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 University. Recruitment status was Active, not recruiting

First Received on September 12, 2005. Last Updated on December 13, 2007 History of Changes

Sponsor:	Wake Forest University
Collaborator:	Abbott
Information provided by:	Wake Forest University
ClinicalTrials.gov Identifier:	NCT00205634

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:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Antibiotics Cystic Fibrosis

Drug Information available for: Clarithromycin

U.S. FDA Resources

Further study details as provided by Wake Forest University:

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

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 University

Abbott

Investigators

Principal Investigator:

Bruce K Rubin, MEngr,MD,MBA

Wake Forest University

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 University:

Cystic Fibrosis (CF)
Macrolide antiobiotics
airway inflammation

Additional relevant MeSH terms:

Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

Anti-Bacterial Agents
Clarithromycin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012