Status:
COMPLETED
Effect of Azithromycin on Lung Function in 6-18 Year-olds With Cystic Fibrosis (CF) Not Infected With P. Aeruginosa
Lead Sponsor:
CF Therapeutics Development Network Coordinating Center
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
Brief 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 wi...
Detailed Description
Azithromycin is an antibiotic that has been shown to improve lung function in patients with cystic fibrosis (CF) whose lungs are infected with a bacterium called Pseudomonas aeruginosa. Scientists are...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
263 Patients enrolled
Trial Details
Trial ID
NCT00431964
Start Date
February 1 2007
End Date
November 1 2009
Last Update
August 19 2015
Active Locations (40)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
3
Emory University
Atlanta, Georgia, United States, 30322
4
Children's Memorial Hospital
Chicago, Illinois, United States, 60614