The purpose of this study is to confirm equivalent bronchodilator efficacy of the test product compared to the reference product.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
72
Specialized Hospital for Active Treatment for Pneumophthisiatric Diseases Dr Dimitar Gramatikov-Ruse EOOD
Rousse, Bulgaria
Average FEV1
FEV1 determined from serial spirometry and calculated on the basis of area under the curve
Time frame: 12 h
Maximum FEV1
Maximum FEV1 over the 12-hour serial assessments
Time frame: 12 h
FEV1 at 12 h
FEV1 at 12 hours post-dose
Time frame: 12 h
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