Trial · NCT01836471

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

NCT01836471, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2017-03-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients. Trials, record NCT01836471. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01836471

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients
NCT number: NCT01836471
Status: Completed
Phases: Phase 2
Enrollment: 345 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Asthma
Interventions: QAW039, Placebo QAW039, Fluticasone 250 mcg, Fluticasone 100 mcg
First posted: 2013-04-22
Last updated: 2017-03-20
Other registries' IDs: eudract:2012-003995-38
Results first posted: 2017-03-20

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Trough FEV1 (L) in Non-atopic Patients at Week 12 - Full Analysis Set	baseline,12 weeks	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.
Secondary	Change From Baseline in Trough FEV1 (L) in Atopic Patients at Week 12 - Full Analysis Set	baseline,12 weeks	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.
Secondary	Change From Baseline in Trough FEV1 (L) in Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set	baseline,12 weeks	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.
Secondary	Change From Baseline in ACQ-6 Score at Week 12 Non-atopic and Atopic Patients at Week 12 - Full Analysis Set	baseline,12 weeks	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.
Secondary	Change From Baseline in ACQ-6 Score at Week 12 Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set	baseline,12 weeks	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change From Baseline in Trough FEV1 (L) in Non-atopic Patients at Week 12 - Full Analysis Set	baseline,12 weeks	liter	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Trough FEV1 (L) in Atopic Patients at Week 12 - Full Analysis Set	baseline,12 weeks	liter	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Trough FEV1 (L) in Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set	baseline,12 weeks	liter	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in ACQ-6 Score at Week 12 Non-atopic and Atopic Patients at Week 12 - Full Analysis Set	baseline,12 weeks	score	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in ACQ-6 Score at Week 12 Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set	baseline,12 weeks	score	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Trough FEV1 (L) in Non-atopic Patients at Week 12 - Full Analysis Set	QAW039 450 mg qd Non-atopic	0.05	Standard Error 0.029	liter
Change From Baseline in Trough FEV1 (L) in Non-atopic Patients at Week 12 - Full Analysis Set	Placebo Non-atopic	0.03	Standard Error 0.029	liter
Change From Baseline in Trough FEV1 (L) in Atopic Patients at Week 12 - Full Analysis Set	QAW039 450 mg qd Atopic	0.06	Standard Error 0.038	liter
Change From Baseline in Trough FEV1 (L) in Atopic Patients at Week 12 - Full Analysis Set	Fluticasone 150 µg Bid Atopic	0.01	Standard Error 0.042	liter
Change From Baseline in Trough FEV1 (L) in Atopic Patients at Week 12 - Full Analysis Set	Placebo Atopic	0.05	Standard Error 0.037	liter
Change From Baseline in Trough FEV1 (L) in Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set	QAW039 450 mg qd Non-atopic	0.05	Standard Error 0.029	liter
Change From Baseline in Trough FEV1 (L) in Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set	Placebo Non-atopic	0.03	Standard Error 0.029	liter
Change From Baseline in Trough FEV1 (L) in Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set	QAW039 450 mg qd Atopic	0.06	Standard Error 0.038	liter
Change From Baseline in Trough FEV1 (L) in Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set	Fluticasone 150 µg Bid Atopic	0.01	Standard Error 0.042	liter
Change From Baseline in Trough FEV1 (L) in Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set	Placebo Atopic	0.05	Standard Error 0.037	liter

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	QAW039 450 mg qd Non-atopic	93
Overall Study	STARTED	Placebo Non-atopic	94
Overall Study	STARTED	QAW039 450 mg qd Atopic	51
Overall Study	STARTED	Fluticasone 150 µg Bid Atopic	42
Overall Study	STARTED	Placebo Atopic	54
Overall Study	COMPLETED	QAW039 450 mg qd Non-atopic	82
Overall Study	COMPLETED	Placebo Non-atopic	85
Overall Study	COMPLETED	QAW039 450 mg qd Atopic	49
Overall Study	COMPLETED	Fluticasone 150 µg Bid Atopic	40
Overall Study	COMPLETED	Placebo Atopic	49

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events114

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	DENTAL CARIES	Gastrointestinal disorders	QAW039 450 mg qd	0	145
other	DENTAL CARIES	Gastrointestinal disorders	Fluticasone 150 mcg Bid	1	42
other	DENTAL CARIES	Gastrointestinal disorders	Placebo	0	147
other	NAUSEA	Gastrointestinal disorders	QAW039 450 mg qd	1	145
other	NAUSEA	Gastrointestinal disorders	Fluticasone 150 mcg Bid	1	42
other	NAUSEA	Gastrointestinal disorders	Placebo	1	147
other	ACUTE SINUSITIS	Infections and infestations	QAW039 450 mg qd	0	145
other	ACUTE SINUSITIS	Infections and infestations	Fluticasone 150 mcg Bid	0	42
other	ACUTE SINUSITIS	Infections and infestations	Placebo	3	147
other	BRONCHITIS	Infections and infestations	QAW039 450 mg qd	3	145

1 to 10 of 114Source ClinicalTrials.gov

See all 114 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	QAW039 450 mg qd
Total, all-cause mortality	Fluticasone 150 mcg Bid
Total, all-cause mortality	Placebo
Total, other adverse events	QAW039 450 mg qd	36	145
Total, other adverse events	Fluticasone 150 mcg Bid	19	42
Total, other adverse events	Placebo	35	147
Total, serious adverse events	QAW039 450 mg qd	2	145
Total, serious adverse events	Fluticasone 150 mcg Bid	0	42
Total, serious adverse events	Placebo	3	147

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01836471

GET https://conductscience.org/api/trials/v1/NCT01836471/events?page=2

API reference For AI assistants