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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00549445
First Posted: October 25, 2007
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
J Edwin Blalock, University of Alabama at Birmingham
Results First Submitted: April 13, 2017  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: Azithromycin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Azithromycin-treated   Placebo-treated
STARTED   23   30 
COMPLETED   8   13 
NOT COMPLETED   15   17 
Sputum & Blood Samples Not Available                15                17 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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. Therefore, this greatly reduced the overall number of participants analyzed.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   Azithromycin-treated   Placebo-treated   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   30   53 
Age 
[Units: Years]
Mean (Full Range)
 64.4 
 (56 to 72.8) 
 70.8 
 (62.4 to 79.2) 
 67.6 
 (56 to 79.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   6   10   16 
Male   17   20   37 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   11   12   23 
White   12   18   30 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   23   30   53 


  Outcome Measures

1.  Primary:   Levels of PGP From Sputum Samples of COPD Patients Being Treated With Azithromycin.   [ Time Frame: Baseline to 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: J. Edwin Blalock, PhD
Organization: University of Alabama at Birmingham
phone: 205-934-6439
e-mail: blalock@uab.edu



Responsible Party: J Edwin Blalock, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00549445     History of Changes
Other Study ID Numbers: 1425
R01HL090999-01 ( U.S. NIH Grant/Contract )
HL090999-01
First Submitted: October 24, 2007
First Posted: October 25, 2007
Results First Submitted: April 13, 2017
Results First Posted: August 14, 2017
Last Update Posted: September 29, 2017