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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:
ClinicalTrials.gov Identifier:
NCT00431964
First Posted: February 6, 2007
Last Update Posted: August 19, 2015
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:
Cystic Fibrosis Foundation Therapeutics
Information provided by (Responsible Party):
CF Therapeutics Development Network Coordinating Center
Results First Submitted: July 24, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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Parental Consent Withdrawn                0                2 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 
Overall Participants Analyzed 
[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 by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: CF Therapeutics Development Network Coordinating Center
ClinicalTrials.gov Identifier: NCT00431964     History of Changes
Other Study ID Numbers: AZ0004
First Submitted: February 2, 2007
First Posted: February 6, 2007
Results First Submitted: July 24, 2015
Results First Posted: August 19, 2015
Last Update Posted: August 19, 2015