The objective of this study is to compare the bronchodilator efficacy a of tiotropium inhalation via DISCAIR (18 mcg once daily) and SPIRIVA HANDIHALER® (18 mcg once daily) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
tiotropium 18 mcg once a day
Median maximum change (ml) from baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC)
Time frame: prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose
Percantage (%) change from baseline in FEV1 and FVC
Time frame: prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose
Standardized Area Under the Curve (AUC) Between Baseline (Pre-dose) and 24 Hours -Post-dose
Time frame: Baseline FEV1 taken at visit 2 prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose
- Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 - 24h (AUC 0-24) Response
Time frame: Baseline FEV1 taken at visit 2 prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose
Time to onset of bronchodilator effect and maximum effect
Time frame: 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose
Adverse Events
Time frame: predose and up to 24 hours postdose
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