Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis
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ClinicalTrials.gov Identifier: NCT00205634
Recruitment Status :
First Posted : September 20, 2005
Last Update Posted : August 10, 2017
Wake Forest University
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( 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.
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Ages Eligible for Study:
6 Years to 50 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
diagnosis of CF
ability to reliably perform spirometry
FEV1 of 30% predicted at the time of screening
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