The aim of the study is to assess and compare efficacy and safety of BI 54903 at three different dosages (b.i.d)., fluticasone propionate hydrofluoroalkane (HFA) metered dose inhaler (MDI) at a dose of 440 mcg b.i.d and low dose fluticasone propionate 88 mcg b.i.d. over an 8-week treatment period in asthmatic patients aged 12 to 65 years inadequately controlled medium dose ICS therapy as demonstrated by a decrease in forced expiratory volume in one second (FEV1) range 10 to 25 % and an asthma control questionnaire-6 (ACQ-6) equal or greater than 1.5 at time of randomisation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
9
Placebo matching fluticasone propionate HFA MDI
Fluticasone propionate HFA MDI
BI 54903 via Respimat inhaler
1248.7.01047 Boehringer Ingelheim Investigational Site
Fountain Valley, California, United States
1248.7.01023 Boehringer Ingelheim Investigational Site
Fullerton, California, United States
1248.7.01038 Boehringer Ingelheim Investigational Site
Long Beach, California, United States
1248.7.01004 Boehringer Ingelheim Investigational Site
Mission Viejo, California, United States
1248.7.01028 Boehringer Ingelheim Investigational Site
Palmdale, California, United States
Mean Change From Randomisation Baseline to the End of the 8-week Treatment Period in Trough (Morning Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in One Second (FEV1)
Mean change from randomisation baseline to the end of the 8-week treatment period in trough (morning pre-dose and pre-rescue bronchodilator) Forced expiratory volume in one second (FEV1).
Time frame: At baseline and week 8
Mean Changes From Randomization Baseline in Trough (Morning Pre-dose and Pre-rescue Bronchodilator) Forced Vital Capacity (FVC) After 2, 4 and 8-week Treatment Periods
Mean changes from randomization baseline in trough (morning pre-dose and pre-rescue bronchodilator) forced vital capacity (FVC) after 2, 4 and 8-week treatment periods.
Time frame: At baseline and week 2, 4, 8.
Mean Changes From Randomization Baseline in Trough (Morning Pre-dose and Pre-rescue Bronchodilator) FEV1 After 2 and 4-week Treatment Periods
Mean changes from randomization baseline in trough (morning pre-dose and pre-rescue bronchodilator) FEV1 after 2 and 4-week treatment periods.
Time frame: At baseline and week 2 and 4.
Mean Pre-dose (and Pre-rescue) Peak Expiratory Flow (PEF) as Assessed Via Asthma Monitor2+ (AM2+) in the Morning and Evening of the Last Week of the 8-week Treatment Period
Mean pre-dose (and pre-rescue) peak expiratory flow (PEF) as assessed via Asthma Monitor2+ (AM2+) in the morning and evening of the last week of the 8-week treatment period.
Time frame: At week 8.
Mean Rescue Medication Use (Daytime and Night-time) as Assessed Via 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 AM2+ in the morning and evening of the last week of the 8-week treatment period.
Time frame: At week 8.
Mean Change From Randomisation Baseline in ACQ-6 Scores at Subsequent Study Visits
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.
Time frame: At baseline and week 2, 4, 8.
Mean Change From Randomisation Baseline in Asthma Quality of Life Questionnaire (AQLQ(S)+12) Scores at Subsequent Study Visits
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 frame: At baseline and week 2, 4, 8.
Time to Withdrawal Due to First Asthma Exacerbation
Time to withdrawal due to first asthma exacerbation.
Time frame: At week 8.
Mean Change From Randomization Baseline in Through (Morning Pre-dose and Pre-rescue Bronchodilator) FEF 25-75 After 2, 4 and 8-week Treatment Periods
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.
Time frame: At baseline and week 2, 4 and 8.
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1248.7.01044 Boehringer Ingelheim Investigational Site
Stockton, California, United States
1248.7.01015 Boehringer Ingelheim Investigational Site
Centennial, Colorado, United States
1248.7.01035 Boehringer Ingelheim Investigational Site
Aventura, Florida, United States
1248.7.01022 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
1248.7.01051 Boehringer Ingelheim Investigational Site
Columbus, Georgia, United States
...and 27 more locations