Interferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic Fibrosis
Information source: InterMune
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis
Intervention: interferon gamma-1b (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: InterMune Official(s) and/or principal investigator(s):
Steve Porter, MD, Study Director, Affiliation: InterMune
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.
Clinical Details
Official title: A Phase I/II Study of Interferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic Fibrosis
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: change in FEV1, sputum bacterial density
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Birmingham, Alabama, United States
Phoenix, Arizona, United States
Palo Alto, California, United States
Sacramento, California, United States
San Diego, California, United States
San Francisco, California, United States
Denver, Colorado, United States
Daytona Beach, Florida, United States
Orlando, Florida, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Rochester, Minnesota, United States
New York City, New York, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Lackland AFB, Texas, United States
Tyler, Texas, United States
Additional Information
Starting date: February 2001
Ending date: October 2002
Last updated: October 29, 2007
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