Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Drug: Biaxin ( clarithromycin)

• Study Type: Interventional
• Enrollment: 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Quality of Life
Pulmonary Function Testing - FEV1

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wake Forest University
• Collaborators: Abbott
• Investigators: Principal Investigator: Bruce K Rubin, MEngr,MD,MBA, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2000
• Primary Completion (Actual): October 1, 2004
• Study Completion (Actual): October 1, 2004

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Actual): August 13, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: airway inflammation; Cystic Fibrosis (CF); Macrolide antiobiotics
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Clarithromycin
• Other Study ID Numbers: BG99-486

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No