Interferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic Fibrosis
A Phase I/II Study of Interferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic Fibrosis
1 other identifier
interventional
66
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2001
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2001
CompletedFirst Submitted
Initial submission to the registry
August 7, 2002
CompletedFirst Posted
Study publicly available on registry
August 9, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2002
CompletedNovember 1, 2007
October 1, 2007
August 7, 2002
October 29, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in FEV1, sputum bacterial density
12 weeks
Interventions
500 or 1000 mcg, inhalation, 3x per week
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- InterMunelead
Study Sites (17)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Palo Alto, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Daytona Beach, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
New Orleans, Louisiana, United States
Unknown Facility
Rochester, Minnesota, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Lackland Air Force Base, Texas, United States
Unknown Facility
Tyler, Texas, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Steve Porter, MD
InterMune
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 7, 2002
First Posted
August 9, 2002
Study Start
February 1, 2001
Study Completion
October 1, 2002
Last Updated
November 1, 2007
Record last verified: 2007-10