Phase 2
N=243
BI 671800 in Asthmatic Patients on Inhaled Corticosteroids
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01103349 ↗Enrolled (actual)
243
Serious AEs
0.4%
Results posted
May 2022
Primary outcome: Primary: Forced Expiratory Volume in One Second (FEV1) % Predicted Trough Change From Baseline (Mean Observed in the 2 Weeks Prior to Treatment) After Six Weeks of Treatment — -0.859; 3.011; 1.510 FEV1 percent predicted — p=0.0050
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BI 671800 (Drug); Placebo (Drug); Montelukast (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Expiratory Volume in One Second (FEV1) % Predicted Trough Change From Baseline (Mean Observed in the 2 Weeks Prior to Treatment) After Six Weeks of Treatment |
-0.859; 3.011; 1.510 | 0.0050 sig |
| SECONDARY Asthma Control Questionnaire (ACQ) Mean Change in Score on a Scale From Baseline After Six Weeks of Treatment |
-0.418; -0.698; -0.598 | 0.0092 sig |
Summary
This is a 6 week study to assess the effect of BI 671800 in patients with asthma. It is a double blind, parallel arm trial testing the safety and efficacy of BI 671800. The main objective is to assess the effect on lung function. The study will also provide data on the pharmacokinetics of BI 671800.
Eligibility Criteria
Inclusion criteria
- Signed informed consent consistent with ICH-GCP
- Three month history of reversible (12% and 200 mL in forced expiratory volume in one second - FEV1) asthma (according to GINA) with following spirometry at randomisation: FEV1 60%- 85%.
- Stable inhaled corticosteroids (iCS) dose 3 months prior to screening.
- Diagnosis of asthma prior to 40 years.
- Asthma Control Questionnaire (ACQ) at least 1.5 at randomisation.
- Male or female 18 to 65 years.
- Non-smokers or ex-smokers (less than 10 pack years history) with negative cotinine screen.
- Able to perform pulmonary function testing.
Exclusion criteria
- Significant diseases other than asthma or allergic rhinitis.
- Hepatic transaminases or total bilirubin greater than 1.5 ULN.
- Hospitalisation for asthma exacerbation or asthma related intubation within 3 months.
- Uncontrolled asthma on iCS + other controller.
- Respiratory tract infection or exacerbation within 4 weeks.
- FEV1 less than 40%, more than 12 puffs rescue salbutamol on more than two consecutive days, or asthma exacerbation during run-in period.
- Participation in another interventional study.
- Pregnant or nursing women.
- Women of child bearing potential not using appropriate methods of birth control as defined by the study protocol.
Data sourced from ClinicalTrials.gov (NCT01103349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.