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

October 29, 2007 updated by: InterMune

A Phase I/II Study of Interferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic Fibrosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • Palo Alto, California, United States
      • Sacramento, California, United States
      • San Diego, California, United States
      • San Francisco, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Florida
      • Daytona Beach, Florida, United States
      • Orlando, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Minnesota
      • Rochester, Minnesota, United States
    • New York
      • New York City, New York, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Lackland AFB, Texas, United States
      • Tyler, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in FEV1, sputum bacterial density
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InterMune

Investigators

  • Study Director: Steve Porter, MD, InterMune

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Study Completion (Actual)

October 1, 2002

Study Registration Dates

First Submitted

August 7, 2002

First Submitted That Met QC Criteria

August 8, 2002

First Posted (Estimate)

August 9, 2002

Study Record Updates

Last Update Posted (Estimate)

November 1, 2007

Last Update Submitted That Met QC Criteria

October 29, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GICF-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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