Official Title: “Effect of Inhalation of Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients (a Randomized, Double-Blind, Double-Dummy, Parallel Group, One-Year Study).”

The primary objective of this study is to compare the effect of tiotropium (18 mcg) inhalation capsule via HandiHaler and salmeterol (50 mcg) via MDI on COPD exacerbations.

Study Type: Interventional

Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2010

Intervention(s) in this Clinical Trial

• Drug: Tiotropium bromide
  • 18 mcg/daily
• Drug: Salmeterol
  • 100 mcg/daily

Primary Measures

• The primary endpoint is the time to first COPD exacerbation.
  • Time Frame: 52 weeks
    

Secondary Measures

• 1. Occurrence of at least one exacerbation 2. Number of COPD exacerbations 3. Time to first hospitalisation due to COPD exacerbation 4. Number of hospitalisations due to COPD exacerbations
  • Time Frame: 52 weeks
    

Inclusion Criteria:

• 1. All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) and must meet the following criteria at Visit 1: Patients must have relatively stable, moderate to very severe airway obstruction with a post-bronchodilator FEV1 <= 70% of predicted normal and FEV1 <= 70% of FVC post-bronchodilator (i.e. 30 minutes after inhalation of 4 puffs of 100 mcg salbutamol or equivalent SABA).
• 3. Male or female patients 40 years of age or older. 4. Patients with a history of at least one exacerbation within the past year requiring treatment with either antibiotics and/or steroids and/or hospitalisation.

Exclusion Criteria:

• 1. Significant diseases other than COPD. 2. Patients with a diagnosis of asthma.
• 5. Patients with a known symptomatic prostatic hyperplasia or bladder neck obstruction.
• 6. Patients with known narrow-angle glaucoma. 7. Patients with a history of myocardial infarction within the year prior to Visit 1.
• 8. Patients with a history of hospital admission for heart failure within the year prior to Visit 1.
• 9. Patients with cardiac arrhythmia requiring medical or surgical treatment. 18. Use of systemic corticosteroid medication at unstable doses 22. Patients with any respiratory infection or COPD exacerbation in the four weeks prior to the Screening Visit (Visit 1) or during the run-in period should be postponed.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Overall Contact: Boehringer Ingelheim Study Coordinator  clintriage@boehringer-ingelheim.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00563381

Study ID Number: 205.389

ClinicalTrials.gov Identifier: NCT00563381

Health Authority: Germany: BfArM (Bundesinstitut fur Arzneimittel und Medizinalprodukte)