Study on BI 54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Low Dose Inhaled Corticosteroid (ICS)
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT01397201
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The aim of the study is to assess and compare efficacy and safety of BI 54903 at 3 doses twice daily (b.i.d.), fluticasone propionate hydrofluoroalkane metered dose inhaler (HFA MDI) at a dose of 220 mcg b.i.d. and placebo b.i.d. over an 8-week treatment period in asthmatic patients aged 12 to 65 years inadequately controlled on low dose Inhaled corticosteroid (ICS) as demonstrated by a decrease in forced expiratory volume in one second (FEV1 (range 10-25%) and an asthma control questionnaire (ACQ-6) greater or equal 1.5 at time of randomisation
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 54903 - low dose BI 54903 Respimat inhaler containing low dose BI 54903 plus placebo matching hydrofluoralkane (HFA) metered dose inhaler (MDI) BI 54903 - low dose Placebo Respimat inhaler containing low dose BI 54903 plus placebo matching hydrofluoralkane (HFA) metered dose inhaler (MDI) BI 54903 - medium dose Placebo Respimat inhaler containing medium dose BI 54903 plus placebo matching HFA MDI BI 54903 - medium dose BI 54903 Respimat inhaler containing medium dose BI 54903 plus placebo matching HFA MDI BI 54903 - high dose Placebo Respimat inhaler containing high dose BI 54903 plus placebo matching HFA MDI BI 54903 - high dose BI 54903 Respimat inhaler containing high dose BI 54903 plus placebo matching HFA MDI Placebo Placebo Placebo matching Respimat inhaler plus placebo matching HFA MDI Fluticasone propionate Fluticasone propionate Fluticasone HFA MDI containing ICS plus placebo matching Respimat inhaler
- Primary Outcome Measures
Name Time Method Mean Change From Randomisation Baseline to the End of the 8-week Treatment Period in Trough (Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in One Second (FEV1) At baseline and at week 8. Mean change from randomisation baseline to the end of the 8-week treatment period in trough (pre-dose and pre-rescue bronchodilator) forced expiratory volume in one second (FEV1).
- Secondary Outcome Measures
Name Time Method Mean Changes From Randomisation Baseline in Trough (Morning Pre-dose and Pre-rescue Bronchodilator) FEF25-75 After 2, 4 and 8-week Treatment Periods At baseline and at week 2, 4 and 8. Mean change from randomization baseline in through (morning pre-dose and pre-rescue bronchodilator) Forced expiratory flow between 25% and 75% of vital capacity (FEF 25-75) after 2, 4 and 8-week treatment periods.
Mean Changes From Randomisation Baseline in Trough (Pre-dose and Pre-rescue Bronchodilator) Forced Vital Capacity (FVC) After 2, 4 and 8-week Treatment Periods At baseline and at week 2, 4 and 8. Mean changes from randomisation baseline in trough (pre-dose and pre-rescue bronchodilator) forced vital capacity (FVC) after 2, 4 and 8-week treatment periods.
Mean Changes From Randomisation Baseline in Trough (Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in One Second (FEV1) After 2 and 4-week Treatment Periods At baseline and at week 2 and 4. Mean changes from randomisation baseline in trough (pre-dose and pre-rescue bronchodilator) forced expiratory volume in one second (FEV1) after 2 and 4-week treatment periods.
Mean Pre-dose (and Pre-rescue) Peak Expiratory Flow (PEF) as Assessed Via Asthma Monitor (AM2+) in the Morning and Evening, of the Last Week of the 8-week Treatment Period 8 weeks Mean pre-dose (and pre-rescue) peak expiratory flow (PEF) as assessed via Asthma monitor (AM2+) in the morning and evening, of the last week of the 8-week treatment period.
Mean Rescue Medication Use (Daytime and Night-time) as Assessed Via Asthma Monitor (AM2+) in the Morning and Evening, of the Last Week of the 8-week Treatment Period At week 8. Mean rescue medication use (daytime and night-time) as assessed via asthma monitor (AM2+) in the morning and evening, of the last week of the 8-week treatment period.
Mean Change From Randomisation Baseline in Asthma Control Questionnaire (ACQ-6) Scores at Subsequent Study Visits At baseline and at week 2, 4 and 8. The Asthma Control Questionnaire (ACQ) consists of 6 patient self-evaluated questions with each question in 7-point scale. The items are equally weighted and the ACQ score is the mean of 6 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of less than or equal to 0.75 indicate well-controlled asthma, scores between 0.76 and less than 1.5 indicate partly controlled asthma, and a score greater than or equal to 1.5 indicates uncontrolled asthma.
Mean Change From Randomisation Baseline in Asthma Quality of Life Questionnaire (AQLQ(S)+12) Scores at Subsequent Study Visits At baseline and at week 2, 4 and 8. AQLQ(S)+12 are well established and validated questionnaires to measure control of asthma symptoms and quality of life, which is a patient-reported self-administered outcome questionnaire containing 32 items. Each item is scored on a 7-point scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.
