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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
243
Double blind randomised parallel group study to assess efficacy and tolerability of BI 617800 in patients with symptomatic asthma
Patients receive placebo capsules and/or encapsulated tablets
Double blind randomised parallel group study to assess efficacy and tolerability of BI 671800 in patients with symptomatic asthma
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
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.
Time frame: Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment.
Asthma Control Questionnaire (ACQ) Mean Change in Score on a Scale From Baseline After Six Weeks 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.
Time frame: Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment.
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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
...and 43 more locations