Idiopathic Pulmonary FibrosisNCT03047031
Post Marketing Surveillance of Nintedanib in Indian Patients With Idiopathic Pulmonary Fibrosis
An observational study of Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 8 sites in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Nintedanib and Pirfenidone
- How many people
- 21 participants
- Where
- 8 sitesIndia
- Study dates
- 5 Apr 2017to 21 Jul 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
India8 sites
Asthma Bhawan
Jaipur, 302039
National Allergy Asthma Bronchitis Institute, Kolkata
Kolkata, 700017
CK Birla Hospitals, The Calcutta Medical Research Institute
Kolkata, 700027
King George Medical University
Lucknow, 226003
Midland Healthcare and Research Centre
Lucknow, 226006
Bhatia Hospital
Mumbai, 400007
P.D. Hinduja National Hospital
Mumbai, 400016
Grant Medical Foundation, Ruby Hall Clinic
Pune, 411001
About this study
Official title: 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Nintedanib, Pirfenidone
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NintedanibDrug
Nintedanib
PirfenidoneDrug
Pirfenidone
| Study group | Role | What they receive |
|---|---|---|
| All nintedanib treated patients (group B + group C) | Not described Receives: Drug: Nintedanib | |
| Group II- pirfenidone patients | Not described Receives: Drug: Pirfenidone | |
| Group III - pirfenidone patients | Not described Receives: Drug: Pirfenidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Percentage of patients with Adverse Events (AEs) leading to permanent dose reductions of study drug is reported.
Measured: 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.
Measured: 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.
Measured: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start5 Apr 2017
- Primary completion21 Jul 2022
- Study completion21 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047031
- Sponsor's protocol ID
- 1199-0280
- Status last verified
- May 2025
- First submitted
- 7 Feb 2017
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Active Surveillance to Monitor the Real World Safety in Indian Patients Prescribed Nintedanib for the Treatment of Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT03047031
- Acronym / sponsor ID
- 1199-0280
- Conditions
- Idiopathic Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 21 Jul 2022 (actual)
- First posted
- 8 Feb 2017 (estimated)
- Results
- Posted 22 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| All nintedanib treated patients (group B + group C) | – | Drug: Nintedanib |
| Group II- pirfenidone patients | – | Drug: Pirfenidone |
| Group III - pirfenidone patients | – | Drug: Pirfenidone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NintedanibNintedanib | Drug | All nintedanib treated patients (group B + group C) |
| PirfenidonePirfenidone | Drug | Group II- pirfenidone patients, Group III - pirfenidone patients |
Primary outcome
Incidence Rate of All ADRs in Nintedanib Treated Patients
Time frame: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.
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.
Incidence Rate of All SAEs in Nintedanib Treated Patients
Time frame: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.
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.
3 secondary outcomes
Percentage of Patients With AEs Leading to Permanent Dose Reductions of Study Drug
Time frame: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.
Percentage of Patients With AEs Causing Dose Interruption of Study Drug
Time frame: 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
Time frame: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 8 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence Rate of All ADRs in Nintedanib Treated Patients (time frame: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.