
0.00%
0/145 • Timeframe for AE
AE additional description
|
2.4%
1/42 • Timeframe for AE
AE additional description
|
0.00%
0/147 • Timeframe for AE
AE additional description
|
|
Investigations
BLOOD TRIGLYCERIDES INCREASED
|
0.69%
1/145 • Timeframe for AE
AE additional description
|
2.4%
1/42 • Timeframe for AE
AE additional description
|
0.00%
0/147 • Timeframe for AE
AE additional description
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
0.69%
1/145 • Timeframe for AE
AE additional description
|
4.8%
2/42 • Timeframe for AE
AE additional description
|
0.00%
0/147 • Timeframe for AE
AE additional description
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.69%
1/145 • Timeframe for AE
AE additional description
|
2.4%
1/42 • Timeframe for AE
AE additional description
|
0.68%
1/147 • Timeframe for AE
AE additional description
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.00%
0/145 • Timeframe for AE
AE additional description
|
2.4%
1/42 • Timeframe for AE
AE additional description
|
0.00%
0/147 • Timeframe for AE
AE additional description
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/145 • Timeframe for AE
AE additional description
|
2.4%
1/42 • Timeframe for AE
AE additional description
|
0.00%
0/147 • Timeframe for AE
AE additional description
|
|
Musculoskeletal and connective tissue disorders
SYNOVIAL CYST
|
0.00%
0/145 • Timeframe for AE
AE additional description
|
2.4%
1/42 • Timeframe for AE
AE additional description
|
0.00%
0/147 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
HEADACHE
|
0.69%
1/145 • Timeframe for AE
AE additional description
|
0.00%
0/42 • Timeframe for AE
AE additional description
|
2.0%
3/147 • Timeframe for AE
AE additional description
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/145 • Timeframe for AE
AE additional description
|
2.4%
1/42 • Timeframe for AE
AE additional description
|
0.00%
0/147 • Timeframe for AE
AE additional description
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/145 • Timeframe for AE
AE additional description
|
2.4%
1/42 • Timeframe for AE
AE additional description
|
0.00%
0/147 • Timeframe for AE
AE additional description
|
|
Reproductive system and breast disorders
DYSMENORRHOEA
|
0.00%
0/145 • Timeframe for AE
AE additional description
|
2.4%
1/42 • Timeframe for AE
AE additional description
|
0.68%
1/147 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
6.9%
10/145 • Timeframe for AE
AE additional description
|
4.8%
2/42 • Timeframe for AE
AE additional description
|
8.8%
13/147 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
2.1%
3/145 • Timeframe for AE
AE additional description
|
0.00%
0/42 • Timeframe for AE
AE additional description
|
0.68%
1/147 • Timeframe for AE
AE additional description
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.69%
1/145 • Timeframe for AE
AE additional description
|
0.00%
0/42 • Timeframe for AE
AE additional description
|
2.0%
3/147 • Timeframe for AE
AE additional description
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
0.00%
0/145 • Timeframe for AE
AE additional description
|
4.8%
2/42 • Timeframe for AE
AE additional description
|
0.00%
0/147 • Timeframe for AE
AE additional description
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.00%
0/145 • Timeframe for AE
AE additional description
|
2.4%
1/42 • Timeframe for AE
AE additional description
|
0.00%
0/147 • Timeframe for AE
AE additional description
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/145 • Timeframe for AE
AE additional description
|
2.4%
1/42 • Timeframe for AE
AE additional description
|
0.00%
0/147 • Timeframe for AE
AE additional description
|
Additional Information
Study Director
Novaratis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER