Post Marketing Surveillance of Nintedanib in Indian Patients With Idiopathic Pulmonary Fibrosis

Boehringer Ingelheim

Status

Completed

Conditions

Idiopathic Pulmonary Fibrosis

Treatments

Drug: Nintedanib

Drug: Pirfenidone

Study type

Observational

Funder types

Industry

Identifiers

NCT03047031

1199-0280

Details and patient eligibility

About

This is an active surveillance study to monitor the real world safety of nintedanib in Indian patients with Idiopathic Pulmonary Fibrosis. The safety of nintedanib has been assessed in clinical trials.This active surveillance aims to collect the safety data of 200 IPF patients treated with nintedanib in approved indication after the commercial availability of the drug in India (23rd January 2017). The objective is to look at safety of nintedanib in the real world setting.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with documented diagnosis of Idiopathic Pulmonary Fibrosis (IPF) based upon ATS/ERS/JRS/ALAT 2011 guidelines (nintedanib naïve or pirfenidone pre-treated) who have initiated or will initiate nintedanib according to the package insert after the commercial availability of drug in India (23rd January 2017).
Patients in whom it is possible to obtain voluntary informed consent either from the patient or patient's legally authorised representative (applicable for Group B and C patients).
Patients in whom data collection is possible from the medical records (applicable for Group A and B patients)
Further inclusion criteria apply

Exclusion criteria

Patients who were previously treated with nintedanib.
Patients who have initiated or will initiate nintedanib concomitantly with pirfenidone..
Patients who are participating in a clinical trial.
Further exclusion criteria apply.