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Macrolide Azithromycin to Prevent Rapid Worsening of Symptoms Associated With Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT00325897
Recruitment Status : Completed
First Posted : May 15, 2006
Results First Posted : June 7, 2012
Last Update Posted : November 18, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Minnesota

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Pulmonary Disease, Chronic Obstructive
Interventions Drug: Macrolide Antibiotic (Azithromycin)
Drug: Placebo
Enrollment 1142
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Azithromycin Placebo
Hide Arm/Group Description Azithromycin, 250 mg Inactive sugar pill
Period Title: Overall Study
Started 570 572
Completed 558 559
Not Completed 12 13
Reason Not Completed
Lost to Follow-up             12             13
Arm/Group Title Azithromycin Placebo Total
Hide Arm/Group Description Azithromycin, 250 mg Inactive sugar pill Total of all reporting groups
Overall Number of Baseline Participants 570 572 1142
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 570 participants 572 participants 1142 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
277
  48.6%
261
  45.6%
538
  47.1%
>=65 years
293
  51.4%
311
  54.4%
604
  52.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 570 participants 572 participants 1142 participants
64.8  (8.7) 65.5  (8.4) 65.1  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 570 participants 572 participants 1142 participants
Female
234
  41.1%
229
  40.0%
463
  40.5%
Male
336
  58.9%
343
  60.0%
679
  59.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 570 participants 572 participants 1142 participants
Hispanic or Latino
11
   1.9%
14
   2.4%
25
   2.2%
Not Hispanic or Latino
559
  98.1%
558
  97.6%
1117
  97.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 570 participants 572 participants 1142 participants
American Indian or Alaska Native
2
   0.4%
2
   0.3%
4
   0.4%
Asian
6
   1.1%
4
   0.7%
10
   0.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   0.3%
2
   0.2%
Black or African American
79
  13.9%
89
  15.6%
168
  14.7%
White
463
  81.2%
457
  79.9%
920
  80.6%
More than one race
20
   3.5%
18
   3.1%
38
   3.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: All applicable categories were checked for each participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 570 participants 572 participants 1142 participants
570 572 1142
1.Primary Outcome
Title Time Until First Occurrence of Acute Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Hide Description Time until first occurrence of acute Chronic Obstructive Pulmonary Disease (COPD) exacerbation. Acute exacerbations are defined as a "complex of respiratory symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of at least three days requiring treatment with antibiotics and/or systemic steroids "
Time Frame Measured monthly through 13 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that had any follow-up data were included in analysis.
Arm/Group Title Azithromycin Placebo
Hide Arm/Group Description:
Azithromycin 250 mg
Inactive sugar pill
Overall Number of Participants Analyzed 558 559
Median (95% Confidence Interval)
Unit of Measure: Days
266
(227 to 313)
174
(143 to 215)
2.Secondary Outcome
Title Exacerbations/Patient Year
Hide Description Acute exacerbations are defined as a "complex of respiratory symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of at least three days requiring treatment with antibiotics and/or systemic steroids "
Time Frame Measured monthly until 13 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with any follow-up data were analyzed.
Arm/Group Title Azithromycin Placebo
Hide Arm/Group Description:
Azithromycin, 250 mg
Inactive sugar pill
Overall Number of Participants Analyzed 558 559
Measure Type: Number
Unit of Measure: exacerbations/patient year
1.48 1.83
3.Secondary Outcome
Title Number of Emergency Department Visits as a Result of Acute Exacerbations
Hide Description [Not Specified]
Time Frame Measured monthly for 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Azithromycin Placebo
Hide Arm/Group Description:
Azithromycin, 250 mg
Inactive sugar pill
Overall Number of Participants Analyzed 570 572
Measure Type: Number
Unit of Measure: Visits
199 257
4.Secondary Outcome
Title Number of Hospital Admissions as a Result of Acute Exacerbations
Hide Description [Not Specified]
Time Frame Measured monthly for 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Azithromycin Placebo
Hide Arm/Group Description:
Azithromycin 250 mg
Inactive sugar pill
Overall Number of Participants Analyzed 570 572
Measure Type: Number
Unit of Measure: Hospitalizations
156 200
5.Secondary Outcome
Title Change in Age-adjusted Hearing Threshold
Hide Description Assessed by audiometry for four sound frequencies (1000, 2000, 3000, 4000 Hz). The maximum was computed for each threshold in each ear for all frequencies, then the differences between visits were assessed.
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with both baseline and one-year audiometry data available were analyzed.
Arm/Group Title Azithromycin, 250 mg Placebo
Hide Arm/Group Description:

Macrolide Antibiotic (Azithromycin)

