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)

Phase 4

Completed

• Conditions: dyspnoe; pulmonary disease; 10046304

• Registration Number: NL-OMON31594
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 64

Inclusion Criteria

Current or ex-smoker, 40 years of age or older, diagnosed with COPD with at least one exacerbation within the past year requiring treatment.
Patients must have a post-bronchodilator FEV1 <= 70% of predicted normal and FEV1 <= 70% of FVC post-bronchodilator.

Exclusion Criteria

Patients with cardiac-related conditions, significant diseases other than COPD and other concomitant conditions and therapies that will have an impact on the wellbeing of the patient or may influence either the result of the study or the patients' ability to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The Primary Endpoint is the time to first COPD exacerbation</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The Secondary Endpoints are:<br /><br>1. Occurrence of at least one exacerbation<br /><br>2. Number of COPD exacerbations<br /><br>3. Time to first hospitalisation due to COPD exacerbation<br /><br>4. Occurrence of at least one hospitalization due to COPD exacerbations<br /><br>5. Number of hospitalisations due to COPD exacerbations<br /><br>6. Time to premature discontinuation of trial medication<br /><br>7. Occurrence of premature discontinuation of trial medication<br /><br>8. Pre-dose morning PEFR measured by patients at home during the first four<br /><br>months of randomised treatment (weekly means will be calculated)<br /><br>9. Time to first COPD exacerbation or time to discontinuation of study<br /><br>medication because of worsening of underlying disease, whichever comes first</p><br>