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®.

Boehringer Ingelheim Pharmaceuticals, Inc0 sites16,800 target enrollmentApril 8, 2010

Overview

No summary available.

Registry

who.int

Start Date

April 8, 2010

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. All patients must sign an informed consent consistent with ICH\-GCP guidelines
•prior to participation in the trial, includes medication washout and restrictions.
•2\. Male or female patients aged 40 years of age or over
•3\. Patients must be current or ex\-smokers with a smoking history of \=10 pack\-
•years. (Patients who have never smoked cigarettes must be excluded)
•4\. All patients must have a diagnosis of COPD and must meet the following
•Relatively stable airway obstruction with a post\-bronchodilator FEV1 \=70% of
•predicted normal and post\-bronchodilator FEV1 / FVC \=70%
•5\. Patients must be able to inhale from the HandiHaler® and the Respimat®
•Are the trial subjects under 18? no

•1\. Significant diseases other than COPD.
•2\. Patients with a recent history (i.e., six months or less) of myocardial infarction.
•3\. Patients with any unstable or life\-threatening cardiac arrhythmia requiring
•intervention or change in drug therapy during the last year.
•4\. Hospitalisation for cardiac failure (New York Heart Association (NYHA) Class III or
•IV) during the past year.
•5\. Known active tuberculosis.
•6\. Patients with a history of asthma, cystic fibrosis, bronchiectasis, interstitial lung
•disease, or pulmonary thromboembolic disease
•7\. A history of thoracotomy with pulmonary resection.