Macrolide Antibiotic (Azithromycin): Azithromycin (daily capsule, 250 mg for 12 months)

Inactive

Placebo: Placebo taken on a daily basis

Overall Number of Participants Analyzed 420 426
Mean (Standard Deviation)
Unit of Measure: Decibels (db)
-1.2  (4.2) -0.9  (4.1)
6.Secondary Outcome
Title Incidence of Macrolide-resistant Bacterial Colonization of the Nasopharynx or Sputum
Hide Description Cultures from 68% of the participants in the azithromycin group and 70% in the placebo group who were not colonized with selected respiratory pathogens at the time of enrollment but who became colonized during the course of the study were available for susceptibility testing for the incidence of macrolide-resistant bacterial colonization.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Using cultures from participants who were not colonized with selected respiratory pathogens at the time of enrollment but who became colonized during the course of the study, samples were available from 68% of the participants in the azithromycin group and 70% in the placebo group among these cultures.
Arm/Group Title Azithromycin, 250 mg Placebo
Hide Arm/Group Description:

Macrolide Antibiotic (Azithromycin)

Macrolide Antibiotic (Azithromycin): Azithromycin (daily capsule, 250 mg for 12 months)

Inactive

Placebo: Placebo taken on a daily basis

Overall Number of Participants Analyzed 44 49
Measure Type: Number
Unit of Measure: Participants
23 28
7.Secondary Outcome
Title Incidence of Macrolide-resistant Bacterial Colonization of the Nasopharynx or Sputum
Hide Description Cultures from some participants who were not colonized with selected respiratory pathogens at the time of enrollment but who became colonized during the course of the study were available for susceptibility testing for the incidence of macrolide-resistant bacterial colonization.
Time Frame During Course of Study (either month 3, 6, 9, or 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Using cultures from participants who were not colonized with selected respiratory pathogens at the time of enrollment but who became colonized during the course of the study, samples were available from 68% of the participants in the azithromycin group and 70% in the placebo group among these cultures.
Arm/Group Title Azithromycin, 250 mg Placebo
Hide Arm/Group Description:

Macrolide Antibiotic (Azithromycin)

Macrolide Antibiotic (Azithromycin): Azithromycin (daily capsule, 250 mg for 12 months)

Inactive

Placebo: Placebo taken on a daily basis

Overall Number of Participants Analyzed 47 108
Measure Type: Number
Unit of Measure: participants
38 44
Time Frame 13 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Azithromycin Placebo
Hide Arm/Group Description Azithromycin, 250 mg Inactive sugar pill
All-Cause Mortality
Azithromycin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Azithromycin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   217/570 (38.07%)      217/572 (37.94%)    
Cardiac disorders     
Circulatory  1  32/570 (5.61%)  32 31/572 (5.42%)  36
Gastrointestinal disorders     
Digestive  1  15/570 (2.63%)  15 18/572 (3.15%)  21
General disorders     
Other  1  100/570 (17.54%)  113 101/572 (17.66%)  114
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm  1  6/570 (1.05%)  7 8/572 (1.40%)  13
Respiratory, thoracic and mediastinal disorders     
Pneumonia  1  24/570 (4.21%)  26 37/572 (6.47%)  41
COPD Exacerbation  1  120/570 (21.05%)  145 109/572 (19.06%)  170
Indicates events were collected by systematic assessment
1
Term from vocabulary, ICD-9
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Azithromycin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   500/570 (87.72%)      444/572 (77.62%)    
Cardiac disorders     
Circulatory  1  34/570 (5.96%)  49 29/572 (5.07%)  42
Gastrointestinal disorders     
Digestive  1  62/570 (10.88%)  89 78/572 (13.64%)  104
General disorders     
Other  1  319/570 (55.96%)  1132 331/572 (57.87%)  1176
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm  1  13/570 (2.28%)  13 15/572 (2.62%)  16
Respiratory, thoracic and mediastinal disorders     
Pneumonia  1  7/570 (1.23%)  13 24/572 (4.20%)  27
COPD Exacerbation  1  185/570 (32.46%)  566 244/572 (42.66%)  657
Indicates events were collected by systematic assessment
1
Term from vocabulary, ICD-9
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Richard Albert
Organization: Denver Health Medical Center
Phone: 303-436-6900
EMail: ralbert@dhha.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT00325897    
Other Study ID Numbers: 0510M76766
U10HL074424-03 ( U.S. NIH Grant/Contract )
First Submitted: May 12, 2006
First Posted: May 15, 2006
Results First Submitted: August 18, 2011
Results First Posted: June 7, 2012
Last Update Posted: November 18, 2019