Lung Diseases, InterstitialNCT05957198

Oxygen Therapy Use in Patients With Fibrotic Interstitial Lung Disease

An observational study of Lung Diseases, Interstitial, run by Boehringer Ingelheim at 1 site in United States.

Completed

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

Trial summary

The purpose of this study is to describe initiation and use of oxygen therapy among patients with fibrotic Interstitial Lung Disease (ILD) and to assess the impact of oxygen therapy on clinical outcomes among patients with fibrotic ILD. 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: 114,921 participants
Where: 1 siteUnited States
Study dates: 25 Jul 2023to 26 Sep 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 newly diagnosed with fibrosing Interstitial Lung Disease (ILD) during the patient identification period.

Who may be able to join

≥2 fibrosing Interstitial Lung Disease (ILD) diagnoses in any position on different dates of service, within 365 days of each other, and in the same continuous enrollment period during the patient identification period. The fibrosing ILD diagnosis date will be defined as the date of the first fibrosing ILD diagnosis. The two fibrosing ILD diagnosis codes can be one of the following combinations:
2 fibrosis codes
1 fibrosis code \& 1 ILD code that requires fibrosis code
≥18 years of age as of the fibrosing ILD diagnosis date
Continuous enrollment with medical and pharmacy coverage for 12 months prior to the fibrosing ILD diagnosis date (pre-ILD baseline period)

Who cannot join

Fibrosing ILD diagnosis in the 12-month pre-ILD baseline period
Unknown gender, geographic region, or insurance type

Trial locations and contacts

1 site in 1 country.

United States1 site

Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, Connecticut, 06877

Other trials in United States

About this study

Official title: Assessment of the Oxygen Use and Future Outcomes Associated With Oxygen Use in Patient With Fibrotic ILD

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 groups in NCT05957198
Study group	Role	What they receive
Patients with fibrotic interstitial lung disease (ILD)		Patients aged ≥18 years with ≥2 fibrosing ILD diagnoses and continuous enrollment with medical and pharmacy coverage for 12 months prior to the fibrosing ILD diagnosis date as recorded in a commercial, Medicaid, or Medicare plan, using existing administrative claims and EHR data in Optum's Market Clarity Integrated Claims + Clinical database for the patient identification period (01-Oct-2016 through 30-Jun-2022).

What is being measured

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

Time to Oxygen Therapy Initiation
Time from the fibrosing Interstitial Lung Disease (ILD) diagnosis date to oxygen therapy initiation is reported.
Descriptive statistics are rounded to one decimal place.
Measured: Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)).
Sustained Oxygen Therapy Use Within the First 12 Months of Follow-up
The number of participants with ≥ 11 claims for oxygen therapy within 12 months of initiating oxygen therapy is reported.
Using claims, sustained oxygen therapy use was defined among patients with at least 12 months of follow-up after the index date (oxygen initiation date), as a binary variable for the presence of ≥11 claims for oxygen therapy in a 12-month period.
Measured: Up to month 12 of follow-up, in patient identification period from 01 October 2016 through 30 June 2022.
Time to Sustained Oxygen Therapy Use
Time between the fibrosing ILD diagnosis date and the earliest date that defined the sustained oxygen therapy use is reported.
Sustained oxygen therapy was defined as ≥ 11 claims for oxygen therapy within 12 months of initiating oxygen therapy.
Measured: Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)).
Number of Participants With Disease Progression From Pre-index Forced Vital Capacity (FVC) Result to Index Date
The Number of participants with disease progression is reported instead of time to disease progression in the Outcome Measure Data Table.
Disease progression was defined as a 10% relative change between the forced vital capacity (FVC) pre-index value and the index date.
Measured: Up to 12 months prior to the index date (between 01 October 2016 through 30 June 2022 (patient identification period)).
Number of Participants With Disease Progression From Index Date to Follow-up Forced Vital Capacity (FVC) Result
The Number of participants with disease progression is reported instead of time to disease progression in the Outcome Measure Data Table.
Disease progression was defined as a 10% relative change between the index date to follow-up FVC result.
Measured: Up to month 12 of follow-up, in patient identification period from 01 October 2016 through 30 June 2022.
Time to All-cause Mortality
Time to all-cause mortality is calculated as time between index date and mortality date.
The oxygen therapy cohort index date was defined as the first date of a claim for oxygen therapy.
The no oxygen therapy cohort index date was assigned as a date that was eligible to set an index date.
Measured: Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)).

