The aim of the study is to establish the olodaterol dose in the ethanolic fixed dose combination (FDC) with BI 54903 which is equivalent in bronchodilator effect and systemic exposure to the 5 µg olodaterol reference dose in the aqueous inhalation solution (AIS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
1249.7.33003 Boehringer Ingelheim Investigational Site
Gières, France
FEV1 (AUC0-12h) FEV1 = Forced expiratory volume in one second, AUC = area under the curve
Time frame: 12 hours
FEV1 (AUC0-24h)
Time frame: 24 hours
FEV1 (AUC12-24h)
Time frame: 12 hours
Peak FEV1
Time frame: 12 hours
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aqueous and ethanolic solution
aqueous and ethanolic solution
aqueous and ethanolic solution
aqueous and ethanolic solution
aqueous solution
aqueous solution
aqueous solution
aqueous solution
aqueous solution
aqueous solution
aqueous solution
ethanolic solution
ethanolic solution
ethanolic solution
ethanolic solution
ethanolic solution
ethanolic solution
ethanolic solution
ethanolic solution
ethanolic solution
ethanolic solution
ethanolic solution
ethanolic solution
ethanolic solution
ethanolic solution