Cystic Fibrosis
Conditions
Keywords
cystic fibrosis, pulmonary impairment
Brief summary
The purpose of this research study is to evaluate the safety, tolerability, and efficacy of Interferon gamma-1b (IFN-gamma 1b) when administered by subcutaneous injection over a period of 4 weeks to patients with mild-to-moderate cystic fibrosis. Additionally, preliminary assessments on the effects of IFN-gamma 1b on lung function and other indicators of health will be made.
Interventions
DRUGinterferon gamma-1b
100 or 200 mcg, SQ, 3x per week
Sponsors
InterMune
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 6 years of age * Diagnosis of cystic fibrosis (against certain criteria) * Able to perform pulmonary (lung) function tests and participate in induced sputum procedures * Pulmonary function values must meet certain minimal requirements * Must have acceptable laboratory test results * Cannot be on certain medications during and immediately prior to study * Cannot have a history of unstable or deteriorating cardiac or neurologic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in sputum neutrophil count | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| change in predicted FEV1, sputum bacterial density, sputum levels of free neutrophil elastase, DNA and IL-8 | 4 weeks |
Outcome results
None listed