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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00325897
First received: May 12, 2006
Last updated: June 18, 2013
Last verified: June 2013
Results First Received: August 18, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: Macrolide Antibiotic (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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Azithromycin Azithromycin, 250 mg
Placebo Inactive sugar pill

Participant Flow:   Overall Study
    Azithromycin     Placebo  
STARTED     570     572  
COMPLETED     558     559  
NOT COMPLETED     12     13  
Lost to Follow-up                 12                 13  



  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.
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Reporting Groups
  Description
Azithromycin Azithromycin, 250 mg
Placebo Inactive sugar pill
Total Total of all reporting groups

Baseline Measures
    Azithromycin     Placebo     Total  
Number of Participants  
[units: participants]
  570     572     1142  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     277     261     538  
>=65 years     293     311     604  
Age  
[units: years]
Mean ± Standard Deviation
  64.8  ± 8.7     65.5  ± 8.4     65.1  ± 8.6  
Gender  
[units: participants]
     
Female     234     229     463  
Male     336     343     679  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     11     14     25  
Not Hispanic or Latino     559     558     1117  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB) [1]
[units: participants]
     
American Indian or Alaska Native     2     2     4  
Asian     6     4     10  
Native Hawaiian or Other Pacific Islander     0     2     2  
Black or African American     79     89     168  
White     463     457     920  
More than one race     20     18     38  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     570     572     1142  
[1] All applicable categories were checked for each participant.



  Outcome Measures
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1.  Primary:   Time Until First Occurrence of Acute COPD (Chronic Obstructive Pulmonary Disease) Exacerbation   [ Time Frame: Measured monthly through 13 months ]

2.  Secondary:   Exacerbations/Patient-year   [ Time Frame: Measured montly until 13 months ]

3.  Secondary:   Number of Emergency Department Visits as a Result of Acute Exacerbations   [ Time Frame: Measured at 12-13 months ]

4.  Secondary:   Number of Hospital Admissions as a Result of Acute Exacerbations   [ Time Frame: Measured at 12-13 months ]

5.  Secondary:   Incidence of Presumed Macrolide-related Side-effects   [ Time Frame: Measured at 12-13 months ]
Results not yet posted.   Anticipated Posting Date:   01/2013   Safety Issue:   Yes

6.  Secondary:   Incidence of Presumed Macrolide-related Side Effects That Require Cessation of Treatment   [ Time Frame: Measured at 12 months ]
Results not yet posted.   Anticipated Posting Date:   01/2013   Safety Issue:   Yes

7.  Secondary:   Incidence of Macrolide-resistant Bacterial Colonization of the Nasopharynx or Sputum   [ Time Frame: Measured at 12-13 months ]
Results not yet posted.   Anticipated Posting Date:   01/2013   Safety Issue:   Yes

8.  Secondary:   Incidence of Pneumonia or Acute Bronchitis   [ Time Frame: Measured at 12-13 months ]
Results not yet posted.   Anticipated Posting Date:   01/2013   Safety Issue:   No

9.  Secondary:   Quality of Life   [ Time Frame: Measured at 12-13 months ]
Results not yet posted.   Anticipated Posting Date:   01/2013   Safety Issue:   No


  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
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  More Information
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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:  
Name/Title: Dr. Richard Albert
Organization: Denver Health Medical Center
phone: 303-436-6900
e-mail: ralbert@dhha.org


No publications provided by University of Minnesota - Clinical and Translational Science Institute

Publications automatically indexed to this study:

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00325897     History of Changes
Other Study ID Numbers: 397, U10HL074424-03
Study First Received: May 12, 2006
Results First Received: August 18, 2011
Last Updated: June 18, 2013
Health Authority: United States: Federal Government