Idiopathic Pulmonary FibrosisNCT04525547

Safety and Effectiveness of Nintedanib in Korean Patients

An observational study of Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 22 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objectives of this study are to monitor the safety and effectiveness of Ofev in Korean patients in a routine clinical practice setting. Read more about this study

Who is it for?: Any age
Conditions the study is for: Idiopathic Pulmonary Fibrosis
What is being tested?: Nintedanib
How many people: 70 participants
Where: 22 sitesSouth Korea
Study dates: 13 Jan 2021to 18 Aug 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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: * Patients diagnosed with idiopathic pulmonary fibrosis * (or) Patients diagnosed with systemic sclerosis associated interstitial lung disease * (or) patients diagnosed with chronic fibrosing ILD with a progressive phenotype

Who may be able to join

Patients who have been started on Ofev in accordance with the approved label in Korea
Patients who have signed on the data release consent form

Who cannot join

Patients for whom nintedanib is contraindicated according local label of Ofev
Patients with known hypersensitivity to Ofev, peanut or soya, or to any of the excipients
Women who are pregnant or nursing
Patients with moderate(Child pugh B) and severe(Child Pugh c) hepatic impairment

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

South Korea22 sites

Dong-A University Hospital
Busan, 49201
Chungbuk national University Hospital
Chungcheongbuk-do, 28644
SoonChunHyang University Cheonan Hospital
Chungcheongnam-do, 31151
Keimyung University Dongsan Hospital
Daegu, 42601
Chonnam National University Hospital
Gwangju, 61469
Inje University Ilsan Paik Hospital
Gyeonggi-do, 10380
Seoul National University Bundang Hospital
Gyeonggi-do, 13620
Myongji Hospital
Gyeonggi-do, 67924
Pusan National University Yangsan Hospital
Gyeongsangnam-do, 50612
Gyeongsang National University Changwon Hospital
Gyeongsangnam-do, 51472
Jeju National University Hospital
Jeju-do, 63241
Wonkwang Univertisy Hospital
Jeollabuk-do, 54538
Jeonbuk National University Hospital
Jeollabuk-do, 54907
KyungHee University Medical Center
Seoul, 02447
Seoul National University Hospital
Seoul, 03080
Severance Hospital
Seoul, 03722
Hanyang University Medical Center
Seoul, 04763
Kyung Hee University Hospital at Gangdong
Seoul, 05278
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Catholic University of Korea Seoul St. Mary's Hospital
Seoul, 06591
Ulsan University Hospital
Ulsan, 44033

Other trials in South Korea

About this study

Official title: A Regulatory Required Non-interventional Study to Monitor the Safety and Effectiveness of Ofev(Nintedanib 150mg/100mg BID) in Korean Patients

The objectives of this study are to monitor the safety and effectiveness of Ofev in Korean patients in a routine clinical practice setting.

Conditions: Idiopathic Pulmonary Fibrosis
Being tested: Nintedanib
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
Also called Ofev
Nintedanib

Study groups in NCT04525547
Study group	Role	What they receive
Ofev treatment		Korean patients diagnosed with idiopathic pulmonary fibrosis, systemic sclerosis associated interstitial lung disease or chronic fibrosing interstitial lung diseases with a progressive phenotype receiving Ofev (nintedanib 150milligrams (mg)/100mg twice a day (BID)) Receives: Drug: Nintedanib

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With Adverse Events Who Took at Least One Dose of Ofev
Number of patients with adverse events who took at least one dose of Ofev is presented.
Measured: Up to 24 weeks.
Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 12 Weeks of Treatment
Change from baseline in Forced Vital Capacity) (FVC) (mL) after 12 weeks of treatment is presented.
Forced vital capacity (FVC) is part of a pulmonary function test that assesses the lung function. It is defined as the greatest volume of air that can be expelled when a person performs a rapid, forced exhalation.
Measured: At baseline and at week 12.
Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 24 Weeks of Treatment
Change from baseline in Forced Vital Capacity) (FVC) (mL) after 24 weeks of treatment is presented.
Forced vital capacity (FVC) is part of a pulmonary function test that assesses the lung function. It is defined as the greatest volume of air that can be expelled when a person performs a rapid, forced exhalation.
Measured: At baseline and at week 24.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jan 202118 Aug 2022

First posted25 Aug 2020
Study start13 Jan 2021
Primary completion2 Aug 2022
Study completion18 Aug 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: Prospective
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04525547
Sponsor's protocol ID: 1199-0417
Status last verified: Aug 2023
First submitted: 21 Aug 2020
Last updated: 12 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)

All Idiopathic Pulmonary Fibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Regulatory Required Non-interventional Study to Monitor the Safety and Effectiveness of Ofev(Nintedanib 150mg/100mg BID) in Korean Patients
ClinicalTrials.gov ID: NCT04525547
Acronym / sponsor ID: 1199-0417
Conditions: Idiopathic Pulmonary Fibrosis
Study type: Observational
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 13 Jan 2021 (actual)
Primary completion: 2 Aug 2022 (actual)
Study completion: 18 Aug 2022 (actual)
First posted: 25 Aug 2020 (actual)
Results: Posted 12 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objectives of this study are to monitor the safety and effectiveness of Ofev in Korean patients in a routine clinical practice setting.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Ofev treatment	–	Drug: NintedanibKorean patients diagnosed with idiopathic pulmonary fibrosis, systemic sclerosis associated interstitial lung disease or chronic fibrosing interstitial lung diseases with a progressive phenotype receiving Ofev (nintedanib 150milligrams (mg)/100mg twice a day (BID))

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: * Patients diagnosed with idiopathic pulmonary fibrosis * (or) Patients diagnosed with systemic sclerosis associated interstitial lung disease * (or) patients diagnosed with chronic fibrosing ILD with a progressive phenotype

Key inclusion criteria (2 listed)

Patients who have been started on Ofev in accordance with the approved label in Korea
Patients who have signed on the data release consent form

Key exclusion criteria (4 listed)

Patients for whom nintedanib is contraindicated according local label of Ofev

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
NintedanibAlso: OfevNintedanib	Drug	Ofev treatment

Primary outcome

Number of Patients With Adverse Events Who Took at Least One Dose of Ofev
Time frame: Up to 24 weeks.
Number of patients with adverse events who took at least one dose of Ofev is presented.
Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 12 Weeks of Treatment
Time frame: At baseline and at week 12.
Change from baseline in Forced Vital Capacity) (FVC) (mL) after 12 weeks of treatment is presented. Forced vital capacity (FVC) is part of a pulmonary function test that assesses the lung function. It is defined as the greatest volume of air that can be expelled when a person performs a rapid, forced exhalation.
Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 24 Weeks of Treatment
Time frame: At baseline and at week 24.
Change from baseline in Forced Vital Capacity) (FVC) (mL) after 24 weeks of treatment is presented. Forced vital capacity (FVC) is part of a pulmonary function test that assesses the lung function. It is defined as the greatest volume of air that can be expelled when a person performs a rapid, forced exhalation.

Results and safety

Results posted to the registry on 12 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ofev Treatment	70	65

Primary outcome: Number of Patients With Adverse Events Who Took at Least One Dose of Ofev

Time frame: Up to 24 weeks.. Count of participants. Unit: Participants

Measure	Ofev Treatment n = 65
Value	36

Population analysed: The safety set included all subjects who signed the data release consent form to participate in this study, took Ofev once at least, and were followed up by the physician once or more.

Primary outcome: Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 12 Weeks of Treatment

Time frame: At baseline and at week 12.. Mean (Standard Deviation). Unit: MilliLitres (mL)

Measure	Ofev Treatment n = 18
Value	-15.00 (270.73)

Ofev Treatment: p = 0.8170, t-test, 2 sided

Population analysed: The effectiveness set included safety set who were evaluated for the effectiveness including overall effectiveness evaluation. Only participants with non-missing results were included in the analysis.

Primary outcome: Change From Baseline in Forced Vital Capacity) (FVC) (mL) After 24 Weeks of Treatment

Time frame: At baseline and at week 24.. Mean (Standard Deviation). Unit: MilliLitres (mL)

Measure	Ofev Treatment n = 10
Value	-44.00 (299.49)

Ofev Treatment: p = 0.6533, t-test, 2 sided

Adverse events

Time frame: Up to 24 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ofev Treatment	16 of 65 (24.6%)	17 of 65 (26.2%)	3 of 65

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

Related trials for Idiopathic Pulmonary Fibrosis

RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)

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.

22 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 22 sites in South Korea.

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 2 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 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in South Korea. 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 12 Mar 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?

Number of Patients With Adverse Events Who Took at Least One Dose of Ofev (time frame: Up to 24 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04525547.

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 12 Mar 2024.