Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis

Completed · Phase 2

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT00205634

Run by

Wake Forest University

People needed

50

Starts

2000-12-01

Expected to finish

2004-10-01

Last updated by the study team

2018-08-13

Who can join

Age: 6 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• diagnosis of CF
• ability to reliably perform spirometry
• FEV1 of 30% predicted at the time of screening

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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