NCT02598193

Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF)

An Exploratory Multicenter, Open-Label, Single Arm Study of the Safety and Tolerability of Pirfenidone (Esbriet®) in Combination With Nintedanib (Ofev®) in Patients With Idiopathic Pulmonary Fibrosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This clinical study will evaluate the safety and tolerability of combination treatment of nintedanib and pirfenidone in participants with IPF. Eligible participants must have received pirfenidone for at least 16 weeks on a stable dose. Nintedanib will be added on Day 1 of the study as a combination treatment for IPF for 24 weeks.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	Nintedanib	Participants with IPF will receive nintedanib at the 200-300 mg/day dose up to 24 weeks.
DRUG	Pirfenidone	Participants with IPF will receive pirfenidone at 1602-2403 mg/day dose up to 24 weeks.

Timeline

• Start date: 2016-01-14
• Primary completion: 2017-05-16
• Completion: 2017-05-16
• First posted: 2015-11-05
• Last updated: 2018-06-13
• Results posted: 2018-06-13

Locations

38 sites across 8 countries: United States, Canada, Denmark, France, Germany, Italy, Netherlands, Spain

Regulatory

• FDA-regulated drug study