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

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ClinicalTrials.gov Identifier: NCT00043316
Recruitment Status : Completed
First Posted : August 9, 2002
Last Update Posted : November 1, 2007
Sponsor:
Information provided by:
InterMune

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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: interferon gamma-1b Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Interferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic Fibrosis
Study Start Date : February 2001
Actual Study Completion Date : October 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources


Intervention Details:
    Drug: interferon gamma-1b
    500 or 1000 mcg, inhalation, 3x per week


Primary Outcome Measures :
  1. change in FEV1, sputum bacterial density [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00043316


Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
United States, California
Palo Alto, California, United States
Sacramento, California, United States
San Diego, California, United States
San Francisco, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Florida
Daytona Beach, Florida, United States
Orlando, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Minnesota
Rochester, Minnesota, United States
United States, New York
New York City, New York, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Lackland AFB, Texas, United States
Tyler, Texas, United States
Sponsors and Collaborators
InterMune
Investigators
Study Director: Steve Porter, MD InterMune

ClinicalTrials.gov Identifier: NCT00043316     History of Changes
Other Study ID Numbers: GICF-001
First Posted: August 9, 2002    Key Record Dates
Last Update Posted: November 1, 2007
Last Verified: October 2007

Keywords provided by InterMune:
cystic fibrosis
pulmonary impairment

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Interferons
Interferon-gamma
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents