Asthma Clinical Trial
Official title:
A Phase II Randomised, Double-blind, Placebo Controlled, Cross-over Efficacy and Safety Comparison of Three Doses of Tiotropium Inhalation Solution Delivered Via Respimat Inhaler (1.25, 2.5 and 5.0 Mcg Once Daily) Versus Placebo in Patients With Moderate Persistent Asthma.
Rationale for the current trial is to evaluate the efficacy and safety of three doses (1.25
µg, 2.5 µg and 5.0 µg ex mouthpiece) of tiotropium inhalation solution in patients with
moderate persistent asthma who are still symptomatic despite regular maintenance therapy
with inhaled corticosteroids (ICS).
The data collected in the present trial will provide useful information to health care
providers and patients regarding the efficacy and safety of a once daily inhalation of three
different doses of tiotropium solution delivered by the Respimat® inhaler in addition to
inhaled corticosteroids in the treatment of not fully controlled moderate asthma in
comparison to placebo. The Pharmacokinetics (PK) of tiotropium is well established in COPD
patients. However, there is currently no PK data available for the 3 doses of tiotropium
being tested in this trial in patients with moderate persistent asthma. Tiotropium is a once
daily drug. Hence, the rationale for blood and urine sampling for PK analysis over 24 hours
in a subset of patients is to confirm the PK of the 3 doses in moderate asthma patients.
Rationale for the 24-hour pulmonary function test sub-investigation is to demonstrate that a
once daily dosing of tiotropium inhalation solution is effective and safe in the treatment
of moderate persistent asthma.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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