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

This study has been completed.

First Received: August 7, 2002 Last Updated: October 29, 2007 History of Changes

Sponsored by:	InterMune
Information provided by:	InterMune
ClinicalTrials.gov Identifier:	NCT00043316

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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Interferon gamma-1b Interferons

U.S. FDA Resources

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:

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

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

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

Keywords provided by InterMune:

cystic fibrosis
pulmonary impairment

Study placed in the following topic categories:

Anti-Infective Agents
Interferon Type II
Fibrosis
Interferons
Antiviral Agents
Digestive System Diseases
Cystic Fibrosis

Respiratory Tract Diseases
Genetic Diseases, Inborn
Lung Diseases
Pancreatic Diseases
Infant, Newborn, Diseases
Interferon-gamma, Recombinant

Additional relevant MeSH terms:

Anti-Infective Agents
Interferon Type II
Antineoplastic Agents
Fibrosis
Interferons
Antiviral Agents
Pharmacologic Actions
Digestive System Diseases
Pathologic Processes

Cystic Fibrosis
Respiratory Tract Diseases
Genetic Diseases, Inborn
Therapeutic Uses
Lung Diseases
Pancreatic Diseases
Infant, Newborn, Diseases
Interferon-gamma, Recombinant

ClinicalTrials.gov processed this record on September 10, 2009