Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Wake Forest School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Abbott
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00205634
First received: September 12, 2005
Last updated: December 13, 2007
Last verified: December 2007
  Purpose

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 Intervention
Cystic Fibrosis
Drug: Biaxin ( clarithromycin)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Pulmonary Function Testing - FEV1
  • Quality of Life

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

Estimated Enrollment: 50
Study Start Date: December 2000
Estimated Study Completion Date: October 2004
  Eligibility

Ages Eligible for Study:   6 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205634

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

No publications provided

ClinicalTrials.gov Identifier: NCT00205634     History of Changes
Other Study ID Numbers: BG99-486
Study First Received: September 12, 2005
Last Updated: December 13, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Cystic Fibrosis (CF)
Macrolide antiobiotics
airway inflammation

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014