An active surveillance to monitor the real world safety of Nintedanib in Indian Idiopathic Pulmonary Fibrosis (a type of lung disease in which tissue deep in our lungs becomes thick and stiff, or scarred, over the time) patients

Phase 4

Completed

• Conditions: Health Condition 1: null- Idiopathic Pulmonary Fibrosis

• Registration Number: CTRI/2017/02/007867
• Lead Sponsor: Boehringer Ingelheim India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-07-21
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 21

Inclusion Criteria

Patients with documented diagnosis of IPF based upon ATS ERS JRS ALAT 2011 guidelines

and who comply with inclusion and exclusion criteria will be included in this active

surveillance The diagnosis of IPF as per ATS ERS JRS ALAT 2011 guidelines requires

Exclusion of other known causes of ILD eg domestic and occupational environmental

exposures connective tissue disease and drug toxicity

The presence of a UIP pattern on HRCT in patients not subjected to surgical lung biopsy

Specific combinations of HRCT and surgical lung biopsy pattern in patients subjected to

surgical lung biopsy

Patients with IPF IPFtreatment naïve or pretreated who are newly prescribed nintedanib according to the package insert

Willing and able to provide the informed consent

Patients in whom further visit/contact is possible during the planned period of active

surveillance

In addition equal number of consecutive IPF patients with documented diagnosis of IPF

based upon ATS ERS JRS ALAT 2011 guidelines who will be newly prescribed pirfenidone

will be enrolled

Patients with IPF IPF treatment naïve or pretreated who are newly prescribed

pirfenidone

Willing and able to provide informed consent to collect the baseline characteristics

Exclusion Criteria

Patients who have taken nintedanib before participation in this active surveillance

Patients who are being treated with pirfenidone

Patients who are participating in a clinical trial or other IPF registries

In addition equal number of consecutive IPF patients with documented diagnosis of IPF

based upon ATS ERS JRS ALAT 2011 guidelines who will be newly prescribed pirfenidone

will be enrolled

Patients who have taken pirfenidone before participation in this active surveillance

Patients who are participating in a clinical trial or other IPF registries

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of ADRs serious and nonserious <br/ ><br>Occurrence of AEs serious and fatalTimepoint: 2 Years

Secondary Outcome Measures

Name	Time	Method
Percentage of patients who require dose reductions and discontinuation due to adverse <br/ ><br>eventsTimepoint: 2 years