NCT00075998

The INSPIRE Trial: A Study of Interferon Gamma-1b for Idiopathic Pulmonary Fibrosis (IPF)

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)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 826 (actual)
• Sponsor: InterMune · Industry
• Sex: All
• Age: 40 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Pulmonary Fibrosis
• Lung Disease
• Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	Interferon gamma-1b ("Actimmune")	200 mcg, SQ, 3x per week

Timeline

• Start date: 2003-12-01
• Completion: 2007-05-01
• First posted: 2004-01-14
• Last updated: 2009-07-02

Locations

1 site across 1 country: United States