Trial · NCT02563067
Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
NCT02563067, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2021-05-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment. Trials, record NCT02563067. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02563067
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
- NCT number
- NCT02563067
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 877 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Asthma
- Interventions
- QAW039, QAW039, Placebo
- First posted
- 2015-09-29
- Last updated
- 2021-05-03
- Other registries' IDs
- eudract:2015-003172-67
- Results first posted
- 2021-05-03
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in High Eosinophils Subpopulation | 52 weeks | A severe asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and hospitalization; or treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and emergency department visit (greater than 24 hours\*); or death due to asthma. A moderate asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days either as an outpatient or in emergency department visits (Emergency department visit less than or equal to 24 hours). The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline. |
| Primary | Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in Overall Population | 52 weeks | A severe asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and hospitalization; or treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and emergency department visit (greater than 24 hours\*); or death due to asthma. A moderate asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days either as an outpatient or in emergency department visits (Emergency department visit less than or equal to 24 hours). |
| Secondary | Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in High Eosinophils Subpopulation | Baseline, Week 52 | 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. The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline. |
| Secondary | Change From Baseline to Week 52 in Asthma Control Questionnaire-5 (ACQ-5) Score in High Eosinophils Subpopulation | Baseline, Week 52 | The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. The ACQ-5 score is the average of the individual item scores and ranges from 0 to 6. Higher scores indicates worsening of condition. The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline. |
| Secondary | Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in High Eosinophils Subpopulation | Baseline, Week 52 | 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. The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline. |
| Secondary | Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in Overall Population | Baseline, Week 52 | 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. |
| Secondary | Change From Baseline to Week 52 in Asthma Control Questionnaire-5 (ACQ-5) Score in Overall Population | Baseline, Week 52 | The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. The ACQ-5 score is the average of the individual item scores and ranges from 0 to 6. Higher scores indicates worsening of condition. |
| Secondary | Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in Overall Population | Baseline, Week 52 | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in High Eosinophils Subpopulation | 52 weeks | Full Analysis Set (FAS) in high eosinophils subpopulation (count ≥ 250 cells/μL) | Events/year | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in High Eosinophils Subpopulation | Baseline, Week 52 | Full Analysis Set (FAS) in high eosinophils subpopulation (count ≥ 250 cells/μL) | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 52 in Asthma Control Questionnaire-5 (ACQ-5) Score in High Eosinophils Subpopulation | Baseline, Week 52 | Full Analysis Set (FAS) in high eosinophils subpopulation (count ≥ 250 cells/μL) | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in High Eosinophils Subpopulation | Baseline, Week 52 | Full Analysis Set (FAS) in high eosinophils subpopulation (count ≥ 250 cells/μL) | Liter | LEAST_SQUARES_MEAN |
| PRIMARY | Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in Overall Population | 52 weeks | Full Analysis Set (FAS), including all randomized patients who received at least one dose of study drug. | Events/year | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in Overall Population | Baseline, Week 52 | Full Analysis Set (FAS), including all randomized patients who received at least one dose of study drug. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 52 in Asthma Control Questionnaire-5 (ACQ-5) Score in Overall Population | Baseline, Week 52 | Full Analysis Set (FAS), including all randomized patients who received at least one dose of study drug. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in Overall Population | Baseline, Week 52 | Full Analysis Set (FAS), including all randomized patients who received at least one dose of study drug. | Liter | LEAST_SQUARES_MEAN |
