Overview

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