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

NCT00431964 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2015-08-19

Study results available
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Summary

This is a study to examine the safety, effect on lung function, and frequency of symptoms relating to cystic fibrosis during 24 weeks of treatment with the antibiotic azithromycin in 6-18 year-olds with CF who are not infected with Pseudomonas aeruginosa.

Conditions

Interventions

DRUG

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

DRUG

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

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • CF Therapeutics Development Network Coordinating Center

    lead NETWORK

Principal Investigators

  • Lisa Saiman, MD, MPH · Columbia University

  • Michael Anstead, MD · University of Kentucky

  • Felix Ratjen, MD · The Hospital for Sick Children, Toronto, Ontario

  • Larry Lands, MD · Montreal Children's Hospital of the MUHC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2009-07-31
Completion
2009-11-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00431964 on ClinicalTrials.gov