Secondary outcomes (4)

Percentage of Participants With Hypoxemia in the Pre-Interstitial Lung Disease (ILD) Baseline Period
Percentage of participants with hypoxemia in the pre-ILD baseline period. The Percentage of participants is reported instead of time to hypoxemia in the Outcome Measure Data Table.
The pre-ILD baseline period is defined as 12 months prior to the fibrosing ILD diagnosis date.
Measured: Up to 12 months prior to the fibrosing ILD diagnosis date (between 01 October 2016 through 30 June 2022 (patient identification period)).
Percentage of Participants With Hypoxemia in the Pre-index Baseline Period
Percentage of participants with hypoxemia in the pre-index baseline period. The Percentage of participants is reported instead of time to hypoxemia in the Outcome Measure Data Table.
The pre-index period was defined as the 12-month period prior to the index date. The index date is the first day of follow-up observation time for Aim 2.
Measured: Up to 12 months prior to the index date (between 01 October 2016 through 30 June 2022 (patient identification period)).
Percentage of Participants With Acute Exacerbations Within the First 12 Month of the Follow up Period
Percentage of participants with acute exacerbations within the first 12 month of the follow up period. The Percentage of participants is reported instead of time to acute exacerbations in the Outcome Measure Data Table.
The follow up period (variable period) started on the index date until the earliest of the following: disenrollment from the health plan, death, or the end of the study period.
Measured: Up to 12 months post index date (between 01 October 2016 through 30 June 2022 (patient identification period)).
Percentage of Participants With Acute Exacerbations in the Pre-index Baseline Period
Percentage of participants with acute exacerbations in the pre-index baseline period. The Percentage of participants is reported instead of time to acute exacerbations in the Outcome Measure Data Table.
The pre-index period was defined as the 12-month period prior to the index date. The index date is the first day of follow-up observation time for Aim 2.
Measured: Up to 12 months prior to the index date (between 01 October 2016 through 30 June 2022 (patient identification period)).

Timeline

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

25 Jul 202326 Sep 2023

First posted24 Jul 2023
Study start25 Jul 2023
Primary completion26 Sep 2023
Study completion26 Sep 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: 114,921 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05957198
Sponsor's protocol ID: 1199-0541
Status last verified: Sep 2024
First submitted: 14 Jul 2023
Last updated: 21 Nov 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

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
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Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
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RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
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RecruitingObservational study
Single-Cell Sequencing Analysis of Radiation Pneumonitis Signals In Patients Treated For Cancer With Radiotherapy
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RecruitingPhase 2
Ambulatory Oxygen Therapy for Individuals With Mild-to-moderate Interstitial Lung Disease
Fibrotic Interstitial Lung Disease

All Lung Diseases, Interstitial trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of the Oxygen Use and Future Outcomes Associated With Oxygen Use in Patient With Fibrotic ILD
ClinicalTrials.gov ID: NCT05957198
Acronym / sponsor ID: 1199-0541
Conditions: Lung Diseases, Interstitial
Study type: Observational
Recruitment status: Completed
Enrolment: 114,921 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 25 Jul 2023 (actual)
Primary completion: 26 Sep 2023 (actual)
Study completion: 26 Sep 2023 (actual)
First posted: 24 Jul 2023 (actual)
Results: Posted 21 Nov 2024

Clinical summary

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

Study design

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

Arm	Type	Receives
Patients with fibrotic interstitial lung disease (ILD)	–	–Patients aged ≥18 years with ≥2 fibrosing ILD diagnoses and continuous enrollment with medical and pharmacy coverage for 12 months prior to the fibrosing ILD diagnosis date as recorded in a commercial, Medicaid, or Medicare plan, using existing administrative claims and EHR data in Optum's Market Clarity Integrated Claims + Clinical database for the patient identification period (01-Oct-2016 through 30-Jun-2022).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients newly diagnosed with fibrosing Interstitial Lung Disease (ILD) during the patient identification period.

