Trial Outcomes & Findings for Effect of Macrolide Antibiotics on Airway Inflammation in People With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT00549445)

Last Updated: 2017-09-29

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

53 participants

Primary outcome timeframe

Baseline to 12 months

Results posted on

2017-09-29

Participant Flow

Protocol Open to Accrual: August 2007, Primary Completion Date: July 2011 and Study Completion Date: July 2012. Recruitment location: University of Alabama at Birmingham and the Mayo Clinic.

This research was conducted as an ancillary study to a multicenter trial (NCT00325897) of the efficacy of azithromycin treatment for 1 year in preventing chronic obstructive pulmonary disease (COPD) exacerbations to test whether sputum levels of proline-glycine-proline (PGP) were altered by treatment or associated with exacerbation frequency.

Participant milestones

Participant milestones
Measure	Azithromycin-treated Participants in the COPD Network Macrolide Study who received azithromycin for 1 year. Azithromycin: 250 mg daily	Placebo-treated Participants in the COPD Network Macrolide Study who received placebo for 1 year. Placebo: Daily
Overall Study STARTED	23	30
Overall Study COMPLETED	8	13
Overall Study NOT COMPLETED	15	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Azithromycin-treated Participants in the COPD Network Macrolide Study who received azithromycin for 1 year. Azithromycin: 250 mg daily	Placebo-treated Participants in the COPD Network Macrolide Study who received placebo for 1 year. Placebo: Daily
Overall Study Sputum & Blood Samples Not Available	15	17

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Azithromycin-treated n=23 Participants Participants in the COPD Network Macrolide Study who received azithromycin for 1 year. Azithromycin: 250 mg daily	Placebo-treated n=30 Participants Participants in the COPD Network Macrolide Study who received placebo for 1 year. Placebo: Daily	Total n=53 Participants Total of all reporting groups
Age, Continuous	64.4 years n=5 Participants	70.8 years n=7 Participants	67.6 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	20 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	18 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	23 Participants n=5 Participants	30 Participants n=7 Participants	53 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 12 months

Population: Levels of PGP from sputum samples are compared between subjects on the macrolide antibiotic, azithromycin, and subjects on placebo and correlated with neutrophil counts and protease activity in sputum.

Outcome measures

Outcome measures
Measure	Azithromycin-treated n=8 Participants Participants in the COPD Network Macrolide Study who received azithromycin for 1 year. Azithromycin: 250 mg daily	Placebo-treated n=13 Participants Participants in the COPD Network Macrolide Study who received placebo for 1 year. Placebo: Daily
Levels of PGP From Sputum Samples of COPD Patients Being Treated With Azithromycin.	2.27 ng/mL Interval 1.4 to 3.14	5.15 ng/mL Interval 3.61 to 6.69

Adverse Events

Azithromycin-treated

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo-treated

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

J. Edwin Blalock, PhD

University of Alabama at Birmingham

Phone: 205-934-6439

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place