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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00549445
First Posted: October 25, 2007
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
J Edwin Blalock, University of Alabama at Birmingham
  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 J Edwin Blalock, University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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).



Biospecimen Retention:   Samples Without DNA
Serum and Plasma

Enrollment: 53
Study Start Date: August 2007
Study Completion Date: July 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00549445


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: James E. Blalock, PhD University of Alabama at Birmingham
  More Information

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 ( U.S. NIH Grant/Contract )
HL090999-01
First Submitted: October 24, 2007
First Posted: October 25, 2007
Results First Submitted: April 13, 2017
Results First Posted: August 14, 2017
Last Update Posted: September 29, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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

Additional relevant MeSH terms:
Lung Diseases
Inflammation
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Pathologic Processes
Disease Attributes