Effect of Macrolide Antibiotics on Airway Inflammation in People With Chronic Obstructive Pulmonary Disease (COPD)

NCT00549445 | Completed Results FDA Drug

• 3 other identifiers: 1425R01HL090999-01HL090999-01
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary Disease; COPD; Exacerbation; Macrolide

Outcome Measures

Primary Outcomes (1)

• Levels of PGP From Sputum Samples of COPD Patients Being Treated With Azithromycin.

  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).

  Baseline to 12 months

Study Arms (2)

Azithromycin-treated

Participants in the COPD Network Macrolide Study who received azithromycin for 1 year.

Drug: Azithromycin

Placebo-treated

Participants in the COPD Network Macrolide Study who received placebo for 1 year.

Drug: Placebo

Interventions

Azithromycin DRUG

250 mg daily

Azithromycin-treated

Placebo DRUG

Daily

Placebo-treated

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community

You may qualify if:

• Participating in the COPD Network Macrolide study
• Clinical diagnosis of at least moderate COPD
• Cigarette consumption of 10 pack years or more

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and Plasma

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Limitations and Caveats

We were limited by the number of participants included in this study is small, as sputum samples were available only from a minority of participants in the parent trial.

Results Point of Contact

• Title: J. Edwin Blalock, PhD
• Organization: University of Alabama at Birmingham

blalock@uab.edu

205-934-6439

Study Officials

• James E. Blalock, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medicine-Pulm/Allergy/Clinical

Study Record Dates

• First Submitted: October 24, 2007
• First Posted: October 25, 2007
• Study Start: August 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2012
• Last Updated: September 29, 2017
• Results First Posted: August 14, 2017

Record last verified: 2017-08

Locations

US (1)