Trial Outcomes & Findings for A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™) (NCT NCT05865886)
NCT ID: NCT05865886
Last Updated: 2025-11-18
Results Overview
Occurrence of any treatment emergent adverse events is expressed as percentages of participants with treatment emergent adverse events. Percentages are rounded to one decimal place.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Results posted on
2025-11-18
Participant Flow
This was a randomised, double-blind, placebo-controlled, parallel group trial evaluating safety, tolerability, pharmacodynamics and pharmacokinetics of BI 1291583 one tablet once daily over 12 weeks versus placebo in adult patients with cystic fibrosis bronchiectasis (Clairafly™).
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Placebo
Participants with cystic fibrosis bronchiectasis administered orally once daily tablets of placebo matching BI 1291583 for 12 weeks.
|
5 mg BI 1291583
Participants with cystic fibrosis bronchiectasis administered orally once daily 5 milligram (mg) tablets of BI 1291583 for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
15
|
|
Overall Study
COMPLETED
|
7
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Participants with cystic fibrosis bronchiectasis administered orally once daily tablets of placebo matching BI 1291583 for 12 weeks.
|
5 mg BI 1291583
Participants with cystic fibrosis bronchiectasis administered orally once daily 5 milligram (mg) tablets of BI 1291583 for 12 weeks.
|
|---|---|---|
|
Overall Study
Serious adverse event
|
0
|
1
|
Baseline Characteristics
A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)
Baseline characteristics by cohort
| Measure |
Placebo
n=7 Participants
Participants with cystic fibrosis bronchiectasis administered orally once daily tablets of placebo matching BI 1291583 for 12 weeks.
|
5 mg BI 1291583
n=15 Participants
Participants with cystic fibrosis bronchiectasis administered orally once daily 5 milligram (mg) tablets of BI 1291583 for 12 weeks.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.4 years
STANDARD_DEVIATION 9.4 • n=202 Participants
|
32.3 years
STANDARD_DEVIATION 11.0 • n=283 Participants
|
32.4 years
STANDARD_DEVIATION 10.3 • n=120 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=202 Participants
|
5 Participants
n=283 Participants
|
9 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=202 Participants
|
10 Participants
n=283 Participants
|
13 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=202 Participants
|
1 Participants
n=283 Participants
|
1 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=202 Participants
|
14 Participants
n=283 Participants
|
21 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=202 Participants
|
15 Participants
n=283 Participants
|
22 Participants
n=120 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
PRIMARY outcome
Timeframe: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.Population: Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
Occurrence of any treatment emergent adverse events is expressed as percentages of participants with treatment emergent adverse events. Percentages are rounded to one decimal place.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants with cystic fibrosis bronchiectasis administered orally once daily tablets of placebo matching BI 1291583 for 12 weeks.
|
BI 1291583 5 mg
n=15 Participants
Participants with cystic fibrosis bronchiectasis administered orally once daily 5 milligram (mg) tablets of BI 1291583 for 12 weeks.
|
|---|---|---|
|
Occurrence of Any Treatment Emergent Adverse Events
|
85.7 Percentage of participants
|
93.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Before the first drug administration (baseline: mean value of screening and Week 0 prior to the first treatment intake) and Week 8 after first study drug administration.Population: Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment. Only participants with a value at baseline and at Week 8 are reported.
Relative change from baseline in neutrophil elastase (NE) activity, in sputum, at Week 8 after first drug administration is reported. Relative change from baseline at Week 8 in neutrophil elastase was calculated as below: Relative fluorescence unit (RFU) at Week 8-Relative fluorescence unit at baseline)\*100%/Relative fluorescence unit at baseline.
Outcome measures
| Measure |
Placebo
n=7 Participants
Participants with cystic fibrosis bronchiectasis administered orally once daily tablets of placebo matching BI 1291583 for 12 weeks.
|
BI 1291583 5 mg
n=13 Participants
Participants with cystic fibrosis bronchiectasis administered orally once daily 5 milligram (mg) tablets of BI 1291583 for 12 weeks.
|
|---|---|---|
|
Relative Change From Baseline in NE Activity, in Sputum, at Week 8 After First Drug Administration
|
39.69 percent change in RFU
Standard Deviation 134.67
|
-65.95 percent change in RFU
Standard Deviation 49.37
|
SECONDARY outcome
Timeframe: Before drug administration and 1 hour (h), 3.5h, 6h after administration of the first dose of BI 1291583 at Day 1.Population: Pharmacokinetic set (PKS): This patient set included all patients from the treated set (TS) who provided at least one post-dose plasma BI 1291583 concentration that was not excluded due to a protocol deviation relevant to the evaluation of pharmacokinetic (PK), or due to PK non-evaluability.
Area under the curve of BI 1291583 in plasma over a uniform dosing interval tau=6h after the first dose (AUC0-6) is reported.
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants with cystic fibrosis bronchiectasis administered orally once daily tablets of placebo matching BI 1291583 for 12 weeks.
|
BI 1291583 5 mg
Participants with cystic fibrosis bronchiectasis administered orally once daily 5 milligram (mg) tablets of BI 1291583 for 12 weeks.
|
|---|---|---|
|
Area Under the Curve of BI 1291583 in Plasma Over a Uniform Dosing Interval Tau=6h After the First Dose (AUC0-6)
|
14.0 hours *nanomole/Liter (h*nmol/L)
Geometric Coefficient of Variation 65.3
|
—
|
SECONDARY outcome
Timeframe: Before drug administration at Day 85 and 1 hour (h), 3.5h, 6h after administration of BI 1291583 at Day 85.Population: Pharmacokinetic set (PKS): This patient set included all patients from the treated set (TS) who provided at least one post-dose plasma BI 1291583 concentration that was not excluded due to a protocol deviation relevant to the evaluation of pharmacokinetic (PK), or due to PK non-evaluability. Only participants with evaluable results for this PK parameter are reported.
