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INPULSIS-1: Nintedanib in IPF
NCT01335464Phase 3
Key facts
- Status
- Completed
- Start
- Apr 2011
- Primary completion
- Oct 2013
- Countries
- 13
- Sponsor
- Boehringer Ingelheim
- Modality
- Fragment-Derived Small Molecules, Allosteric Modulators, Orthosteric Ligands
- Drugs
- nintedanib
- Conditions
- idiopathic pulmonary fibrosis (IPF)
01
Overview
Phase 3, randomised, double-blind trial in idiopathic pulmonary fibrosis (IPF) comparing Nintedanib with Placebo (2 arms). Primary endpoint: Annual Rate of Decline in Forced Vital Capacity at 52 weeks. Started Apr 2011; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Nintedanib
Nintedanib 150 mg BID
Placebo
Placebo matching Nintedanib
03
Who it enrols
Patients aged 40 or older with a diagnosis of IPF within 5 years, FVC >= 50% predicted, and DLCO 30-79% predicted. Excludes patients with liver enzyme elevations, bleeding/thrombotic risk, recent MI/unstable angina, or recent use of pirfenidone, azathioprine, cyclophosphamide, or cyclosporine A.
04
Endpoints
Primary
Annual Rate of Decline in Forced Vital Capacity
Secondary
Change From Baseline in Saint-George's Respiratory Questionnaire Total Score
Time to First Acute Idiopathic Pulmonary Fibrosis Exacerbation
Absolute Change From Baseline in Forced Vital Capacity
Time to Death Over 52 Weeks
05
Results
Primary endpoints met
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