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Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Biaxin ( clarithromycin)
Sponsored by
Wake Forest University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic Fibrosis (CF), Macrolide antiobiotics, airway inflammation

Eligibility Criteria

6 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Health Sciences

Outcomes

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

Full Information

First Posted
September 12, 2005
Last Updated
August 9, 2018
Sponsor
Wake Forest University
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00205634
Brief Title
Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis
Official Title
Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 2000 (Actual)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
October 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University
Collaborators
Abbott

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic Fibrosis (CF), Macrolide antiobiotics, airway inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Biaxin ( clarithromycin)
Primary Outcome Measure Information:
Title
Pulmonary Function Testing - FEV1
Title
Quality of Life
Secondary Outcome Measure Information:
Title
decrease in neutrophil-dominated airway inflammation
Title
decrease in Pseudomonas alginate production in vitro and in the airway

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce K Rubin, MEngr,MD,MBA
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

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Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis

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