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

Sponsor:

Collaborator:

Abbott

Information provided by:

Wake Forest University

ClinicalTrials.gov Identifier:

NCT00205634

First received: September 12, 2005

Last updated: December 13, 2007

Last verified: December 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

December 13, 2007

Start Date ^ICMJE

December 2000

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Pulmonary Function Testing - FEV1
Quality of Life

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00205634 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

decrease in neutrophil-dominated airway inflammation
decrease in Pseudomonas alginate production in vitro and in the airway

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis

Official Title ^ICMJE

Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Cystic Fibrosis

Intervention ^ICMJE

Drug: Biaxin ( clarithromycin)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

October 2004

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00205634

Other Study ID Numbers ^ICMJE

BG99-486

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Wake Forest University

Collaborators ^ICMJE

Abbott

Investigators ^ICMJE

Principal Investigator:

Bruce K Rubin, MEngr,MD,MBA

Wake Forest University

Information Provided By

Wake Forest University

Verification Date

December 2007

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

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