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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
October 24, 2007
October 25, 2007
April 13, 2017
August 14, 2017
September 29, 2017
August 2007
July 2011   (Final data collection date for primary outcome measure)
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).

Time to first COPD exacerbation [ Time Frame: Measured at Year 1 ]
Complete list of historical versions of study NCT00549445 on ClinicalTrials.gov Archive Site
Not Provided
Alteration in levels of PGP and matrix metalloprotease (MMP) in blood and sputum [ Time Frame: Measured at Year 1 ]
Not Provided
Not Provided
 
Effect of Macrolide Antibiotics on Airway Inflammation in People With Chronic Obstructive Pulmonary Disease (COPD)
Effect of Macrolide Treatment on a Novel Pathway of Neutrophilic Inflammation in COPD
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples Without DNA
Description:
Serum and Plasma
Non-Probability Sample
Community
Pulmonary Disease, Chronic Obstructive
  • Drug: Azithromycin
    250 mg daily
  • Drug: Placebo
    Daily
  • Azithromycin-treated
    Participants in the COPD Network Macrolide Study who received azithromycin for 1 year.
    Intervention: Drug: Azithromycin
  • Placebo-treated
    Participants in the COPD Network Macrolide Study who received placebo for 1 year.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
July 2012
July 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00549445
1425
R01HL090999-01 ( U.S. NIH Grant/Contract )
HL090999-01
No
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
Not Provided
J Edwin Blalock, University of Alabama at Birmingham
University of Alabama at Birmingham
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: James E. Blalock, PhD University of Alabama at Birmingham
University of Alabama at Birmingham
August 2017