Oxygen Therapy Use in Patients With Fibrotic Interstitial Lung Disease

NCT ID: NCT05957198

Last Updated: 2024-11-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

114921 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-25

Study Completion Date

2023-09-26

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Diseases, Interstitial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* ≥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)

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Boehringer Ingelheim Pharmaceuticals, Inc.

Ridgefield, Connecticut, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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1199-0541

Identifier Type: -

Identifier Source: org_study_id

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