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Clinical Trials/NCT00549445
NCT00549445CompletedNot Applicable

Effect of Macrolide Treatment on a Novel Pathway of Neutrophilic Inflammation in COPD

University of Alabama at Birmingham1 site in 1 country53 target enrollmentStarted: August 2007Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
53
Locations
1
Primary Endpoint
Levels of PGP From Sputum Samples of COPD Patients Being Treated With Azithromycin.

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Azithromycin-treated

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

Intervention: Azithromycin (Drug)

Placebo-treated

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

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Levels of PGP From Sputum Samples of COPD Patients Being Treated With Azithromycin.

Time Frame: Baseline to 12 months

Nasopharyngeal swabs were obtained to determine if there is a reduction in PGP levels (including both PGP \& Neutrophil-PGP) after chronic treatment with azithromycin. Unblinding of the parent trial revealed that there were 18 sputum samples from 13 placebo-treated participants and 14 sputum samples from 8 azithromycin-treated participants collected at months 1 through 12 of treatment (with sputum samples not being available, this greatly reduced the sample size).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

J Edwin Blalock

Professor, Medicine-Pulm/Allergy/Clinical

University of Alabama at Birmingham

Study Sites (1)

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