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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00431964
• Date of registration: 02/02/2007
• Prospective Registration: No
• Primary sponsor: CF Therapeutics Development Network Coordinating Center
• Public title: Effect of Azithromycin on Lung Function in 6-18 Year-olds With Cystic Fibrosis (CF) Not Infected With P. Aeruginosa
• Scientific title: Multi-center, Multi-national, Randomized, Placebo-Controlled Trial of Azithromycin in Subjects With Cystic Fibrosis 6-18 Years Old, Culture Negative for Pseudomonas Aeruginosa
• Date of first enrolment: February 2007
• Target sample size: 263
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00431964
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

Canada, United States

Contacts

• Name: Lisa Saiman, MD, MPH
• Affiliation: Columbia University

• Name: Felix Ratjen, MD
• Affiliation: The Hospital for Sick Children, Toronto, Ontario

• Name: Michael Anstead, MD
• Affiliation: University of Kentucky

• Name: Larry Lands, MD
• Affiliation: Montreal Children's Hospital of the MUHC

Key inclusion & exclusion 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



Age minimum: 6 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: placebo tablets

Drug: azithromycin 250 mg tablets

Primary Outcome(s)

Change in FEV1 From Baseline to End of Treatment at Day 168 [Time Frame: change from baseline to day 168]

Secondary ID(s)

AZ0004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cystic Fibrosis Foundation Therapeutics

Results

• Results available: Yes
• Date Posted: 19/08/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00431964