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

NCT ID: NCT00043316

Last Updated: 2007-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2002-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cystic Fibrosis

Keywords

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cystic fibrosis pulmonary impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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interferon gamma-1b

500 or 1000 mcg, inhalation, 3x per week

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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InterMune

INDUSTRY

Sponsor Role lead

Principal Investigators

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Steve Porter, MD

Role: STUDY_DIRECTOR

InterMune

Locations

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Birmingham, Alabama, United States

Site Status

Phoenix, Arizona, United States

Site Status

Palo Alto, California, United States

Site Status

Sacramento, California, United States

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San Diego, California, United States

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San Francisco, California, United States

Site Status

Denver, Colorado, United States

Site Status

Daytona Beach, Florida, United States

Site Status

Orlando, Florida, United States

Site Status

Chicago, Illinois, United States

Site Status

New Orleans, Louisiana, United States

Site Status

Rochester, Minnesota, United States

Site Status

New York, New York, United States

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Philadelphia, Pennsylvania, United States

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Nashville, Tennessee, United States

Site Status

Lackland Air Force Base, Texas, United States

Site Status

Tyler, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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GICF-001

Identifier Type: -

Identifier Source: org_study_id