Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis
This trial is active, not recruiting.
|Treatment||biaxin ( clarithromycin)|
|Sponsor||Wake Forest School of Medicine|
|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.
|Endpoint classification||efficacy study|
|Intervention model||crossover assignment|
Pulmonary Function Testing - FEV1
Quality of Life
decrease in neutrophil-dominated airway inflammation
decrease in Pseudomonas alginate production in vitro and in the airway
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
|Official title||Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis|
|Principal investigator||Bruce K Rubin, MEngr,MD,MBA|
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