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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03047031
Recruitment Status : Recruiting
First Posted : February 8, 2017
Last Update Posted : June 12, 2018
Information provided by (Responsible Party):
Boehringer Ingelheim

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. Since only 20 patients from India were enrolled in the INPULSIS trials, the safety data on Indian patients is limited. In this active surveillance, the safety of nintedanib in IPF patients will be examined in Indian real world setting

Condition or disease
Idiopathic Pulmonary Fibrosis

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: An Active Surveillance to Monitor the Real World Safety in Indian Patients Prescribed Nintedanib for the Treatment of Idiopathic Pulmonary Fibrosis
Actual Study Start Date : April 6, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

subjects being prescribed with Nintedanib

Primary Outcome Measures :
  1. Occurrence of Adverse Drug Reactions (serious and non-serious) [ Time Frame: up to 56 weeks ]
  2. Occurrence of SAEs (serious adverse events) [ Time Frame: up to 56 weeks ]

Secondary Outcome Measures :
  1. Percentage of patients who require dose reductions and discontinuation due to adverse events [ Time Frame: up to 56 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 approximately 30 selected centres during the first two years after the commercial availability of the drug.

Inclusion Criteria:

  • Patients with IPF (IPF-treatment naïve or pre-treated) 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.
  • Further inclusion criteria apply

Exclusion Criteria:

  • Patients who have taken nintedanib before participation in this active surveillance.
  • Patients who are planned to be concomitantly treated with Pirfenidone.
  • Patients who are participating in a clinical trial or other IPF registries.
  • Further exclusion criteria apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03047031

Contact: Boehringer Ingelheim 1-800-243-0127

St. Johns medical College and Hospital Recruiting
Bangalore, India, 560034
Contact: Priya Ramachandra    9663590386   
National Allergy Asthma Bronchitis Institute, Kolkata Recruiting
Kolkatta, India, 700017
Contact: Alok Gopal Ghoshal    91-9830068023   
Sponsors and Collaborators
Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim Identifier: NCT03047031     History of Changes
Other Study ID Numbers: 1199-0280
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action