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

  • End date
    Dec 31, 2022
  • participants needed
  • sponsor
    Boehringer Ingelheim
Updated on 25 July 2022
idiopathic pulmonary fibrosis


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.

Condition Idiopathic Pulmonary Fibrosis
Clinical Study IdentifierNCT03047031
SponsorBoehringer Ingelheim
Last Modified on25 July 2022


Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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