Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis

Phase 2CompletedNCT00205634

Wake Forest University50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cystic Fibrosis

Interventions

Biaxin ( clarithromycin)DRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Pulmonary Function Testing - FEV1

Quality of Life

Secondary Outcomes

decrease in neutrophil-dominated airway inflammation

decrease in Pseudomonas alginate production in vitro and in the airway

Data from ClinicalTrials.gov

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