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Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00205634
First Posted: September 20, 2005
Last Update Posted: August 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Abbott
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )
September 12, 2005
September 20, 2005
August 10, 2017
December 2000
October 2004   (Final data collection date for primary outcome measure)
  • Pulmonary Function Testing - FEV1
  • Quality of Life
Same as current
Complete list of historical versions of study NCT00205634 on ClinicalTrials.gov Archive Site
  • decrease in neutrophil-dominated airway inflammation
  • decrease in Pseudomonas alginate production in vitro and in the airway
Same as current
Not Provided
Not Provided
 
Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Cystic Fibrosis
Drug: Biaxin ( clarithromycin)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
October 2004
October 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Years to 50 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00205634
BG99-486
Not Provided
Not Provided
Not Provided
Wake Forest University Health Sciences ( Wake Forest University )
Wake Forest University
Abbott
Principal Investigator: Bruce K Rubin, MEngr,MD,MBA Wake Forest University Health Sciences
Wake Forest University Health Sciences
August 2017

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