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

Not Applicable

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Registration Number: CTRI/2017/02/007867

Lead Sponsor: Boehringer Ingelheim India Pvt Ltd

Brief Summary: This active surveillance is based on new data collection to gather real-world information i e data under routine medical practice) on safety of the nintedanib treatment in IPF patients in Indian real world setting.

It will include all IPF patients who have been newly prescribed nintedanib according to the approved Indian label during the first two years from the date of commercial availability of the drug.

In addition consecutive IPF patients who will be newly prescribed pirfenidone will also be registered from the same centres during the same time period. The number of the patients enrolled in pirfenidone arm will be equal to the number of patients in the nintedanib arm

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

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 naÃ¯ve 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 naÃ¯ve 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 AEs serious and fatal	2 Years
Occurrence of ADRs serious and nonserious	2 Years

Secondary Outcome Measures

Name	Time	Method
Percentage of patients who require dose reductions and discontinuation due to adverse	events

Trial Locations

Locations (1): National Allergy Asthma Bronchitis Institute
🇮🇳
Kolkata, WEST BENGAL, India
National Allergy Asthma Bronchitis Institute
🇮🇳Kolkata, WEST BENGAL, India
Dr Aloke Ghoshal
Principal investigator
03322902305
agghosal@yahoo.com