Defining long-term macrolide maintenance therapy in COPD: a single center randomized controlled trial:

Phase 4

• Conditions: chronic bronchitis; emphysema; 10038716

• Registration Number: NL-OMON49192
• Lead Sponsor: Amphia Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

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

Inclusion Criteria

COPP patients with azithromycin maintenance therapy for at least 12 months and
who have a stable exacerbation rate (2 or less exacerbations a year).
The initial indication for azithromycin maintenance therapy is frequent
exacerbations (3 or more exacerbations a year)

Exclusion Criteria

Bronchiectasis
Asthma
Antibiotics and prednisolon treatment because of an exacerbation in the last
month
prednisolone maintenance more than 5mg a day

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>time to first exacerbation of COPD, measured from the time of randomization </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>improvement of quality of life by Saint George*s Respiratory Questionnaire;<br /><br>pulmonary function (FEV1)<br /><br>frequency of exacerbation requiring an intervention with systemic<br /><br>corticosteroids and antibiotics (oral/intravenous [i.v.]) in subjects with<br /><br>COPD.<br /><br>microbiology of sputum production<br /><br>safety and tolerability of long term azithromycin<br /><br>inflammatory response measured by the following inflammatory markers:<br /><br>high-sensitivity C-reactive protein, the erythrocyte sedimentation rate,<br /><br>polymorphonuclear leukocytes, neutrophils; eosinophils; interleukin-6,<br /><br>interleukin-8, and myeloperoxidase;</p><br>