Asthma Clinical Trial
Official title:
A Phase II, Randomised, Double- Blind, Placebo Controlled, Cross-over Efficacy and Safety Comparison of Tiotropium 5 µg Administered Once Daily (in the Evening) and Tiotropium 2.5 µg Administered Twice Daily Delivered by the Respimat® Inhaler for Four Weeks Versus Placebo in Patients With Moderate Persistent Asthma
Rationale for the current trial is to demonstrate 24 hour bronchodilator efficacy and safety
of tiotropium 5 µg administered once daily (in the evening) which is regarded beneficial for
the compliance and convenience of the patient in comparison to placebo. Further the
rationale is to evaluate efficacy and safety of tiotropium 2.5 µg administered twice daily
delivered by the Respimat® inhaler in comparison to placebo and tiotropium 5 µg administered
once daily (in the evening) delivered by the Respimat® inhaler in patients with moderate
persistent asthma.
Rationale for the pharmacokinetic subinvestigation is to evaluate the 24 hours exposure to
tiotropium in patients with moderate persistent asthma when administered 5 µg tiotropium
once daily (in the evening) or 2.5 µg tiotropium twice daily.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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