A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis (The INSPIRE Trial)

InterMune1 site in 1 country826 target enrollmentDecember 2003

ConditionsIdiopathic Pulmonary Fibrosis Lung Disease Pulmonary Fibrosis

DrugsInterferon gamma-1b ("Actimmune")

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Idiopathic Pulmonary Fibrosis
Sponsor: InterMune
Enrollment: 826
Locations: 1
Primary Endpoint: Survival time from randomization to treatment completion visit, or, end of treatment period, or, last known vital status.
Status: Terminated
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Purpose: A phase 3, randomized, double-blind, placebo-controlled trial to determine the efficacy and safety of 200 µg of recombinant Interferon gamma-1b administered by subcutaneous (SC) injection, compared with placebo, in patients with IPF
Enrollment: Approximately 800 patients will be enrolled from approximately 80 centers in North America and Europe
Randomization: 2:1 active-to-placebo ratio
Duration: at least 2 years active drug or placebo (rescue therapy will be permitted for patients who meet predefined criteria)

Detailed Description

INSPIRE, the largest and most comprehensive clinical trial ever conducted in IPF, has now completed enrolling patients with mild to moderate IPF. Eligible patients will receive either Interferon gamma-1b or placebo for a minimum of 2 years.

Registry

clinicaltrials.gov

Start Date

December 2003

End Date

May 2007

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

InterMune

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Survival time from randomization to treatment completion visit, or, end of treatment period, or, last known vital status.

Time Frame: 3.5 years

Secondary Outcomes

Lung transplant-free survival time (ongoing assessment up to end of study).(3.5 years)
Total number of days without hospitalization resulting from respiratory admission diagnosis (ongoing assessment up to end of study).(3.5 years)
Changes from baseline measurement to week 96 measurement in the following (measured every 24 weeks): 6-minute walk test, shortness of breath(96 weeks)