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

An Active Surveillance to Monitor the Real World Safety in Indian Patients Prescribed Nintedanib for the Treatment of 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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: Nintedanib; Drug: Pirfenidone

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• India
  • Jaipur, India, 302039
    • Asthma Bhawan
  • Kolkata, India, 700027
    • CK Birla Hospitals, The Calcutta Medical Research Institute
  • Kolkatta, India, 700017
    • National Allergy Asthma Bronchitis Institute, Kolkata
  • Lucknow, India, 226003
    • King George Medical University
  • Lucknow, India, 226006
    • Midland Healthcare and Research Centre
  • Mumbai, India, 400007
    • Bhatia Hospital
  • Mumbai, India, 400016
    • P.D. Hinduja National Hospital
  • Pune, India, 411001
    • Grant Medical Foundation, Ruby Hall Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This active surveillance will include all IPF patients treated with nintedanib per the inclusion/exclusion criteria at selected centres during the first two years after the commercial availability of the drug.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All nintedanib treated patients (group B + group C)	Drug: Nintedanib; Nintedanib
Group II- pirfenidone patients	Drug: Pirfenidone; Pirfenidone
Group III - pirfenidone patients	Drug: Pirfenidone; Pirfenidone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence Rate of All ADRs in Nintedanib Treated Patients	Incidence of all Adverse Drug Reactions (ADRs) in nintedanib treated patients is reported. An adverse reaction is defined as at least a reasonable possibility of a causal relationship between a suspected medicinal product and an adverse event. Incidence rate was calculated using the number of patients with ADRs events per treatment divided by time at risk expressed as [100 patient-years (pt-yrs)]. Time at risk was calculated as below: If patients with AE: Time at risk= (start date of first AE- start date of treatment administration) +1; If patients without AE: Time at risk= (end of date at risk (date of study completion or date of discontinuation or last visit date available)-start date of treatment administration) +1.	From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.
Incidence Rate of All SAEs in Nintedanib Treated Patients	Incidence rate of all Serious Adverse Events (SAEs) in nintedanib treated patients is reported. A SAE was defined as any adverse event which: results in death,; is life-threatening,; requires in-patient hospitalization, or; prolongation of existing hospitalisation,; results in persistent or significant disability or incapacity, or; is a congenital anomaly/birth defect. Incidence rate was calculated using the number of patients with SAEs events per treatment divided by time at risk expressed as [100 patient-years (pt-yrs)]. Time at risk was calculated as below: If patients with AE: Time at risk= (start date of first AE- start date of treatment administration) +1; If patients without AE: Time at risk= (end of date at risk (date of study completion or date of discontinuation or last visit date available)-start date of treatment administration) +1.	From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With AEs Leading to Permanent Dose Reductions of Study Drug	Percentage of patients with Adverse Events (AEs) leading to permanent dose reductions of study drug is reported.	From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.
Percentage of Patients With AEs Causing Dose Interruption of Study Drug	Percentage of patients with Adverse Events (AEs) causing dose interruption of study drug is reported.	From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.
Percentage of Patients With AEs Leading to Permanently Discontinuation of Study Drug	Percentage of patients with adverse events (AEs) leading to permanently discontinuation of study drug is reported. Percentages are rounded to one decimal places.	From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2017
• Primary Completion (Actual): July 21, 2022
• Study Completion (Actual): July 21, 2022

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Estimated): February 8, 2017

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Protein Kinase Inhibitors; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Pirfenidone; Nintedanib
• Other Study ID Numbers: 1199-0280

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

• IPD Sharing Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• IPD Sharing Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No