Cystic Fibrosis
Conditions
Keywords
Cystic Fibrosis (CF), Macrolide antiobiotics, airway inflammation
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.
Interventions
DRUGBiaxin ( clarithromycin)
Sponsors
Abbott
Wake Forest University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
6 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary Function Testing - FEV1 | — |
| Quality of Life | — |
Secondary
| Measure | Time frame |
|---|---|
| decrease in neutrophil-dominated airway inflammation | — |
| decrease in Pseudomonas alginate production in vitro and in the airway | — |
Countries
United States
Outcome results
None listed