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

Completed · Phase 4 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT00431964

Run by

CF Therapeutics Development Network Coordinating Center

People needed

263

Starts

2007-02-01

Expected to finish

2009-11-01

Last updated by the study team

2015-08-19

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Emory University — Atlanta, Georgia, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• University of Kentucky — Lexington, Kentucky, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Washington University — St Louis, Missouri, United States
• University of Nebraska Medical Center - Pediatric Pulmonary — Omaha, Nebraska, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Columbia University — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• New York Medical College — Valhalla, New York, United States
• UNC Chapel Hill — Chapel Hill, North Carolina, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• St. Christopher's Hospital for Children — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh, Pulmonary Medicine, Allergy & Immunology — Pittsburgh, Pennsylvania, United States
• East Tennessee Children's Hospital, Pediatric Pulmonary & Respiratory Care — Knoxville, Tennessee, United States
• University of Tennessee Health Science Center — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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