CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 263 enrolled
Drug / intervention
azithromycin 250 mg tablets +1 moredrug
Likely dose
azithromycin 250 mg tabletsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00431964
NCT00431964Phase 4Completed

Multi-center, Multi-national, Randomized, Placebo-Controlled Trial of Azithromycin in Subjects With Cystic Fibrosis 6-18 Years Old, Culture Negative for Pseudomonas Aeruginosa

CF Therapeutics Development Network Coordinating Center·interventional·Posted Feb 6, 2007·Updated Aug 19, 2015

In Brief

A Phase 4 clinical trial evaluating azithromycin 250 mg tablets and placebo tablets for Cystic Fibrosis. Completed, enrolled 263 participants across 40 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesCanada, United States

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 6, 2007
Enrollment StartFeb 1, 2007
Primary CompletionJul 1, 2009
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 19.4 years ago

Interventions

azithromycin 250 mg tabletsdrug

* 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 tabletsdrug

* 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