Trial · NCT03226392

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

NCT03226392, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2020-02-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma. Trials, record NCT03226392. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03226392

On this page

Trial

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

Title: Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma
NCT number: NCT03226392
Status: Completed
Phases: Phase 3
Enrollment: 704 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Asthma
Interventions: QAW039, Placebo
First posted: 2017-07-21
Last updated: 2026-01-13
Other registries' IDs: eudract:2017-001272-40
Results first posted: 2020-02-28

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	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	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.
Secondary	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.
Secondary	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.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Pre-dose FEV1	Baseline and Week 12	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.	Liters	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Daytime Asthma Symptom Score	Baseline and Week 12	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.	Score	LEAST_SQUARES_MEAN
SECONDARY	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)	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.	Puffs per day	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ+12) Score	Baseline and Week 12	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.	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Change From Baseline in Pre-dose FEV1	QAW039	0.126	Standard Error 0.00177	Liters
Change From Baseline in Pre-dose FEV1	Placebo	0.157	Standard Error 0.0177	Liters
Change From Baseline in Daytime Asthma Symptom Score	QAW039	-0.55	Standard Error 0.034	Score
Change From Baseline in Daytime Asthma Symptom Score	Placebo	-0.45	Standard Error 0.034	Score
Change From Baseline in Number of Puffs of SABA Taken Per Day	QAW039	-0.89	Standard Error 0.066	Puffs per day
Change From Baseline in Number of Puffs of SABA Taken Per Day	Placebo	-0.88	Standard Error 0.066	Puffs per day
Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ+12) Score	QAW039	0.77	Standard Error 0.043	units on a scale
Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ+12) Score	Placebo	0.72	Standard Error 0.043	units on a scale

Source ClinicalTrials.gov

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	QAW039	352
Overall Study	STARTED	Placebo	352
Overall Study	FAS	QAW039	352
Overall Study	FAS	Placebo	350
Overall Study	COMPLETED	QAW039	341
Overall Study	COMPLETED	Placebo	344
Overall Study	NOT COMPLETED	QAW039	11
Overall Study	NOT COMPLETED	Placebo	8

Source ClinicalTrials.gov

Adverse events54

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	Bronchitis	Infections and infestations	QAW039 150 mg	9	352
other	Bronchitis	Infections and infestations	Placebo	6	350
other	Influenza	Infections and infestations	QAW039 150 mg	4	352
other	Influenza	Infections and infestations	Placebo	1	350
other	Nasopharyngitis	Infections and infestations	QAW039 150 mg	10	352
other	Nasopharyngitis	Infections and infestations	Placebo	24	350
other	Pharyngitis	Infections and infestations	QAW039 150 mg	5	352
other	Pharyngitis	Infections and infestations	Placebo	2	350
other	Respiratory tract infection viral	Infections and infestations	QAW039 150 mg	5	352
other	Respiratory tract infection viral	Infections and infestations	Placebo	1	350

1 to 10 of 54Source ClinicalTrials.gov

See all 54 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	QAW039 150 mg	0	352
Total, all-cause mortality	Placebo	0	350
Total, other adverse events	QAW039 150 mg	94	352
Total, other adverse events	Placebo	116	350
Total, serious adverse events	QAW039 150 mg	7	352
Total, serious adverse events	Placebo	3	350

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 comparisons2

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

Comparison	Source
QAW039 150 mg vs Placebo: deaths from any cause	Trial comparisons
QAW039 150 mg vs Placebo: serious adverse events	Trial comparisons

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/NCT03226392

GET https://conductscience.org/api/trials/v1/NCT03226392/events?page=2

API reference For AI assistants