This trial is active, not recruiting.

Condition cystic fibrosis
Treatment biaxin ( clarithromycin)
Sponsor Wake Forest School of Medicine
Collaborator Abbott
Start date December 2000
End date October 2004
Trial size 50 participants
Trial identifier NCT00205634, BG99-486


The purpose of this study is to evaluate whether Biaxin (clarithromycin) improves sputum abnormalities, lung function, and overall feeling of well-being in people with cystic fibrosis (CF). Biaxin is an antibiotic commonly used for the treatment of respiratory infections in people who do not have CF, and is sometimes used in CF patients as well. Studies done in a disease called diffuse panbronchiolitis (which is similar to CF) and some preliminary studies that have been done in CF patients suggest that Biaxin might have a beneficial effect on CF sputum in ways unrelated to its antibiotic activity.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Pulmonary Function Testing - FEV1
time frame:
Quality of Life
time frame:

Secondary Outcomes

decrease in neutrophil-dominated airway inflammation
time frame:
decrease in Pseudomonas alginate production in vitro and in the airway
time frame:

Eligibility Criteria

Male or female participants from 6 years up to 50 years old.

Inclusion Criteria: - diagnosis of CF - ability to reliably perform spirometry - FEV1 of 30% predicted at the time of screening Exclusion Criteria: - Mycobacterium in a sputum culture ever recorded - a respiratory exacerbation requiring IV antibiotics in the 60 days prior - used a investigational drug or device in the 60 days prior - significant (>30ml) of hemoptysis in the past year - require oxygen or have significant liver or renal disease

Additional Information

Official title Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis
Principal investigator Bruce K Rubin, MEngr,MD,MBA
Trial information was received from ClinicalTrials.gov and was last updated in December 2007.
Information provided to ClinicalTrials.gov by Wake Forest School of Medicine.