The aim of this study is to assess and compare efficacy and safety of BI 54903 at medium doses twice daily and high doses once daily (evening dosing) and placebo over an 12-week treatment period in asthmatic patients aged 12 to 65 years inadequately controlled on low dose inhaled corticosteroid (ICS) therapy as demonstrated by a decrease in Forced Expiratory Volume in one second (FEV1) (not less than 10 %, and equal to or less than 25%) and an Asthma Control Questionnaire (ACQ)-6 score of not less than 1.5 at time of randomisation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
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Mean change from randomisation baseline to the end of the 12-week treatment period in evening trough (pre-dose and pre-rescue bronchodilator) FEV1
Time frame: 12 weeks
Mean change from randomisation baseline to the end of the 12-week treatment period in morning and evening trough (pre-dose and pre-rescue bronchodilator) Forced Vital Capacity (FVC)
Time frame: 12 weeks
Mean change from randomisation baseline in morning and evening trough (pre-dose and pre-rescue bronchodilator) FEV1 and FVC after 2, 4 and 8-week treatment periods, and in morning trough FEV1 after 12 week treatment period
Time frame: 12 weeks
Mean pre-dose (and pre-rescue) Peak Expiratory Flow (PEF) as assessed via Asthma Monitor2+ (AM2+) device (in the morning and evening) of the last week of the 12-week treatment period
Time frame: 12 weeks
Mean rescue medication use (daytime and night-time) as assessed via AM2+ device (in the morning and evening) of the last week of the 12-week treatment period
Time frame: 12 weeks
Asthma control questionnaire (ACQ-6).
Time frame: 12 weeks
Asthma quality of life questionnaire (AQLQ(S)+12)
Time frame: 12 weeks
Time to withdrawal due to first asthma exacerbation
Time frame: 12 weeks
Daytime 12-h FEV1 profiles after 12-week treatment period (FEV1 Area Under Curve (AUC) 0-12h)
Time frame: 12 weeks
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