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

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CF Therapeutics Development Network Coordinating Center
• Collaborators: Cystic Fibrosis Foundation; Cystic Fibrosis Foundation Therapeutics
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

• Male or female, 6-18 years of age at enrollment

• Confirmed diagnosis of CF

• Written informed consent (and assent when applicable)

• Clinically stable at enrollment as assessed by the site investigator

• FEV1 % predicted > 50%

• Ability to comply with medication use, study visits, and study procedures

• Ability to swallow a 250 mg tablet

Exclusion Criteria:

• Weight less than 18.0 kg

• Respiratory culture positive for P. aeruginosa, NTM, or B. cepacia complex within 1 year or at screening, or AFB positive at screening

• Allergy to macrolide antibiotics

• Use of macrolide antibiotics (e.g., azithromycin, clarithromycin) within 60 days of screening

• Use of systemic corticosteroids or intravenous or oral antibiotics within 14 days of screening

• Initiation of high dose ibuprofen, Pulmozyme®, hypertonic saline or aerosolized antibiotics within 30 days of screening

• Chronic therapy with drugs known to have rare but serious interactions with azithromycin: amiodarone, digoxin, disopyramide, lovastatin, pimozide, rifabutin, and nelfinavir

• Investigational drug use within 30 days of screening

• Laboratory abnormalities (creatinine, liver function or neutropenia) at screening and confirmed at follow-up testing prior to randomization

• History of biliary cirrhosis, portal hypertension, or splenomegaly, or splenomegaly on physical exam

• History of ventricular arrhythmia

• Other major organ dysfunction, excluding pancreatic dysfunction

• History of lung transplantation or currently on lung transplant list

• Relative decrease in FEV1 % predicted ≥ 20% between the screening and enrollment visit

• Positive serum pregnancy test at screening

• Pregnant, breastfeeding, or if post-menarche female, unwilling to practice birth control during participation in the study

• History of alcohol, illicit drug or medication abuse within 1 year of screening in the judgment of the site investigator

• Presence of a condition or abnormality that in the opinion of the site investigator would compromise the safety of the subject or the quality of the data