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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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
205.420.43002 Boehringer Ingelheim Investigational Site
Linz, Austria
205.420.43004 Boehringer Ingelheim Investigational Site
Schlüsslberg, Austria
205.420.43003 Boehringer Ingelheim Investigational Site
Thalheim bei Wels, Austria
205.420.43001 Boehringer Ingelheim Investigational Site
Wels, Austria
205.420.42002 Boehringer Ingelheim Investigational Site
Brno, Czechia
205.420.42001 Boehringer Ingelheim Investigational Site
Kyjov, Czechia
205.420.37201 Boehringer Ingelheim Investigational Site
Kohtla-Järve, Estonia
205.420.37202 Boehringer Ingelheim Investigational Site
Tallinn, Estonia
205.420.49002 Boehringer Ingelheim Investigational Site
Großhansdorf, Germany
205.420.49004 Boehringer Ingelheim Investigational Site
Hanover, Germany
Start Date
July 1, 2010
Primary Completion Date
August 1, 2011
Last Updated
December 19, 2024
94
ACTUAL participants
Tiotropium 2.5 µg b.i.d
DRUG
Placebo
DRUG
Tiotropium 5 µg q.d.
DRUG
Lead Sponsor
Boehringer Ingelheim
Collaborators
NCT02327897
NCT07219173
NCT07486401
Data Source & Attribution
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