Modification Of Disease Outcome In COPD

• Status: Terminated
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The hypothesis to be tested of this study is that treatment with fluticasone propionate leads to an initial improvement in symptoms, quality of life and lungfunction and a reduction in airways hyperresponsiveness. The continued decline of lungfunction in COPD may not be influenced by longer lasting treatment. Addition of salmeterol will augment the initial benefits of fluticasone without changing the longterm decline in lungfunction.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leiden University Medical Center
• Collaborators: Academisch Ziekenhuis Groningen; GlaxoSmithKline; Netherlands Organisation for Scientific Research; The Netherlands Asthma Foundation
• Treatments: Fluticasone; Salmeterol Xinafoate; Xhance

Criteria

Inclusion criteria:

• COPD patients with > 10 pack years.

• Written informed consent.

• Able to complete a diary card.

• At least one of the following symptoms: chronic cough, chronic sputum production, frequent exacerbations, or dyspnoea at exertion.

• Postbronchodilator FEV1 below 90% confidence interval of predicted and postbronchodilator FEV1/FVC below 90% confidence interval of predicted.

Exclusion criteria:

• No oral corticosteroids 3 months prior to the study or maintenance treatment with corticostroids 6 months prior to the study.

• No history of asthma, lung diseases other than COPD, other diseases likely to interfere with the study.