| POST_HOC | All Collected Deaths | up to 56 weeks | Safety Set (SAF), including all randomized patients who received at least one dose of study drug | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in High Eosinophils Subpopulation | QAW039 150 mg | 0.73 | 95% Confidence Interval 0.57 to 0.94 | Events/year | |
| Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in High Eosinophils Subpopulation | QAW039 450 mg | 0.76 | 95% Confidence Interval 0.59 to 0.99 | Events/year | |
| Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in High Eosinophils Subpopulation | Placebo | 1.06 | 95% Confidence Interval 0.84 to 1.33 | Events/year | |
| Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in High Eosinophils Subpopulation | QAW039 150 mg | 0.73 | Standard Error 0.061 | units on a scale | |
| Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in High Eosinophils Subpopulation | QAW039 450 mg | 0.71 | Standard Error 0.062 | units on a scale | |
| Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in High Eosinophils Subpopulation | Placebo | 0.58 | Standard Error 0.062 | units on a scale | |
| Change From Baseline to Week 52 in Asthma Control Questionnaire-5 (ACQ-5) Score in High Eosinophils Subpopulation | QAW039 150 mg | -0.92 | Standard Error 0.067 | units on a scale | |
| Change From Baseline to Week 52 in Asthma Control Questionnaire-5 (ACQ-5) Score in High Eosinophils Subpopulation | QAW039 450 mg | -0.84 | Standard Error 0.068 | units on a scale | |
| Change From Baseline to Week 52 in Asthma Control Questionnaire-5 (ACQ-5) Score in High Eosinophils Subpopulation | Placebo | -0.75 | Standard Error 0.069 | units on a scale | |
| Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in High Eosinophils Subpopulation | QAW039 150 mg | 0.192 | Standard Error 0.0306 | Liter |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | QAW039 150 mg | 296 | |
| Overall Study | STARTED | QAW039 450 mg | 294 | |
| Overall Study | STARTED | Placebo | 287 | |
| Overall Study | FAS/SAF: High Eosinophils Subpopulation | QAW039 150 mg | 198 | |
| Overall Study | FAS/SAF: High Eosinophils Subpopulation | QAW039 450 mg | 196 | |
| Overall Study | FAS/SAF: High Eosinophils Subpopulation | Placebo | 193 | |
| Overall Study | FAS/SAF: Overall Population | QAW039 150 mg | 296 | |
| Overall Study | FAS/SAF: Overall Population | QAW039 450 mg | 293 | |
| Overall Study | FAS/SAF: Overall Population | Placebo | 287 | |
| Overall Study | COMPLETED | QAW039 150 mg | 277 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events183
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 | Events |
|---|---|---|---|---|---|---|
| other | Bronchitis | Infections and infestations | QAW039 150 mg | 37 | 296 | |
| other | Bronchitis | Infections and infestations | QAW039 450 mg | 30 | 293 | |
| other | Bronchitis | Infections and infestations | Placebo | 32 | 287 | |
| other | Influenza | Infections and infestations | QAW039 150 mg | 17 | 296 | |
| other | Influenza | Infections and infestations | QAW039 450 mg | 18 | 293 | |
| other | Influenza | Infections and infestations | Placebo | 13 | 287 | |
| other | Nasopharyngitis | Infections and infestations | QAW039 150 mg | 33 | 296 | |
| other | Nasopharyngitis | Infections and infestations | QAW039 450 mg | 42 | 293 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 26 | 287 | |
| other | Rhinitis | Infections and infestations | QAW039 150 mg | 10 | 296 |
1 to 10 of 183Source ClinicalTrials.gov
See all 183 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | QAW039 150 mg | 0 | 296 |
| Total, all-cause mortality | QAW039 450 mg | 1 | 293 |
| Total, all-cause mortality | Placebo | 1 | 287 |
| Total, other adverse events | QAW039 150 mg | 181 | 296 |
| Total, other adverse events | QAW039 450 mg | 183 | 293 |
| Total, other adverse events | Placebo | 180 | 287 |
| Total, serious adverse events | QAW039 150 mg | 20 | 296 |
| Total, serious adverse events | QAW039 450 mg | 20 | 293 |
| Total, serious adverse events | Placebo | 18 | 287 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32979986 | DERIVED |
Source PubMed
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.
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/NCT02563067
GET https://conductscience.org/api/trials/v1/NCT02563067/results?page=2