Conditions: Idiopathic Pulmonary Fibrosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 113
Healthy volunteers: no

Brief summary:
This is an 6 month multi-centre, prospective, randomized, placebo controlled, double blind clinical trial followed by conversion of each arm to active nintedanib for an additional 6 months comparing the effect of nintedanib 150mg bis in die (BID twice daily) on the progression of IPF measured by using High Resolution Computerized Tomography(HRCT), lung function, functional component (6MWT), biomarkers, and PRO component (PROs) with continued treatment and assessments for up to 18 months.

Detailed description:

Arms:
arm 1: 150 mg twice daily arm 2: twice daily dosing

Interventions: intervention 1: Matching Placebo intervention 2: Nintedanib
Intervention descriptions: intervention 1: twice daily dosing intervention 2: gelating capsule

Protocol document: