Comparison of Tiotropium in the HandhiHaler Versus the Respimat in Chronic Obstructive Pulmonary Disease



Status:Archived
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:May 2010

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A Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Design, Multi-center Trial to Compare the Efficacy and Safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution Delivered by the Respimat Inhaler With Tiotropium Inhalation Capsules 18 µg Delivered by the HandiHaler


Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg
formulations have been limited to 4-week crossover studies. Therefore, prospective data
from a trial of adequate size and duration is required to establish that compared to
tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b)
similar or superior effects on exacerbations.



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