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Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2007 by Wake Forest University Health Sciences.
Recruitment status was:  Active, not recruiting
Information provided by:
Wake Forest University Health Sciences Identifier:
First received: September 12, 2005
Last updated: December 13, 2007
Last verified: December 2007

September 12, 2005
December 13, 2007
December 2000
Not Provided
  • Pulmonary Function Testing - FEV1
  • Quality of Life
Same as current
Complete list of historical versions of study NCT00205634 on Archive Site
  • decrease in neutrophil-dominated airway inflammation
  • decrease in Pseudomonas alginate production in vitro and in the airway
Same as current
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Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis
Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis
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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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Cystic Fibrosis
Drug: Biaxin ( clarithromycin)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
October 2004
Not Provided

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
Sexes Eligible for Study: All
6 Years to 50 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Wake Forest University
Principal Investigator: Bruce K Rubin, MEngr,MD,MBA Wake Forest University Health Sciences
Wake Forest University Health Sciences
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP