BI 671800 in Asthmatic Patients on Inhaled Corticosteroids
- Registration Number
- NCT01103349
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 243
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 671800 BI 671800 Patients receive BI 671800 capsules twice daily Placebo Placebo Patients receive placebo capsules and/or encapsulated placebo tablets Montelukast Montelukast Patients receive Montelukast encapsulated tablets once daily
- Primary Outcome Measures
Name Time Method 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 Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment. Forced expiratory volume in one second (FEV1) % predicted trough change from baseline (mean observed in the 2 weeks prior to treatment) after 6 weeks of treatment, where trough FEV1 % predicted was defined as the mean of the FEV1 % predicted trough values at 25 minutes and 10 minutes prior to dosing on clinic visit.
MMRM in the statistical test comments is Mixed effects model with repeated measures.
- Secondary Outcome Measures
Name Time Method Asthma Control Questionnaire (ACQ) Mean Change in Score on a Scale From Baseline After Six Weeks of Treatment Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment. Asthma Control Questionnaire (ACQ) mean score change from baseline (mean ACQ score obtained at Week 0) after six weeks of treatment.
The Asthma Control Questionnaire (ACQ) is a patient-reported outcome questionnaire containing 7 items. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore between 0 (well controlled) and 6 (extremely poorly controlled) These questions based on recall of the previous 7 days comprise breathlessness, nocturnal waking, symptoms on waking, activity limitation, wheeze, frequency of Short-acting beta-adrenergic (SABA) use, and categorized pre-bronchodilator FEV1% predicted.
Trial Locations
- Locations (53)
1268.16.01004 Boehringer Ingelheim Investigational Site
🇺🇸Denver, Colorado, United States
1268.16.01001 Boehringer Ingelheim Investigational Site
🇺🇸North Dartmouth, Massachusetts, United States
1268.16.01006 Boehringer Ingelheim Investigational Site
🇺🇸Plymouth, Minnesota, United States
1268.16.01003 Boehringer Ingelheim Investigational Site
🇺🇸Portland, Oregon, United States
1268.16.01002 Boehringer Ingelheim Investigational Site
🇺🇸Charleston, South Carolina, United States
1268.16.01005 Boehringer Ingelheim Investigational Site
🇺🇸El Paso, Texas, United States
1268.16.43002 Boehringer Ingelheim Investigational Site
🇦🇹Feldbach, Austria
1268.16.49018 Boehringer Ingelheim Investigational Site
🇩🇪Aschaffenburg, Germany
1268.16.49014 Boehringer Ingelheim Investigational Site
🇩🇪Bamberg, Germany
1268.16.49001 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany
Scroll for more (43 remaining)1268.16.01004 Boehringer Ingelheim Investigational Site🇺🇸Denver, Colorado, United States