Lung Diseases, InterstitialNCT05875532
Study of Progression to Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Incidence/Management and Treatment
An observational study of Lung Diseases, Interstitial, run by Boehringer Ingelheim at 1 site in United States.
Trial summary
The primary objective for this trial is to investigate the incidence probability of progression to Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) in patients with fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in real-world setting in Japan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Interstitial
- How many people
- 34,960 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2023to 1 May 2023
- 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: Patients diagnosed with at least two fibrosing ILD codes (International Statistical Classification of Diseases and Related Health Problems (ICD-10) code or disease code)
Who may be able to join
- Patients diagnosed with at least two fibrosing Interstitial Lung Disease (ILD) codes on different dates in the patient identification period
- Patients aged 18 years and older on the index date
- Patients for whom data for the 12 months prior to the index date can be extracted as baseline data
Who cannot join
- Patients grouped into the underlying disease of Idiopathic Pulmonary Fibrosis (IPF)
- Patients who have met PF-ILD progression criteria during the baseline period
Trial locations and contacts
1 site in 1 country.
United States1 site
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, Connecticut, 06877
About this study
Official title: Incidence Probability of Progression to Progressive Fibrosing Interstitial Lung Diseases and Status of Management and Treatments in Patients With Fibrosing Interstitial Lung Diseases Other Than Idiopathic Pulmonary Fibrosis in Japan
The primary objective for this trial is to investigate the incidence probability of progression to Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) in patients with fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in real-world setting in Japan.
The secondary objective is to investigate the characteristics of procedures for management and treatment in patients with fibrosing ILD other than IPF in real-world setting in Japan.
- Conditions
- Lung Diseases, Interstitial
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with an ILD other than IPF | Patients in Japan with data available in the Medical Data Vision (MDV) database, presenting an underlying pre-specified Interstitial Lung Disease (ILD) between 01-Jan-2012 to 28-May-2020 and received a second diagnosis of a fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in the period of 01-Jan-2013 to 6 months before 28-May-2020. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Probability of Progression to Pulmonary Fibrosing-Interstitial Lung Disease (PF-ILDs)
The cumulative incidence probability is the estimate of the risk a patient will experience by 6, 12, 18 and 24 months after the second diagnosis of fibrosing ILD (index date) of progression to PF-ILDs. It is the complement of the Kaplan-Meier estimates. The Greenwood's variance estimate was used to calculate the 95% confidence interval.
Disease progression was defined as 3 or more pulmonary function tests within 365 days, 3 or more tomographies within 365 days, 1 or more claims for oxygen therapy during follow-up, 1 or more respiratory hospitalizations during follow-up, 1 or more claims for palliative care during follow-up, 1 or more lung transplant during follow-up, 1 or more claims for immunosuppressive drugs during follow-up, 1 or more claims for oral corticosteroid during follow-up, and 1 or more claims for Nintedanib during follow-up. Follow-up was between 1-Jan-2013 to 28-May-2020, the last encounter in Medical Data Vision database, or in-hospital death, whichever occurs first.
Measured: At 6, 12, 18 and 24 months after the index date, defined between 01-Jan-2013 and 6 months before 28-May-2020
Secondary outcomes (2)
Number of Patients With Treatment of Interest During Follow-up Period
Number of patients treated with immunosuppressive drugs (Rituximab, Tacrolimus, Mycophenolate, Cyclosporine, Cyclophosphamide, Azathioprine, Tocilizumab), oral corticosteroids, or nintedanib during the follow-up period. The follow-up period was between the second diagnosis of a fibrosing ILD (index date) and end of study (28-May-2020), the last encounter in Medical Data Vision database, or in-hospital death, whichever occurs first.
Measured: Up to 7.43 years, from 01-Jan-2013 to 28-May-2020
Number of Patients With Management of Interest During Follow-up Period
Number of patients with oxygen therapy (HOT), lung transplant and palliative care (oxygen inhalation, opioid use) as disease management during the follow-up period. The follow-up period was between the second diagnosis of a fibrosing ILD (index date) and end of study (28-May-2020), the last encounter in Medical Data Vision database, or in-hospital death, whichever occurs first.
