Interferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic Fibrosis

InterMune

Status and phase

Completed

Phase 2

Phase 1

Conditions

Cystic Fibrosis

Treatments

Drug: interferon gamma-1b

Study type

Interventional

Funder types

Industry

Identifiers

NCT00043316

GICF-001

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.