Conditions: Idiopathic Pulmonary Fibrosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 105
Healthy volunteers: no

Brief summary:
This is a phase IV, twelve week, open label, randomized, parallel group study to assess safety and tolerability of combined treatment with nintedanib and pirfenidone.

A secondary objective is to assess the exposure based on PK trough concentration values to nintedanib either given alone or in combination with pirfenidone and to assess the exposure of pirfenidone when combined with nintedanib.

Detailed description:

Arms:
arm 1: Nintedanib 150 mg bid arm 2: Nintedanib 150 mg bid combined with pirfenidone up to 801 mg tid

Interventions: intervention 1: Nintedanib intervention 2: Pirfenidone
Intervention descriptions: intervention 1: Nintedanib 150mg bid intervention 2: None

Protocol document: