Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Wake Forest School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Abbott
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00205634
First received: September 12, 2005
Last updated: December 13, 2007
Last verified: December 2007

September 12, 2005
December 13, 2007
December 2000
Not Provided
  • 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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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.
 
Active, not recruiting
50
October 2004
Not Provided

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
Both
6 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00205634
BG99-486
Not Provided
Not Provided
Wake Forest School of Medicine
Abbott
Principal Investigator: Bruce K Rubin, MEngr,MD,MBA Wake Forest School of Medicine
Wake Forest School of Medicine
December 2007

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