Macrolide Maintenance Therapy in Chronic Obstructive Pulmonary Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-06-30

Brief Summary

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To assess whether maintenance treatment with macrolide antibiotics in COPD patients with three or more exacerbations in the preceding year of inclusion can decrease the exacerbation rate in the year of treatment.

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Detailed Description

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COPD is characterized by progressive development of airflow limitation that is poorly reversible. Because of a poor understanding of COPD pathogenesis, treatment is mostly symptomatic and new therapeutic strategies are limited. There is a direct relationship between the severity of the disease and the intensity of the inflammatory response.One of the hypothesis for persistent airway inflammation is that the presence of recurrent infections is responsible for this condition.

Macrolide antibiotics have a bacteriostatic as well as anti-inflammatory properties. This clinical trial will investigate whether maintenance treatment with macrolide antibiotics during 1 year in people with 3 or more exacerbations in the preceding year of inclusion can decrease the exacerbation rate in that same year of treatment.

Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Azithromycin

Subjects in this group will receive 3 times a week 500 mg of the antibiotic azithromycin

Group Type ACTIVE_COMPARATOR

Azithromycin

Intervention Type DRUG

Subjects in this group will receive 3 times a week 500 mg of the antibiotic azithromycin during 1 year.

Placebo

Subjects in this group will receive 3 times a week placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Persons in this group will receive 3 times a week placebo of azithromycin during 1 year.

Interventions

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Azithromycin

Subjects in this group will receive 3 times a week 500 mg of the antibiotic azithromycin during 1 year.

Intervention Type DRUG

Placebo

Persons in this group will receive 3 times a week placebo of azithromycin during 1 year.

Intervention Type DRUG

Other Intervention Names

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Zithromax Azitrocin Ultreon Azadose Sumamed Azacleus Nuzaca Toraseptol Vinzam Zentavion

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of COPD according to GOLD criteria (FEV1/FVC\<70%), classification into GOLD I (FEV1 70-100% predicted), GOLD II (FEV1 50-70% predicted), GOLD III (FEV1 30- 50% predicted) or GOLD IV (FEV1 ≤ 30% predicted)
* Age ≥ 18 years
* Three or more exacerbations of COPD in one year for which a course of prednisone and/or antibiotic therapy was started
* Clinically stable during 1 month. Patients have to be free of COPD exacerbation or respiratory tract infection within a month prior to involvement in the study and they should not have received a high dose of systemic glucocorticoids or antibiotics in this period
* Informed consent

Exclusion Criteria

* Use of antibiotics or high dose of systemic steroids within a month prior to involvement in the study.
* Addition of inhalation steroids to the patient's therapy regimen, shortly before entering the study.
* Pregnant or lactating women.
* Allergy to macrolides.
* Liver disease (alanine transaminase and/or aspartate transaminase levels 2 or more times the upper limit of normal).
* Asthma, defined as episodic symptoms of airflow obstruction which is reversible with bronchodilators, assessed with lung function testing.
* Presence of a malignancy which is clinically active.
* Bronchiectasis.
* Malignancy of any kind for which the subject is under treatment or is being monitored as part of follow up after treatment.
* Heart failure.
* Use of drugs which can adversely interact with macrolides and for which therapeutic monitoring cannot be undertaken.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No