Key inclusion criteria (5 listed)

≥2 fibrosing Interstitial Lung Disease (ILD) diagnoses in any position on different dates of service, within 365 days of each other, and in the same continuous enrollment period during the patient identification period. The fibrosing ILD diagnosis date will be defined as the date of the first fibrosing ILD diagnosis. The two fibrosing ILD diagnosis codes can be one of the following combinations:
2 fibrosis codes
1 fibrosis code \& 1 ILD code that requires fibrosis code
≥18 years of age as of the fibrosing ILD diagnosis date
Continuous enrollment with medical and pharmacy coverage for 12 months prior to the fibrosing ILD diagnosis date (pre-ILD baseline period)

Key exclusion criteria (2 listed)

Fibrosing ILD diagnosis in the 12-month pre-ILD baseline period
Unknown gender, geographic region, or insurance type

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

Time to Oxygen Therapy Initiation
Time frame: Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)).
Time from the fibrosing Interstitial Lung Disease (ILD) diagnosis date to oxygen therapy initiation is reported. Descriptive statistics are rounded to one decimal place.
Sustained Oxygen Therapy Use Within the First 12 Months of Follow-up
Time frame: Up to month 12 of follow-up, in patient identification period from 01 October 2016 through 30 June 2022.
The number of participants with ≥ 11 claims for oxygen therapy within 12 months of initiating oxygen therapy is reported. Using claims, sustained oxygen therapy use was defined among patients with at least 12 months of follow-up after the index date (oxygen initiation date), as a binary variable for the presence of ≥11 claims for oxygen therapy in a 12-month period.
Time to Sustained Oxygen Therapy Use
Time frame: Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)).
Time between the fibrosing ILD diagnosis date and the earliest date that defined the sustained oxygen therapy use is reported. Sustained oxygen therapy was defined as ≥ 11 claims for oxygen therapy within 12 months of initiating oxygen therapy.
Number of Participants With Disease Progression From Pre-index Forced Vital Capacity (FVC) Result to Index Date
Time frame: Up to 12 months prior to the index date (between 01 October 2016 through 30 June 2022 (patient identification period)).
The Number of participants with disease progression is reported instead of time to disease progression in the Outcome Measure Data Table. Disease progression was defined as a 10% relative change between the forced vital capacity (FVC) pre-index value and the index date.
Number of Participants With Disease Progression From Index Date to Follow-up Forced Vital Capacity (FVC) Result
Time frame: Up to month 12 of follow-up, in patient identification period from 01 October 2016 through 30 June 2022.
The Number of participants with disease progression is reported instead of time to disease progression in the Outcome Measure Data Table. Disease progression was defined as a 10% relative change between the index date to follow-up FVC result.
Time to All-cause Mortality
Time frame: Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)).
Time to all-cause mortality is calculated as time between index date and mortality date. The oxygen therapy cohort index date was defined as the first date of a claim for oxygen therapy. The no oxygen therapy cohort index date was assigned as a date that was eligible to set an index date.

