Asthma Clinical Trial
Official title:
A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (5 mcg/Day) Over 48 Weeks as add-on Controller Therapy on Top of Usual Care in Patients With Severe Persistent Asthma
The trial is a randomised, double-blind, placebo-controlled, parallel-group trial to
evaluate the efficacy and safety of 5 µg tiotropium over a 48-week treatment period as
compared to placebo. Tiotropium inhalation solution delivered by the Respimat® inhaler will
be examined as add-on controller therapy on top of usual care in patients with severe
persistent asthma.
The primary objective of each trial is to evaluate the long term efficacy of tiotropium over
placebo on top of usual care in patients with severe persistent asthma as determined by
pulmonary function testing, effects on asthma exacerbations, effects on quality of life, on
asthma control and health care resource utilisation. The secondary objective of each trial
is to compare the long term safety of tiotropium with placebo in this patient population.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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