EUCTR2009-015713-51-NL
Active, not recruiting
Phase 1
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®. - TIOSPIR
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic obstructive pulmonary disease (COPD)
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 16800
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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