Trial · NCT03810183
A Proof-of-mechanism Study of Multiple, Oral Doses of Fevipiprant (QAW039) in COPD Patients With Eosinophilia
NCT03810183, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2021-01-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Proof-of-mechanism Study of Multiple, Oral Doses of Fevipiprant (QAW039) in COPD Patients With Eosinophilia. Trials, record NCT03810183. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03810183
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Proof-of-mechanism Study of Multiple, Oral Doses of Fevipiprant (QAW039) in COPD Patients With Eosinophilia
- NCT number
- NCT03810183
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- QAW039, Placebo
- First posted
- 2019-01-18
- Last updated
- 2021-10-08
- Other registries' IDs
- eudract:2018-004267-32
- Results first posted
- 2021-01-25
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Sputum Eosinophil Percentage Based on Log-10 Transformed Scale at Week 6 | Baseline, Week 6 | Sputum eosinophil percentage of the total cell count was obtained from induced sputum samples. Sputum was processed to include preparation of slides for differential cellular count. As sputum eosinophil percentage has been found to follow a log-normal distribution, the analysis of this outcome measure was based on log10-transformed scale. The baseline measurement was defined as sputum eosinophil percentage prior to the first dosing (on log10-transformed scale). |
Source ClinicalTrials.gov
Outcomes1
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 Sputum Eosinophil Percentage Based on Log-10 Transformed Scale at Week 6 | Baseline, Week 6 | All subjects with available data and no protocol deviations with relevant impact on data. | Percentage | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Sputum Eosinophil Percentage Based on Log-10 Transformed Scale at Week 6 | QAW039 450 mg | -0.43373 | Standard Deviation 0.39740 | Percentage | |
| Change From Baseline in Sputum Eosinophil Percentage Based on Log-10 Transformed Scale at Week 6 | Placebo | -0.06689 | Standard Deviation 0.43094 | Percentage |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | QAW039 450 mg | 6 | |
| Overall Study | STARTED | Placebo | 3 | |
| Overall Study | COMPLETED | QAW039 450 mg | 4 | |
| Overall Study | COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | QAW039 450 mg | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events24
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 | Nasopharyngitis | Infections and infestations | QAW039 450mg | 1 | 6 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 0 | 3 | |
| other | Nasopharyngitis | Infections and infestations | Total | 1 | 9 | |
| other | Fall | Injury, poisoning and procedural complications | QAW039 450mg | 0 | 6 | |
| other | Fall | Injury, poisoning and procedural complications | Placebo | 1 | 3 | |
| other | Fall | Injury, poisoning and procedural complications | Total | 1 | 9 | |
| other | Foot fracture | Injury, poisoning and procedural complications | QAW039 450mg | 1 | 6 | |
| other | Foot fracture | Injury, poisoning and procedural complications | Placebo | 1 | 3 | |
| other | Foot fracture | Injury, poisoning and procedural complications | Total | 2 | 9 | |
| other | Joint injury | Injury, poisoning and procedural complications | QAW039 450mg | 0 | 6 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | QAW039 450mg | 0 | 6 |
| Total, all-cause mortality | Placebo | 0 | 3 |
| Total, all-cause mortality | Total | 0 | 9 |
| Total, other adverse events | QAW039 450mg | 4 | 6 |
| Total, other adverse events | Placebo | 2 | 3 |
| Total, other adverse events | Total | 6 | 9 |
| Total, serious adverse events | QAW039 450mg | 0 | 6 |
| Total, serious adverse events | Placebo | 0 | 3 |
| Total, serious adverse events | Total | 0 | 9 |
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.
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/NCT03810183
GET https://conductscience.org/api/trials/v1/NCT03810183/events?page=2