Determining the optimal duration of long-term macrolide antibiotics treatment in COPD with a single center randomized controlled study

Phase 1

• Conditions: Chronic obstructive pulmonary diseaseCOPD; MedDRA version: 21.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855; MedDRA version: 21.1Level: LLTClassification code 10010953Term: COPD exacerbationSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-004178-24-NL
• Lead Sponsor: Amphia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-09
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

COPP patients with azithromycin maintenance therapy for at least 12 montsh and who have a stable exacerbation rate (2 or less exacerbations a year).
The initial indication for azithromycin maintenance therapy should be frequent exacerbations (>3 exacerbations a year)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To evaluate the improvement of quality of life by Saint George’s Respiratory Questionnaire; <br>·To evaluate pulmonary function (FEV1) <br>·To evaluate the frequency of exacerbation requiring an intervention with systemic corticosteroids and antibiotics (oral/intravenous [i.v.]) in subjects with COPD. <br>·To assess the microbiology of sputum production<br>·To assess the safety and tolerability of long term azithromycin<br>·To assess the inflammatory response measured by the following inflammatory markers: high-sensitivity C-reactive protein, the erythrocyte sedimentation rate, polymorphonuclear leukocytes, neutrophils; eosinophils; interleukin-6, interleukin-8, and myeloperoxidase;<br>;Primary end point(s): Time to first exacerbation;Timepoint(s) of evaluation of this end point: end of the study;Main Objective: To assess the time to first exacerbation of COPD, measured from the time of randomization

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Quality of life<br>Lungfunction parameters<br>Exacerbation frequency<br>Sputum microbiology<br>Systemic inflammation<br>Safety of prolonged azithromycin usage;Timepoint(s) of evaluation of this end point: end of study