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Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT00205634
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : August 10, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Cystic Fibrosis Drug: Biaxin ( clarithromycin)

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis
Actual Study Start Date : December 2000
Primary Completion Date : October 2004
Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Pulmonary Function Testing - FEV1
  2. Quality of Life

Secondary Outcome Measures :
  1. decrease in neutrophil-dominated airway inflammation
  2. decrease in Pseudomonas alginate production in vitro and in the airway

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00205634

United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
Principal Investigator: Bruce K Rubin, MEngr,MD,MBA Wake Forest University Health Sciences
More Information

Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT00205634     History of Changes
Other Study ID Numbers: BG99-486
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
Cystic Fibrosis (CF)
Macrolide antiobiotics
airway inflammation

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors