Back to resultsInterferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
interferon gamma-1b
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring cystic fibrosis, pulmonary impairment
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
change in FEV1, sputum bacterial density
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00043316
Brief Title
Interferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic Fibrosis
Official Title
A Phase I/II Study of Interferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
InterMune
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
cystic fibrosis, pulmonary impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
interferon gamma-1b
Intervention Description
500 or 1000 mcg, inhalation, 3x per week
Primary Outcome Measure Information:
Title
change in FEV1, sputum bacterial density
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Porter, MD
Organizational Affiliation
InterMune
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Palo Alto
State/Province
California
Country
United States
City
Sacramento
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
San Francisco
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Daytona Beach
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
City
Rochester
State/Province
Minnesota
Country
United States
City
New York City
State/Province
New York
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Lackland AFB
State/Province
Texas
Country
United States
City
Tyler
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Interferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic Fibrosis
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