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®.
- Conditions
- chronic obstructive pulmonary diseaseCOPD10038716
- Registration Number
- NL-OMON36382
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
1.All patients must sign an informed consent consistent with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
2.Male or female patients 40 years of age or older.
3.Patients must be current or ex-smokers with a smoking history of >=10 pack-years.
4.All patients must have a diagnosis of COPD (according to definition in protocol page 26)
5.Patients must be able to inhale from the HandiHaler® and the Respimat® devices.
1.Significant diseases other than COPD. (see protocl for definitions)
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. A respiratory infection or exacerbation of COPD in the four weeks prior to screening.
6. Patients with a history of asthma, cystic fibrosis, bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease
7. Use of systemic corticosteroid medication at unstable doses (i.e., less than six weeks on stable dose) or at doses in excess of the equivalent of 10 milligrams (mg) prednisolone per day
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints:<br /><br>- Time to death (all-cause mortality)<br /><br>- Time to first COPD exacerbation</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br /><br>- Number of COPD exacerbations<br /><br>- Time to first hospitalisation due to COPD exacerbation<br /><br>- Number of hospitalisations due to COPD exacerbations<br /><br>- Time to first major adverse cardiovascular event</p><br>