Effect of Macrolide Antibiotics on Airway Inflammation in People With Chronic Obstructive Pulmonary Disease (COPD)
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|ClinicalTrials.gov Identifier: NCT00549445|
Recruitment Status : Completed
First Posted : October 25, 2007
Results First Posted : August 14, 2017
Last Update Posted : September 29, 2017
|Condition or disease||Intervention/treatment|
|Pulmonary Disease, Chronic Obstructive||Drug: Azithromycin Drug: Placebo|
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 Type :||Observational|
|Actual Enrollment :||53 participants|
|Official Title:||Effect of Macrolide Treatment on a Novel Pathway of Neutrophilic Inflammation in COPD|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2012|
Participants in the COPD Network Macrolide Study who received azithromycin for 1 year.
250 mg daily
Participants in the COPD Network Macrolide Study who received placebo for 1 year.
- 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
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
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||James E. Blalock, PhD||University of Alabama at Birmingham|