Measured: Up to 7.43 years, from 01-Jan-2013 to 28-May-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start20 Apr 2023
- Primary completion1 May 2023
- Study completion1 May 2023
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 Lung Diseases, InterstitialStudies 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
- Retrospective
- Enrolment
- 34,960 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
- NCT05875532
- Sponsor's protocol ID
- 1199-0523
- Status last verified
- Apr 2024
- First submitted
- 30 Apr 2023
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence Probability of Progression to Progressive Fibrosing Interstitial Lung Diseases and Status of Management and Treatments in Patients With Fibrosing Interstitial Lung Diseases Other Than Idiopathic Pulmonary Fibrosis in Japan
- ClinicalTrials.gov ID
- NCT05875532
- Acronym / sponsor ID
- 1199-0523
- Conditions
- Lung Diseases, Interstitial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34,960 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 25 May 2023 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective for this trial is to investigate the incidence probability of progression to Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) in patients with fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in real-world setting in Japan.
The secondary objective is to investigate the characteristics of procedures for management and treatment in patients with fibrosing ILD other than IPF in real-world setting in Japan.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with an ILD other than IPF | – | –Patients in Japan with data available in the Medical Data Vision (MDV) database, presenting an underlying pre-specified Interstitial Lung Disease (ILD) between 01-Jan-2012 to 28-May-2020 and received a second diagnosis of a fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in the period of 01-Jan-2013 to 6 months before 28-May-2020. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with at least two fibrosing ILD codes (International Statistical Classification of Diseases and Related Health Problems (ICD-10) code or disease code)
Key inclusion criteria (3 listed)
- Patients diagnosed with at least two fibrosing Interstitial Lung Disease (ILD) codes on different dates in the patient identification period
- Patients aged 18 years and older on the index date
- Patients for whom data for the 12 months prior to the index date can be extracted as baseline data
Key exclusion criteria (2 listed)
- Patients grouped into the underlying disease of Idiopathic Pulmonary Fibrosis (IPF)
- Patients who have met PF-ILD progression criteria during the baseline period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence Probability of Progression to Pulmonary Fibrosing-Interstitial Lung Disease (PF-ILDs)
Time frame: At 6, 12, 18 and 24 months after the index date, defined between 01-Jan-2013 and 6 months before 28-May-2020
The cumulative incidence probability is the estimate of the risk a patient will experience by 6, 12, 18 and 24 months after the second diagnosis of fibrosing ILD (index date) of progression to PF-ILDs. It is the complement of the Kaplan-Meier estimates. The Greenwood's variance estimate was used to calculate the 95% confidence interval. Disease progression was defined as 3 or more pulmonary function tests within 365 days, 3 or more tomographies within 365 days, 1 or more claims for oxygen therapy during follow-up, 1 or more respiratory hospitalizations during follow-up, 1 or more claims for palliative care during follow-up, 1 or more lung transplant during follow-up, 1 or more claims for immunosuppressive drugs during follow-up, 1 or more claims for oral corticosteroid during follow-up, and 1 or more claims for Nintedanib during follow-up. Follow-up was between 1-Jan-2013 to 28-May-2020, the last encounter in Medical Data Vision database, or in-hospital death, whichever occurs first.
2 secondary outcomes
Number of Patients With Treatment of Interest During Follow-up Period
Time frame: Up to 7.43 years, from 01-Jan-2013 to 28-May-2020
Number of Patients With Management of Interest During Follow-up Period
Time frame: Up to 7.43 years, from 01-Jan-2013 to 28-May-2020
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, Interstitial, run by Boehringer Ingelheim at 1 site in United States.
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 3 inclusion and 2 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 19 Sep 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 Probability of Progression to Pulmonary Fibrosing-Interstitial Lung Disease (PF-ILDs) (time frame: At 6, 12, 18 and 24 months after the index date, defined between 01-Jan-2013 and 6 months before 28-May-2020). 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 19 Sep 2024.