Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205634
• Other study ID #: BG99-486
• Status: Completed
• Phase: Phase 2
• Start date: December 2000
• Est. completion date: October 2004

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2004
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Biaxin ( clarithromycin)

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Function Testing - FEV1
Primary	Quality of Life
Secondary	decrease in neutrophil-dominated airway inflammation
Secondary	decrease in Pseudomonas alginate production in vitro and in the airway