Post Marketing Surveillance of Nintedanib in Indian Patients With Idiopathic Pulmonary Fibrosis
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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. |
ClinicalTrials.gov Identifier: NCT03047031 |
Recruitment Status :
Recruiting
First Posted : February 8, 2017
Last Update Posted : June 16, 2022
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Condition or disease |
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Idiopathic Pulmonary Fibrosis |
Study Type : | Observational |
Estimated Enrollment : | 400 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 5, 2017 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | December 31, 2022 |

Group/Cohort |
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Group A
Patients who started treatment with nintedanib after 23rd January, 2017 and have permanently discontinued the drug (as decided by the investigator) at the time of participation in the active surveillance.
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Group B
Patients who started treatment with nintedanib after 23rd January, 2017 and are continuing the drug at the time of participation in the active surveillance.
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Group C
Patients who have been newly prescribed nintedanib at the time of participation in the active surveillance
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- Incidence of all Adverse Drug Reactions (ADRs) in nintedanib treated patients [ Time Frame: up to 56 weeks ]
- Incidence of all serious adverse events (SAEs) in nintedanib treated patients [ Time Frame: up to 56 weeks ]
- Percentage of patients who require dose reductions, interruptions 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 |
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.

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 ClinicalTrials.gov identifier (NCT number): NCT03047031
Contact: Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
India | |
Gleneagles Global Hospital | Recruiting |
Chennai, India, 600100 | |
Contact: Boehringer Ingelheim 0008000501442 india@bitrialsupport.com | |
Sri Ramakrishna Hospital | Recruiting |
Coimbatore, India, 641044 | |
Contact: Boehringer Ingelheim 0008000501442 india@bitrialsupport.com | |
Asthma Bhawan | Recruiting |
Jaipur, India, 302039 | |
Contact: Boehringer Ingelheim 0008000501442 india@bitrialsupport.com | |
CK Birla Hospitals, The Calcutta Medical Research Institute | Recruiting |
Kolkata, India, 700027 | |
Contact: Boehringer Ingelheim 0008000501442 india@bitrialsupport.com | |
National Allergy Asthma Bronchitis Institute, Kolkata | Recruiting |
Kolkatta, India, 700017 | |
Contact: Boehringer Ingelheim 0008000501442 india@bitrialsupport.com | |
King George Medical University | Recruiting |
Lucknow, India, 226003 | |
Contact: Boehringer Ingelheim 0008000501442 india@bitrialsupport.com | |
Midland Healthcare and Research Centre | Recruiting |
Lucknow, India, 226006 | |
Contact: Boehringer Ingelheim 0008000501442 india@bitrialsupport.com | |
Bhatia Hospital | Recruiting |
Mumbai, India, 400007 | |
Contact: Boehringer Ingelheim 0008000501442 india@bitrialsupport.com | |
P.D. Hinduja National Hospital | Recruiting |
Mumbai, India, 400016 | |
Contact: Boehringer Ingelheim 0008000501442 india@bitrialsupport.com | |
Grant Medical Foundation, Ruby Hall Clinic | Recruiting |
Pune, India, 411001 | |
Contact: Boehringer Ingelheim 0008000501442 india@bitrialsupport.com |
Responsible Party: | Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT03047031 |
Other Study ID Numbers: |
1199-0280 |
First Posted: | February 8, 2017 Key Record Dates |
Last Update Posted: | June 16, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
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. |
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'. |
URL: | https://www.mystudywindow.com/msw/datasharing |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis |
Pathologic Processes Lung Diseases Respiratory Tract Diseases |