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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-05

Study Completion Date

2022-07-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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All nintedanib treated patients (group B + group C)

Nintedanib

Intervention Type DRUG

Nintedanib

Group II- pirfenidone patients

Pirfenidone

Intervention Type DRUG

Pirfenidone

Group III - pirfenidone patients

Pirfenidone

Intervention Type DRUG

Pirfenidone

Interventions

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Nintedanib

Intervention Type DRUG

Pirfenidone

Intervention Type DRUG

Eligibility Criteria

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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)

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No