Cystic Fibrosis
Conditions
Keywords
cystic fibrosis, pulmonary impairment
Brief summary
The purpose of this research study is to evaluate the safety and effectiveness of Interferon gamma-1b (IFN-g 1b) on lung function when given to patients with cystic fibrosis by inhalation (breathed into the lungs) three times a week for 12 weeks. The FDA has not approved Interferon gamma-1b for use with cystic fibrosis patients, which is the condition being examined in this study.
Interventions
DRUGinterferon gamma-1b
500 or 1000 mcg, inhalation, 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
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key inclusion criteria: * At least 12 years of age * Diagnosis of cystic fibrosis with mild to moderate pulmonary impairment * Must be receiving ongoing chronic treatment with TOBI (inhaled tobramycin) OR not receiving ongoing chronic treatment with TOBI and no use of TOBI or other inhaled antibiotic within 4 weeks prior to study drug administration· * Other specific diagnostic indicators of CF and other factors must meet minimum requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in FEV1, sputum bacterial density | 12 weeks |
Countries
United States
Outcome results
None listed