Effect of Azithromycin on Lung Function in 6-18 Year-olds With Cystic Fibrosis (CF) Not Infected With P. Aeruginosa
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: azithromycin 250 mg tablets; placebo tablets
Intervention description: 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; 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
Intervention MeSH terms: Azithromycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 263.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: azithromycin, Zithromax

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.
    

Eligibility 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