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

NCT03047031 | Completed Results

• 1 other identifier: 1199-0280
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Percentage of Patients With AEs Leading to Permanent Dose Reductions of Study Drug

  From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.

• Percentage of Patients With AEs Causing Dose Interruption of Study Drug

  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

  From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.

Study Arms (3)

All nintedanib treated patients (group B + group C)

Drug: Nintedanib

Group II- pirfenidone patients

Drug: Pirfenidone

Group III - pirfenidone patients

Drug: Pirfenidone

Interventions

Nintedanib DRUG

Nintedanib

All nintedanib treated patients (group B + group C)

Pirfenidone DRUG

Pirfenidone

Group II- pirfenidone patients; Group III - pirfenidone patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (8)

Asthma Bhawan

Jaipur, 302039, India

Location

National Allergy Asthma Bronchitis Institute, Kolkata

Kolkata, 700017, India

Location

CK Birla Hospitals, The Calcutta Medical Research Institute

Kolkata, 700027, India

Location

King George Medical University

Lucknow, 226003, India

Location

Midland Healthcare and Research Centre

Lucknow, 226006, India

Location

Bhatia Hospital

Mumbai, 400007, India

Location

P.D. Hinduja National Hospital

Mumbai, 400016, India

Location

Grant Medical Foundation, Ruby Hall Clinic

Pune, 411001, India

Location

Related Links

• Related Info

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

nintedanib; pirfenidone

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 8, 2017
• Study Start: April 5, 2017
• Primary Completion: July 21, 2022
• Study Completion: July 21, 2022
• Last Updated: May 16, 2025
• Results First Posted: August 22, 2024

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (8)