The Effect of Azithromycin in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Productive Cough

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate the efficacy of azithromycin to produce a significant change in the cough-related health status, measured with the Dutch version of the Leicester Cough Questionnaire in patiënts with COPD gold classification 2-4 and chronic productive coughing.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Isala
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

• Patients > 40 years of age, in our outpatient clinic with chronic cough and COPD (gold2-4)

• Chronic cough is defined as a cough > 12 weeks duration, at least 12 weeks a year in 2 subsequent years.

• Analysed for bronchiectasis prior to participation by CT-thorax.

Exclusion Criteria:

• Prior history of asthma

• Use of i.v. or oral corticosteroids and or antibiotics for an exacerbation 3 weeks before inclusion

• Patients suffering from other relevant lung diseases.

• Clinically relevant abnormal laboratory values suggesting an unknown disease requiring further clinical evaluation.

• Liver disease, (ALAT and/or ASAT levels two or more times the upper limit of normal).

• Pregnancy or lactation.

• Use of macrolides the last 6 weeks prior to inclusion.

• Allergy or intolerance to macrolides.

• Other research medication started 2 months prior to inclusion.

• Prior randomisation in this study.