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

An active surveillance to monitor the real world safety in Indian patients prescribed nintedanib for the treatment of Idiopathic Pulmonary Fibrosis - PASS IPF

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2017/02/007867

Enrollment

100

Registered

2017-02-14

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Idiopathic Pulmonary Fibrosis

Interventions

Intervention1: Nintedanib: This is not interventional study. This is an active surveillance is based on new data collection to gather real world information i e data under routine medical practice on

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Occurrence of ADRs serious and nonserious Occurrence of AEs serious and fatalTimepoint: 2 Years	—

Secondary

Measure	Time frame
Percentage of patients who require dose reductions and discontinuation due to adverse eventsTimepoint: 2 years	—

Countries

India

Contacts

Public ContactRaj Kumar

Boehringer Ingelheim India Pvt Ltd

rajesh.naik@boehringer-ingelheim.com912271456633

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026