The aim of this study is to assess and compare efficacy and safety of BI 54903 at doses of very low dose twice daily (b.i.d) and low dose once daily (evening dosing) and placebo over an 12-week treatment period in asthmatic patients aged 12 to 65 years inadequately controlled on short acting beta-2 agonist (SABA) therapy alone as demonstrated by a decrease in forced expiratory volume in 1 second (FEV1) (not less than 10 %, and equal to or less than 25%) and an Asthma Control Questionnaire (ACQ-6) of not less than 1.5 at time of randomisation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
2 puffs b.i.d. via Respimat inhaler
2 puffs a.m. via Respimat inhaler
2 puffs a.m. via Respimat inhaler
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) 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) PEF as assessed via 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: 12weeks
Daytime 12-h FEV1 profiles after 12-week treatment period (FEV1 AUC0-12h)
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
2 puffs LD b.i.d. via Respimat inhaler
Mean change from randomisation baseline in morning and evening trough (pre-dose and pre-rescue bronchodilator) FEF25-75 after 2, 4, 8 and 12 week treatment periods
Time frame: 2, 4, 8 and 12 weeks