Effect of Macrolide Antibiotics on Airway Inflammation in People With Chronic Obstructive Pulmonary Disease (COPD)
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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 |
- Time to first COPD exacerbation [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
- 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 |
Community
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| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| 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 May 23, 2013