Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis

Condition(s) targeted: Cystic Fibrosis

Intervention: Biaxin ( clarithromycin) (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Wake Forest University

Official(s) and/or principal investigator(s):
Bruce K Rubin, MEngr,MD,MBA, Principal Investigator, Affiliation: Wake Forest University

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.

Official title: Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Primary outcome:

Pulmonary Function Testing - FEV1

Quality of Life

Secondary outcome:

decrease in neutrophil-dominated airway inflammation

decrease in Pseudomonas alginate production in vitro and in the airway

Minimum age: 6 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

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

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States

Starting date: December 2000
Ending date: October 2004
Last updated: December 13, 2007