Trial Outcomes & Findings for A Proof-of-mechanism Study of Multiple, Oral Doses of Fevipiprant (QAW039) in COPD Patients With Eosinophilia (NCT NCT03810183)
NCT ID: NCT03810183
Last Updated: 2021-10-08
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Baseline, Week 6
Results posted on
2021-10-08
Participant Flow
Participants took part in 4 investigative sites in 2 countries (Germany and United Kingdom).
Participants were randomized 3:2 to active (QAW039 450 mg orally daily) vs. placebo arms. Randomization was stratified by current smoking status (current vs. ex-smoker).
Participant milestones
| Measure |
QAW039 450 mg
QAW039 (fevipiprant) 450 mg once daily for 6 weeks administered orally as a tablet.
|
Placebo
Placebo once daily for 6 weeks administered orally as a tablet.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
|
Overall Study
COMPLETED
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
QAW039 450 mg
QAW039 (fevipiprant) 450 mg once daily for 6 weeks administered orally as a tablet.
|
Placebo
Placebo once daily for 6 weeks administered orally as a tablet.
|
|---|---|---|
|
Overall Study
Study terminated by Sponsor
|
2
|
1
|
Baseline Characteristics
A Proof-of-mechanism Study of Multiple, Oral Doses of Fevipiprant (QAW039) in COPD Patients With Eosinophilia
Baseline characteristics by cohort
| Measure |
QAW039 450 mg
n=6 Participants
QAW039 (fevipiprant) 450 mg once daily for 6 weeks administered orally as a tablet.
|
Placebo
n=3 Participants
Placebo once daily for 6 weeks administered orally as a tablet.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.5 Years
STANDARD_DEVIATION 9.71 • n=5 Participants
|
67.3 Years
STANDARD_DEVIATION 6.35 • n=7 Participants
|
64.8 Years
STANDARD_DEVIATION 8.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: All subjects with available data and no protocol deviations with relevant impact on data.
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).
Outcome measures
| Measure |
QAW039 450 mg
n=3 Participants
QAW039 (fevipiprant) 450 mg once daily for 6 weeks administered orally as a tablet.
|
Placebo
n=2 Participants
Placebo once daily for 6 weeks administered orally as a tablet.
|
|---|---|---|
|
Change From Baseline in Sputum Eosinophil Percentage Based on Log-10 Transformed Scale at Week 6
|
-0.43373 Percentage
Standard Deviation 0.39740
|
-0.06689 Percentage
Standard Deviation 0.43094
|
Adverse Events
QAW039 450mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Total
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
QAW039 450mg
n=6 participants at risk
QAW039 (fevipiprant) 450 mg once daily for 6 weeks administered orally as a tablet.
|
Placebo
n=3 participants at risk
Placebo once daily for 6 weeks administered orally as a tablet.
|
Total
n=9 participants at risk
Total
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Adverse events were collected from first dose of study treatment until last dose plus 30 days, up to a maximum of 72 days.
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment until last dose plus 30 days, up to a maximum of 72 days.
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
11.1%
1/9 • Adverse events were collected from first dose of study treatment until last dose plus 30 days, up to a maximum of 72 days.
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until last dose plus 30 days, up to a maximum of 72 days.
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
33.3%
1/3 • Adverse events were collected from first dose of study treatment until last dose plus 30 days, up to a maximum of 72 days.
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
11.1%
1/9 • Adverse events were collected from first dose of study treatment until last dose plus 30 days, up to a maximum of 72 days.
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
16.7%
1/6 • Adverse events were collected from first dose of study treatment until last dose plus 30 days, up to a maximum of 72 days.
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
33.3%
1/3 • Adverse events were collected from first dose of study treatment until last dose plus 30 days, up to a maximum of 72 days.
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
22.2%
2/9 • Adverse events were collected from first dose of study treatment until last dose plus 30 days, up to a maximum of 72 days.
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until last dose plus 30 days, up to a maximum of 72 days.
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
33.3%
1/3 • Adverse events were collected from first dose of study treatment until last dose plus 30 days, up to a maximum of 72 days.
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
11.1%
1/9 • Adverse events were collected from first dose of study treatment until last dose plus 30 days, up to a maximum of 72 days.
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Adverse events were collected from first dose of study treatment until last dose plus 30 days, up to a maximum of 72 days.
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment until last dose plus 30 days, up to a maximum of 72 days.
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
11.1%
1/9 • Adverse events were collected from first dose of study treatment until last dose plus 30 days, up to a maximum of 72 days.
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Adverse events were collected from first dose of study treatment until last dose plus 30 days, up to a maximum of 72 days.
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment until last dose plus 30 days, up to a maximum of 72 days.
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
11.1%
1/9 • Adverse events were collected from first dose of study treatment until last dose plus 30 days, up to a maximum of 72 days.
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
16.7%
1/6 • Adverse events were collected from first dose of study treatment until last dose plus 30 days, up to a maximum of 72 days.
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment until last dose plus 30 days, up to a maximum of 72 days.
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
11.1%
1/9 • Adverse events were collected from first dose of study treatment until last dose plus 30 days, up to a maximum of 72 days.
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment until last dose plus 30 days, up to a maximum of 72 days.
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
33.3%
1/3 • Adverse events were collected from first dose of study treatment until last dose plus 30 days, up to a maximum of 72 days.
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
11.1%
1/9 • Adverse events were collected from first dose of study treatment until last dose plus 30 days, up to a maximum of 72 days.
Any signs or symptoms that occurs during study treatment plus the 30 days post treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER