Effect of Azithromycin on Lung Function in 6-18 Year-olds With Cystic Fibrosis (CF) Not Infected With P. Aeruginosa

This study has been completed.
Sponsor:
Collaborator:
Cystic Fibrosis Foundation Therapeutics
Information provided by (Responsible Party):
CF Therapeutics Development Network Coordinating Center
ClinicalTrials.gov Identifier:
NCT00431964
First received: February 2, 2007
Last updated: July 24, 2015
Last verified: July 2015
Results First Received: July 24, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cystic Fibrosis
Interventions: Drug: azithromycin 250 mg tablets
Drug: placebo tablets

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Active

azithromycin 250 mg tablets

azithromycin 250 mg tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs

*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs

Placebo

placebo tablets (matched to active drug in appearance)

placebo tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs

*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs


Participant Flow:   Overall Study
    Active     Placebo  
STARTED     131     132  
Randomized/Received Drug     131     129  
Did Not Receive Drug     0     3  
Withdrew From Study     6     5  
COMPLETED     125     124  
NOT COMPLETED     6     8  
Adverse Event                 1                 0  
Lost to Follow-up                 1                 2  
Physician Decision                 2                 2  
Withdrawal by Subject                 2                 1  
Parental Consent Withdrawn                 0                 2  
Due to Unstable Health                 0                 1  



  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.
3 participants in the Placebo arm were randomized but did not receive drug due to withdrawal of consent and unstable health.

Reporting Groups
  Description
Active

azithromycin 250 mg tablets

azithromycin 250 mg tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs

*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs

Placebo

placebo tablets (matched to active drug in appearance)

placebo tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs

*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs

Total Total of all reporting groups

Baseline Measures
    Active     Placebo     Total  
Number of Participants  
[units: participants]
  131     129     260  
Age  
[units: participants]
     
<=18 years     131     129     260  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  10.7  (3.25)     10.6  (3.10)     10.7  (3.17)  
Gender  
[units: participants]
     
Female     54     59     113  
Male     77     70     147  



  Outcome Measures

1.  Primary:   Change in FEV1 From Baseline to End of Treatment at Day 168   [ Time Frame: change from baseline to day 168 ]


  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: Nicole Hamblett
Organization: Seattle Children's Hospital
phone: 206-987-5725
e-mail: tdncc@seattlechildrens.org


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: CF Therapeutics Development Network Coordinating Center
ClinicalTrials.gov Identifier: NCT00431964     History of Changes
Other Study ID Numbers: AZ0004
Study First Received: February 2, 2007
Results First Received: July 24, 2015
Last Updated: July 24, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Health Canada