This is a 6 week study to investigate the effectiveness and safety of BI 671800 ED in patients with asthma who do not take inhaled corticosteroids.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
389
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 Score Change 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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Placebo matching BI 671800
1268.17.01043 Boehringer Ingelheim Investigational Site
Tucson, Arizona, United States
1268.17.01009 Boehringer Ingelheim Investigational Site
Cypress, California, United States
1268.17.01006 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1268.17.01040 Boehringer Ingelheim Investigational Site
Palmdale, California, United States
1268.17.01024 Boehringer Ingelheim Investigational Site
San Jose, California, United States
1268.17.01003 Boehringer Ingelheim Investigational Site
Stockton, California, United States
1268.17.01015 Boehringer Ingelheim Investigational Site
Colorado Springs, Colorado, United States
1268.17.01001 Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
1268.17.01016 Boehringer Ingelheim Investigational Site
Lakewood, Colorado, United States
1268.17.01033 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
...and 82 more locations