Finding studies
Finding studies
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Lead
Nephron Pharmaceuticals Corporation
With
Objectives: Primary: • To determine the effect of once daily dosing with tiotropium bromide inhalation solution for 22 consecutive days on trough forced expiratory volume in 1 second (FEV1) change from baseline compared with that of placebo inhalation solution in subjects with chronic obstructive pulmonary disease (COPD). Secondary: * To determine the effect of once daily dosing with tiotropium bromide inhalation solution for 22 consecutive days on trough FEV1 change from baseline compared with that of Spiriva Respimat; area under the curve (AUC) FEV10-6 change from baseline compared with that of placebo and Spiriva Respimat; and trough forced vital capacity (FVC) change from baseline compared with that of placebo and Spiriva Respimat * To assess the safety and tolerability of tiotropium bromide inhalation solution in subjects with COPD * To assess the relative bioavailability of tiotrop
Age
40–80
Sex
ALL
Healthy volunteers
Not accepted