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Effect of Macrolide Antibiotics on Airway Inflammation in People With Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT00549445

Last Updated: 2017-09-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2012-07-31

Brief Summary

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Chronic obstructive pulmonary disease (COPD) is a chronic lung disease. Azithromycin, an antibiotic, may be beneficial at reducing the symptoms and severity of the disease. This study will analyze previously collected study data to evaluate the anti-inflammatory properties of azithromycin and determine how azithromycin affects the frequency and severity of COPD exacerbations.

Detailed Description

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COPD is a disease in which the lung airways are partly damaged and obstructed, making it difficult to breathe. The most common cause is cigarette smoking, but breathing in other types of lung irritants, including pollution, dust, and chemicals, over a long period of time may also contribute to COPD. It is the fourth leading cause of death in the United States. Symptoms include coughing, excess mucus production, shortness of breath, wheezing, and chest tightness.

Some bacterial infections may worsen COPD exacerbations. Current studies are examining if the macrolide antibiotic azithromycin may be beneficial at reducing the frequency and/or severity of COPD exacerbations. Azithromycin also has anti-inflammatory properties that may reduce the severity of COPD exacerbations by inhibiting the matrix metalloprotease (MMP)-catalyzed breakdown of collagen and the subsequent generation of proline-glycine-proline (PGP), a substance produced in response to collagen breakdown. An increase in PGP levels may indicate an increase in inflammation, which can worsen COPD symptoms. NHLBI's COPD Network Macrolide study includes people with COPD who were randomly assigned to receive either azithromycin or placebo for 1 year. For this current study, researchers will examine the Macrolide participants' previously collected blood samples, sputum samples, and study data, including information on COPD exacerbations and azithromycin effects. The purpose of this study is to examine the anti-inflammatory properties of azithromycin in people with COPD.

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Azithromycin-treated

Participants in the COPD Network Macrolide Study who received azithromycin for 1 year.

Azithromycin

Intervention Type DRUG

250 mg daily

Placebo-treated

Participants in the COPD Network Macrolide Study who received placebo for 1 year.

Placebo

Intervention Type DRUG

Daily

Interventions

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Azithromycin

250 mg daily

Intervention Type DRUG

Placebo

Daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participating in the COPD Network Macrolide study
* Clinical diagnosis of at least moderate COPD
* Cigarette consumption of 10 pack years or more

Exclusion Criteria

* Diagnosis of asthma
* Predicted life expectancy of less than 3 years
* History of hypersensitivity to macrolide antibiotics
* Long-term kidney insufficiency
* Long-term liver insufficiency
* Prolonged QT interval
* Use of medications that may prolong the QT interval
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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J Edwin Blalock

Professor, Medicine-Pulm/Allergy/Clinical

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James E. Blalock, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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R01HL090999-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HL090999-01

Identifier Type: -

Identifier Source: secondary_id

1425

Identifier Type: -

Identifier Source: org_study_id