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

This study has been completed.
Sponsor:
Information provided by:
InterMune
ClinicalTrials.gov Identifier:
NCT00043316
First received: August 7, 2002
Last updated: October 29, 2007
Last verified: October 2007
  Purpose

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 Intervention Phase
Cystic Fibrosis
Drug: interferon gamma-1b
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by InterMune:

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

Enrollment: 66
Study Start Date: February 2001
Study Completion Date: October 2002
Intervention Details:
    Drug: interferon gamma-1b
    500 or 1000 mcg, inhalation, 3x per week
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00043316     History of Changes
Other Study ID Numbers: GICF-001
Study First Received: August 7, 2002
Last Updated: October 29, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by InterMune:
cystic fibrosis
pulmonary impairment

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

ClinicalTrials.gov processed this record on November 20, 2014