Trial · NCT03052517
Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment
NCT03052517, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2020-10-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment. Trials, record NCT03052517. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03052517
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment
- NCT number
- NCT03052517
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 2,538 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Asthma
- Interventions
- QAW039 150 mg, QAW039 450 mg, Placebo
- First posted
- 2017-02-14
- Last updated
- 2020-10-12
- Other registries' IDs
- eudract:2016-001560-11
- Results first posted
- 2020-10-12
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 52 - Cox Regression Model | 52 weeks | Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs. For this Outcome Measure, AE up to week 52 are reported. |
| Primary | Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 156 - Cox Regression Model | 156 weeks | Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs |
| Primary | Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 52 - Cox Regression Model | 52 weeks | Serious Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +30 days were classified as treatment emergent SAEs. For this Outcome Measure, AE up to week 52 are reported. |
| Primary | Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 156 - Cox Regression Model | 156 weeks | Serious Adverse events starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +30 days were classified as treatment emergent SAEs. |
| Primary | Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 52 - Cox Regression Model | 52 weeks | Adverse events leading to study treatment discontinuation starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs leading to study treatment discontinuation. For this Outcome Measure, AE up to week 52 are reported. |
| Primary | Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 156 - Cox Regression Model | 156 weeks | Adverse events leading to study treatment discontinuation starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) were classified as treatment emergent AEs leading to study treatment discontinuation |
| Secondary | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | 52 weeks | The number of patients per patient year of follow-up having a treatment emergent adverse event, categorized by system organ class. Treatment emergent adverse events are defined as an AEs starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) |
| Secondary | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | 156 weeks | The number of patients per patient year of follow-up having a treatment emergent adverse event, categorized by system organ class. Treatment emergent adverse events are defined as an AEs starting on or after the day of the first intake of study drug in this study and until the day of last intake of study drug +7 days (30 days in the case of a serious AE) |
| Secondary | Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 52 | 52 weeks | The number of treatment emergent patient deaths due to an asthma exacerbation. Treatment emergent deaths are defined as deaths resulting from treatment emergent AEs. |
| Secondary | Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 156 | 156 weeks | The number of treatment emergent patient deaths due to an asthma exacerbation. Treatment emergent deaths are defined as deaths resulting from treatment emergent AEs. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 52 - Cox Regression Model | 52 weeks | Safety analysis set (SAF): included all patients who received at least one dose of study drug during this study. Patients were analyzed according to the treatment they received during this study. Only patients with data for all terms in the Cox regression model were included | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 156 - Cox Regression Model | 156 weeks | Safety analysis set (SAF): included all patients who received at least one dose of study drug during this study. Patients were analyzed according to the treatment they received during this study. Only patients with data for all terms in the Cox regression model were included | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 52 - Cox Regression Model | 52 weeks | Safety analysis set (SAF): included all patients who received at least one dose of study drug during this study. Patients were analyzed according to the treatment they received during this study. Only patients with data for all terms in the Cox regression model were included | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 156 - Cox Regression Model | 156 weeks | Safety analysis set (SAF): included all patients who received at least one dose of study drug during this study. Patients were analyzed according to the treatment they received during this study. Only patients with data for all terms in the Cox regression model were included | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 52 - Cox Regression Model | 52 weeks | Safety analysis set (SAF): included all patients who received at least one dose of study drug during this study. Patients were analyzed according to the treatment they received during this study. Only patients with data for all terms in the Cox regression model were included | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment Emergent AEs Leading to Discontinuation From Study Treatment up to Week 156 - Cox Regression Model | 156 weeks | Safety analysis set (SAF): included all patients who received at least one dose of study drug during this study. Patients were analyzed according to the treatment they received during this study. Only patients with data for all terms in the Cox regression model were included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 52 - Logistic Regression Model | 52 weeks | Safety analysis set (SAF): included all patients who received at least one dose of study drug during this study. Patients were analyzed according to the treatment they received during this study. Only patients with data for all terms in the Logistic regression model were included | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With at Least One Treatment Emergent AE by Primary System Organ Class up to Week 156 - Logistic Regression Model | 156 weeks | Safety analysis set (SAF): included all patients who received at least one dose of study drug during this study. Patients were analyzed according to the treatment they received during this study. Only patients with data for all terms in the Logistic regression model were included. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 52 | 52 weeks | Safety analysis set (SAF): included all patients who received at least one dose of study drug during this study. Patients were analyzed according to the treatment they received during this study. | Number of deaths | NUMBER |
| SECONDARY | Number of Treatment Emergent Patient Deaths Due to an Asthma Exacerbation up to Week 156 | 156 weeks | Safety analysis set (SAF): included all patients who received at least one dose of study drug during this study. Patients were analyzed according to the treatment they received during this study. | Number of deaths | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group189
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 52 - Cox Regression Model | QAW039 150mg | 675 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 52 - Cox Regression Model | QAW039 450 mg | 654 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 52 - Cox Regression Model | Placebo | 237 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 156 - Cox Regression Model | QAW039 150mg | 709 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 156 - Cox Regression Model | QAW039 450 mg | 681 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (AEs) up to Week 156 - Cox Regression Model | Placebo | 243 | Participants | ||
| Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 52 - Cox Regression Model | QAW039 150mg | 73 | Participants | ||
| Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 52 - Cox Regression Model | QAW039 450 mg | 53 | Participants | ||
| Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 52 - Cox Regression Model | Placebo | 29 | Participants | ||
| Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) up to Week 156 - Cox Regression Model | QAW039 150mg | 86 | Participants |
1 to 10 of 189Source ClinicalTrials.gov
See all 189 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | QAW039 150mg | 1,093 | |
| Overall Study | STARTED | QAW039 450 mg | 1,085 | |
| Overall Study | STARTED | Placebo | 360 | |
| Overall Study | Safety Set (SAF) | QAW039 150mg | 1,092 | |
| Overall Study | Safety Set (SAF) | QAW039 450 mg | 1,084 | |
| Overall Study | Safety Set (SAF) | Placebo | 361 | |
| Overall Study | COMPLETED | QAW039 150mg | 76 | |
| Overall Study | COMPLETED | QAW039 450 mg | 71 | |
| Overall Study | COMPLETED | Placebo | 32 | |
| Overall Study | NOT COMPLETED | QAW039 150mg | 1,017 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events468
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 | 75 | 1,092 | |
| other | Bronchitis | Infections and infestations | QAW039 450 mg | 55 | 1,084 | |
| other | Bronchitis | Infections and infestations | Placebo | 38 | 361 | |
| other | Influenza | Infections and infestations | QAW039 150 mg | 30 | 1,092 | |
| other | Influenza | Infections and infestations | QAW039 450 mg | 28 | 1,084 | |
| other | Influenza | Infections and infestations | Placebo | 9 | 361 | |
| other | Nasopharyngitis | Infections and infestations | QAW039 150 mg | 110 | 1,092 | |
| other | Nasopharyngitis | Infections and infestations | QAW039 450 mg | 106 | 1,084 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 36 | 361 | |
| other | Pharyngitis | Infections and infestations | QAW039 150 mg | 34 | 1,092 |
1 to 10 of 468Source ClinicalTrials.gov
See all 468 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | QAW039 150 mg | 3 | 1,092 |
| Total, all-cause mortality | QAW039 450 mg | 1 | 1,084 |
| Total, all-cause mortality | Placebo | 1 | 361 |
| Total, other adverse events | QAW039 150 mg | 525 | 1,092 |
| Total, other adverse events | QAW039 450 mg | 499 | 1,084 |
| Total, other adverse events | Placebo | 190 | 361 |
| Total, serious adverse events | QAW039 150 mg | 87 | 1,092 |
| Total, serious adverse events | QAW039 450 mg | 64 | 1,084 |
| Total, serious adverse events | Placebo | 33 | 361 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34895218 | 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/NCT03052517
GET https://conductscience.org/api/trials/v1/NCT03052517/results?page=2