NCT00205634

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2000

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

3.8 years

First QC Date

September 12, 2005

Last Update Submit

August 9, 2018

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis (CF)Macrolide antiobioticsairway inflammation

Outcome Measures

Primary Outcomes (2)

  • Pulmonary Function Testing - FEV1

  • Quality of Life

Secondary Outcomes (2)

  • decrease in neutrophil-dominated airway inflammation

  • decrease in Pseudomonas alginate production in vitro and in the airway

Interventions

Biaxin ( clarithromycin)DRUG

Eligibility Criteria

Age6 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • diagnosis of CF
  • ability to reliably perform spirometry
  • FEV1 of 30% predicted at the time of screening

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Clarithromycin

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Bruce K Rubin, MEngr,MD,MBA

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

December 1, 2000

Primary Completion

October 1, 2004

Study Completion

October 1, 2004

Last Updated

August 13, 2018

Record last verified: 2018-08

Locations

US(1)