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OpenTrials
Completed

NCT Number: NCT00205634

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

6 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biaxin ( clarithromycin)

Drug

Primary outcomes

  1. Pulmonary Function Testing - FEV1

  2. Quality of Life

Secondary outcomes

  1. decrease in neutrophil-dominated airway inflammation

  2. decrease in Pseudomonas alginate production in vitro and in the airway

Sponsors and collaborators

Lead sponsor

Wake Forest University

Other

Collaborators

  • Abbott

Registry information

Important dates

Study start
2000
Primary completion
2004
Study completion
2004
First posted
Sep 20, 2005
Registry last updated
Aug 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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