BI 671800 ED in Steroid-naive Asthmatic Patients
- Conditions
- Asthma
- Interventions
- Drug: BI 671800 Placebo
- Registration Number
- NCT01092143
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 389
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 671800 (low dose) BI 671800 Patients receive BI 671800 (low dose) capsules twice daily BI 671800 (low dose) Fluticasone propionate placebo Patients receive BI 671800 (low dose) capsules twice daily Fluticasone propionate BI 671800 Placebo Patients inhale from Fluticasone propionate metered dose inhaler (MDI) twice daily Placebo BI 671800 Placebo Patients receive placebo capsules twice daily BI 671800 (medium dose) BI 671800 Patients receive BI 671800 (medium dose) capsules twice daily BI 671800 (medium dose) Fluticasone propionate placebo Patients receive BI 671800 (medium dose) capsules twice daily BI 671800 (high dose) BI 671800 Patients receive BI 671800 (high dose) capsules twice daily BI 671800 (high dose) Fluticasone propionate placebo Patients receive BI 671800 (high dose) capsules twice daily Placebo Fluticasone propionate placebo Patients receive placebo capsules twice daily Fluticasone propionate Fluticasone propionate Patients inhale from Fluticasone propionate metered dose inhaler (MDI) twice 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 Score Change 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 (92)
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
Scroll for more (82 remaining)1268.17.01043 Boehringer Ingelheim Investigational Site🇺🇸Tucson, Arizona, United States