Effect of Macrolide Treatment on a Novel Pathway of Neutrophilic Inflammation in COPD
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| City: |
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Birmingham |
| State: |
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Alabama |
| Zip Code: |
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35294 |
| Conditions: |
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Pulmonary Disease, Chronic Obstructive |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00549445 |
| Primary Contact: |
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Principal Investigator
James E. Blalock, PhD
University of Alabama at Birmingham
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| Backup Contact: |
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N/A |
| Location Contact: |
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Birmingham, Alabama 35294
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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