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

InterMune51 enrolled

Overview

The purpose of this research study is to evaluate the safety, tolerability, and efficacy of Interferon gamma-1b (IFN-gamma 1b) when administered by subcutaneous injection over a period of 4 weeks to patients with mild-to-moderate cystic fibrosis. Additionally, preliminary assessments on the effects of IFN-gamma 1b on lung function and other indicators of health will be made.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cystic Fibrosis

Interventions

interferon gamma-1bDRUG

100 or 200 mcg, SQ, 3x per week

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

* At least 6 years of age * Diagnosis of cystic fibrosis (against certain criteria) * Able to perform pulmonary (lung) function tests and participate in induced sputum procedures * Pulmonary function values must meet certain minimal requirements * Must have acceptable laboratory test results * Cannot be on certain medications during and immediately prior to study * Cannot have a history of unstable or deteriorating cardiac or neurologic disease

Outcomes

Primary Outcomes

change in sputum neutrophil count

Time frame: 4 weeks

Secondary Outcomes

change in predicted FEV1, sputum bacterial density, sputum levels of free neutrophil elastase, DNA and IL-8

Time frame: 4 weeks

Data from ClinicalTrials.gov

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