Time to Withdrawal Due to First Asthma Exacerbation At week 8. Time to withdrawal due to first Asthma exacerbation.
Trial Locations
- Locations (41)
1248.6.01019 Boehringer Ingelheim Investigational Site
🇺🇸Baltimore, Maryland, United States
1248.6.01049 Boehringer Ingelheim Investigational Site
🇺🇸Berlin, New Jersey, United States
1248.6.01040 Boehringer Ingelheim Investigational Site
🇺🇸Pittsburgh, Pennsylvania, United States
1248.6.01035 Boehringer Ingelheim Investigational Site
🇺🇸Aventura, Florida, United States
1248.6.01052 Boehringer Ingelheim Investigational Site
🇺🇸Savannah, Georgia, United States
1248.6.01028 Boehringer Ingelheim Investigational Site
🇺🇸Palmdale, California, United States
1248.6.01037 Boehringer Ingelheim Investigational Site
🇺🇸Ypsilanti, Michigan, United States
1248.6.01055 Boehringer Ingelheim Investigational Site
🇺🇸Oak Lawn, Illinois, United States
1248.6.01004 Boehringer Ingelheim Investigational Site
🇺🇸Mission Viejo, California, United States
1248.6.01025 Boehringer Ingelheim Investigational Site
🇺🇸Murray, Utah, United States
1248.6.01013 Boehringer Ingelheim Investigational Site
🇺🇸Philadelphia, Pennsylvania, United States
1248.6.01036 Boehringer Ingelheim Investigational Site
🇺🇸Warrensburg, Missouri, United States
1248.6.01042 Boehringer Ingelheim Investigational Site
🇺🇸Sarasota, Florida, United States
1248.6.01056 Boehringer Ingelheim Investigational Site
🇺🇸Rolla, Missouri, United States
1248.6.01030 Boehringer Ingelheim Investigational Site
🇺🇸Tacoma, Washington, United States
1248.6.01011 Boehringer Ingelheim Investigational Site
🇺🇸Eagle, Idaho, United States
1248.6.01006 Boehringer Ingelheim Investigational Site
🇺🇸Rochester, New York, United States
1248.6.01010 Boehringer Ingelheim Investigational Site
🇺🇸Verona, New Jersey, United States
1248.6.01005 Boehringer Ingelheim Investigational Site
🇺🇸Gresham, Oregon, United States
1248.6.01053 Boehringer Ingelheim Investigational Site
🇺🇸Alexandria, Virginia, United States
1248.6.01001 Boehringer Ingelheim Investigational Site
🇺🇸Waco, Texas, United States
1248.6.01022 Boehringer Ingelheim Investigational Site
🇺🇸Miami, Florida, United States
1248.6.01021 Boehringer Ingelheim Investigational Site
🇺🇸Portland, Oregon, United States
1248.6.01046 Boehringer Ingelheim Investigational Site
🇺🇸San Antonio, Texas, United States
1248.6.01050 Boehringer Ingelheim Investigational Site
🇺🇸Austin, Texas, United States
1248.6.01047 Boehringer Ingelheim Investigational Site
🇺🇸Fountain Valley, California, United States
1248.6.01023 Boehringer Ingelheim Investigational Site
🇺🇸Fullerton, California, United States
1248.6.01038 Boehringer Ingelheim Investigational Site
🇺🇸Long Beach, California, United States
1248.6.01041 Boehringer Ingelheim Investigational Site
🇺🇸Huntington Beach, California, United States
1248.6.01044 Boehringer Ingelheim Investigational Site
🇺🇸Stockton, California, United States
1248.6.01015 Boehringer Ingelheim Investigational Site
🇺🇸Centennial, Colorado, United States
1248.6.01051 Boehringer Ingelheim Investigational Site
🇺🇸Columbus, Georgia, United States
1248.6.01039 Boehringer Ingelheim Investigational Site
🇺🇸North Dartmouth, Massachusetts, United States
1248.6.01054 Boehringer Ingelheim Investigational Site
🇺🇸Trenton, New Jersey, United States
1248.6.01045 Boehringer Ingelheim Investigational Site
🇺🇸Cincinnati, Ohio, United States
1248.6.01031 Boehringer Ingelheim Investigational Site
🇺🇸High Point, North Carolina, United States
1248.6.01012 Boehringer Ingelheim Investigational Site
🇺🇸Upland, Pennsylvania, United States
1248.6.01002 Boehringer Ingelheim Investigational Site
🇺🇸Live Oak, Texas, United States
1248.6.01034 Boehringer Ingelheim Investigational Site
🇺🇸Walnut Creek, California, United States
1248.6.01020 Boehringer Ingelheim Investigational Site
🇺🇸Omaha, Nebraska, United States
1248.6.01048 Boehringer Ingelheim Investigational Site
🇺🇸Charleston, South Carolina, United States