Effect of Macrolide Antibiotics on Airway Inflammation in People With Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Abstract
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.
Dates
| Last Verified: | 07/31/2017 |
| First Submitted: | 10/23/2007 |
| Estimated Enrollment Submitted: | 10/23/2007 |
| First Posted: | 10/24/2007 |
| Last Update Submitted: | 08/30/2017 |
| Last Update Posted: | 09/28/2017 |
| Date of first submitted results: | 04/12/2017 |
| Date of first submitted QC results: | 07/06/2017 |
| Date of first posted results: | 08/13/2017 |
| Actual Study Start Date: | 07/31/2007 |
| Estimated Primary Completion Date: | 06/30/2011 |
| Estimated Study Completion Date: | 06/30/2012 |
Condition or disease
Intervention/treatment
Drug: Azithromycin-treated
Drug: Placebo-treated
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Azithromycin-treated Participants in the COPD Network Macrolide Study who received azithromycin for 1 year. | Drug: Azithromycin-treated 250 mg daily |
| Placebo-treated Participants in the COPD Network Macrolide Study who received placebo for 1 year. | Drug: Placebo-treated Daily |
Eligibility Criteria
| Ages Eligible for Study | 40 Years To 40 Years |
| Sexes Eligible for Study | All |
| Sampling method | Non-Probability Sample |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Levels of PGP From Sputum Samples of COPD Patients Being Treated With Azithromycin. [Baseline to 12 months]