Area under the curve of BI 1291583 in plasma over a uniform dosing interval tau=6h at steady state (AUC0-6,ss) is reported.
Outcome measures
| Measure |
Placebo
n=8 Participants
Participants with cystic fibrosis bronchiectasis administered orally once daily tablets of placebo matching BI 1291583 for 12 weeks.
|
BI 1291583 5 mg
Participants with cystic fibrosis bronchiectasis administered orally once daily 5 milligram (mg) tablets of BI 1291583 for 12 weeks.
|
|---|---|---|
|
Area Under the Curve of BI 1291583 in Plasma Over a Uniform Dosing Interval Tau=6h at Steady State (AUC0-6,ss)
|
65.9 hours *nanomole/Liter (h*nmol/L)
Geometric Coefficient of Variation 64.5
|
—
|
SECONDARY outcome
Timeframe: Before drug administration and 1 hour (h), 3.5h, 6h, and 8h after administration of the first dose of BI 1291583 at Day 1.Population: Pharmacokinetic set (PKS): This patient set included all patients from the treated set (TS) who provided at least one post-dose plasma BI 1291583 concentration that was not excluded due to a protocol deviation relevant to the evaluation of pharmacokinetic (PK), or due to PK non-evaluability.
Maximum measured concentration of BI 1291583 in plasma after the first dose is reported.
Outcome measures
| Measure |
Placebo
n=15 Participants
Participants with cystic fibrosis bronchiectasis administered orally once daily tablets of placebo matching BI 1291583 for 12 weeks.
|
BI 1291583 5 mg
Participants with cystic fibrosis bronchiectasis administered orally once daily 5 milligram (mg) tablets of BI 1291583 for 12 weeks.
|
|---|---|---|
|
Maximum Measured Concentration of BI 1291583 in Plasma After the First Dose
|
3.33 nmol/L
Geometric Coefficient of Variation 74.4
|
—
|
SECONDARY outcome
Timeframe: Before drug administration at Day 85 and 1 hour (h), 3.5h, 6h after administration of BI 1291583 at Day 85.Population: Pharmacokinetic set (PKS): This patient set included all patients from the treated set (TS) who provided at least one post-dose plasma BI 1291583 concentration that was not excluded due to a protocol deviation relevant to the evaluation of pharmacokinetic (PK), or due to PK non-evaluability. Only participants with evaluable results for this PK parameter are reported.
Maximum measured concentration of BI 1291583 in plasma at steady state is reported.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants with cystic fibrosis bronchiectasis administered orally once daily tablets of placebo matching BI 1291583 for 12 weeks.
|
BI 1291583 5 mg
Participants with cystic fibrosis bronchiectasis administered orally once daily 5 milligram (mg) tablets of BI 1291583 for 12 weeks.
|
|---|---|---|
|
Maximum Measured Concentration of BI 1291583 in Plasma at Steady State
|
11.6 nmol/L
Geometric Coefficient of Variation 69.9
|
—
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
5 mg BI 1291583
Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=7 participants at risk
Participants with cystic fibrosis bronchiectasis administered orally once daily tablets of placebo matching BI 1291583 for 12 weeks.
|
5 mg BI 1291583
n=15 participants at risk
Participants with cystic fibrosis bronchiectasis administered orally once daily 5 milligram (mg) tablets of BI 1291583 for 12 weeks.
|
|---|---|---|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
6.7%
1/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
14.3%
1/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
6.7%
1/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
20.0%
3/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Seizure
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
6.7%
1/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
Other adverse events
| Measure |
Placebo
n=7 participants at risk
Participants with cystic fibrosis bronchiectasis administered orally once daily tablets of placebo matching BI 1291583 for 12 weeks.
|
5 mg BI 1291583
n=15 participants at risk
Participants with cystic fibrosis bronchiectasis administered orally once daily 5 milligram (mg) tablets of BI 1291583 for 12 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
1/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
6.7%
1/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
6.7%
1/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
6.7%
1/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Eye disorders
Conjunctivitis allergic
|
14.3%
1/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
28.6%
2/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Enteritis
|
14.3%
1/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Gastrointestinal disorders
Gingival recession
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
6.7%
1/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Hepatobiliary disorders
Hepatic fibrosis
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
6.7%
1/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
6.7%
1/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
14.3%
1/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
26.7%
4/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
13.3%
2/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Otitis externa
|
14.3%
1/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Pneumonia
|
14.3%
1/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Pneumonia viral
|
14.3%
1/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
6.7%
1/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Infections and infestations
Sputum purulent
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
6.7%
1/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
6.7%
1/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
6.7%
1/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Investigations
Forced expiratory volume decreased
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
13.3%
2/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
6.7%
1/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
6.7%
1/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
6.7%
1/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
6.7%
1/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
13.3%
2/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
6.7%
1/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Nervous system disorders
Sleep deficit
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
6.7%
1/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
28.6%
2/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
1/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
6.7%
1/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
6.7%
1/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
14.3%
1/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
0.00%
0/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
6.7%
1/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/7 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
13.3%
2/15 • All-Cause Mortality, Serious Adverse Events and other adverse events: From first dose of trial drug administration until last dose of trial drug administration plus 28 days of residual effect period, up to 16 weeks.
Treated Set (TS): included all randomised patients who were documented to have taken at least one dose of investigational treatment.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER