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

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00325897
First received: May 12, 2006
Last updated: August 25, 2016
Last verified: August 2016
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 
Overall Participants Analyzed 
[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 
[1] All applicable categories were checked for each participant.
Region of Enrollment 
[Units: Participants]
     
United States   570   572   1142 


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

2.  Secondary:   Exacerbations/Patient Year   [ Time Frame: Measured monthly until 13 months ]

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

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

5.  Secondary:   Change in Age-adjusted Hearing Threshold   [ Time Frame: Baseline and 12 months ]

6.  Secondary:   Incidence of Macrolide-resistant Bacterial Colonization of the Nasopharynx or Sputum   [ Time Frame: Baseline ]

7.  Secondary:   Incidence of Macrolide-resistant Bacterial Colonization of the Nasopharynx or Sputum   [ Time Frame: During Course of Study (either month 3, 6, 9, or 12) ]


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00325897     History of Changes
Other Study ID Numbers: 397
U10HL074424-03 ( US NIH Grant/Contract Award Number )
Study First Received: May 12, 2006
Results First Received: August 18, 2011
Last Updated: August 25, 2016
Health Authority: United States: Federal Government