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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
J Edwin Blalock, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00549445
First received: October 24, 2007
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Pulmonary Disease, Chronic Obstructive
Drug: Azithromycin
Drug: Placebo

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effect of Macrolide Treatment on a Novel Pathway of Neutrophilic Inflammation in COPD

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Time to first COPD exacerbation [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Alteration in levels of PGP and matrix metalloprotease (MMP) in blood and sputum [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum and Plasma


Enrollment: 53
Study Start Date: August 2007
Study Completion Date: July 2012
Groups/Cohorts Assigned Interventions
Azithromycin-treated
Participants in the COPD Network Macrolide Study who received azithromycin for 1 year.
Drug: Azithromycin
250 mg daily
Placebo-treated
Participants in the COPD Network Macrolide Study who received placebo for 1 year.
Drug: Placebo
Daily

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 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549445

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: James E. Blalock, PhD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: J Edwin Blalock, Professor, Medicine-Pulm/Allergy/Clinical, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00549445     History of Changes
Other Study ID Numbers: 1425, R01HL090999-01, HL090999-01
Study First Received: October 24, 2007
Last Updated: August 29, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Alabama at Birmingham:
Chronic Obstructive Pulmonary Disease
COPD
Exacerbation
Macrolide

Additional relevant MeSH terms:
Chronic Disease
Inflammation
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014