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



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

For Condition: Idiopathic Pulmonary Fibrosis,Lung Disease,Pulmonary Fibrosis
Status: Recruiting
Sponsor(s): InterMune ,
Synopsis: - 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: 600 patients will be enrolled from approximately 70 centers in North America and Europe - Randomization: 2:1 active-to-placebo ratio - Duration: 2 years active drug or placebo (rescue therapy will be permitted for patients who meet predefined criteria)
Details: INSPIRE, the largest and most comprehensive clinical trial ever conducted in IPF, is now enrolling patients with mild to moderate IPF. Eligible patients will receive either Interferon gamma-1b or placebo for a minimum of 2 years.
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 40 Years/79 Years
Genders: Both
Protocol Entry Criteria: - Ages 40-79 - Diagnosis of IPF based on ATS/ERS criteria within past 36 months - Definite or probable IPF on high-resolution computed tomography (HRCT) - Surgical lung biopsy or nondiagnostic bronchoscopy - Evidence of disease progression within past year - FVC within 55-90% of predicted value - DLCO within 35-90% of predicted value
Total Enrollment: 600

Location and Contact Information:

InterMune, Inc. *Recruiting*
Brisbane,  California,  94005
United States
Recruiting INSPIRE  Trial


Additional Information:
Study ID Numbers:
  GIPF-007; 
Study Start Date: December 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075998

Other Idiopathic Pulmonary Fibrosis Studies:
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2. Evaluation and Treatment of Patients with Lung Disease not Participating in Research

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4. Natrecor in Pulmonary Hypertension

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