4 secondary outcomes

Percentage of Participants With Hypoxemia in the Pre-Interstitial Lung Disease (ILD) Baseline Period
Time frame: Up to 12 months prior to the fibrosing ILD diagnosis date (between 01 October 2016 through 30 June 2022 (patient identification period)).
Percentage of Participants With Hypoxemia in the Pre-index Baseline Period
Time frame: Up to 12 months prior to the index date (between 01 October 2016 through 30 June 2022 (patient identification period)).
Percentage of Participants With Acute Exacerbations Within the First 12 Month of the Follow up Period
Time frame: Up to 12 months post index date (between 01 October 2016 through 30 June 2022 (patient identification period)).
Percentage of Participants With Acute Exacerbations in the Pre-index Baseline Period
Time frame: Up to 12 months prior to the index date (between 01 October 2016 through 30 June 2022 (patient identification period)).

Results and safety

Results posted to the registry on 21 Nov 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
Patients With Fibrotic Interstitial Lung Disease (ILD)	114,921	114,921

Primary outcome: Time to Oxygen Therapy Initiation

Time frame: Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)).. Median (Inter-Quartile Range). Unit: Months

Measure	Idiopathic Pulmonary Fibrosis (IPF) Cohort n = 4779	Non Idiopathic Pulmonary Fibrosis (IPF) Cohort n = 88799
Value	27.5 (25.4 to 29.6)	NA (NA to NA)

Primary outcome: Sustained Oxygen Therapy Use Within the First 12 Months of Follow-up

Time frame: Up to month 12 of follow-up, in patient identification period from 01 October 2016 through 30 June 2022.. Count of participants. Unit: Participants

Measure	Idiopathic Pulmonary Fibrosis (IPF) Cohort n = 1339	Non Idiopathic Pulmonary Fibrosis (IPF) Cohort n = 10592
Value	967	4973

Population analysed: Population AIM 1 include patients newly diagnosed with fibrosing ILD during the patient identification period and met all the eligibility criteria. Population AIM 1 in this endpoint restricted to patients with sustained oxygen therapy use within 12 months of initiating oxygen therapy patients and with ≥ 11 claims for oxygen therapy within 12 months of initiating oxygen therapy.

Primary outcome: Time to Sustained Oxygen Therapy Use

Time frame: Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)).. Median (Inter-Quartile Range). Unit: Days

Measure	Idiopathic Pulmonary Fibrosis (IPF) Cohort n = 967	Non Idiopathic Pulmonary Fibrosis (IPF) Cohort n = 4973
Value	275 (184 to 305)	266 (142 to 305)

Primary outcome: Number of Participants With Disease Progression From Pre-index Forced Vital Capacity (FVC) Result to Index Date

Time frame: Up to 12 months prior to the index date (between 01 October 2016 through 30 June 2022 (patient identification period)).. Count of participants. Unit: Participants

Measure	Oxygen Use Cohort n = 24680	No Oxygen Use Cohort n = 24680
Value	162	110

Population analysed: Among the 24,686 fibrosing Interstitial Lung Disease (ILD) patients who initiated oxygen therapy during the Aim 1 follow-up period, 24,680 were successfully matched at a 1:1 ratio with a fibrosing ILD patient who did not yet initiate oxygen therapy. Patients of the matched cohort are included for which pre-index and follow-up forced vital capacity (FVC) results were available.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Not applicable for other Adverse Events (AEs) and serious AEs. All-Cause mortality was recorded between 01 October 2016 and 30 June 2022, up to 2099 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With Fibrotic Interstitial Lung Disease (ILD)	0 of 0	0 of 0	21,503 of 114,921

Limitations and caveats (from the sponsor): * All ILD patients included in this study were enrolled in a health during the study period; thus, findings from this study may not be applicable to uninsured populations and patients with health plans not represented in the database. * This study minimized bias by utilizing propensity score matching on baseline variables to examine outcomes of interest. Employing matching enabled a comparison of outcomes among patients who were similar on pre-ILD baseline characteristics.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 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

Related trials for Lung Diseases, Interstitial

RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
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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 5 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 21 Nov 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 21 Nov 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?

Time to Oxygen Therapy Initiation (time frame: Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)).). The study lists 6 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 NCT05957198.

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 21 Nov 2024.