Oxygen Therapy Use in Patients With Fibrotic Interstitial Lung Disease

Study Overview
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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.

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

Conditions
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Lung Diseases, Interstitial

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ILD patients<br>Health claims and Electronic Health Records of patients diagnosed with Interstitial Lung Disease (ILD) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to oxygen therapy initiation | Time in days from the fibrosing Interstitial Lung Disease (ILD) diagnosis date to oxygen therapy initiation. | Up to 5.7 years | 
| Time to sustained oxygen therapy use | Time in days between the fibrosing ILD diagnosis date and the earliest date that defined the sustained oxygen therapy use. | Up to 5.7 years | 
| Sustained oxygen therapy use within the first 12 months of follow-up | The number of patients with the evidence of sustained oxygen therapy use during the first 12 months of follow-up. | Up to month 12 of follow-up | 
| Time to disease progression | Disease progression will be defined as a 10% relative change between the forced vital capacity (FVC) pre-index value and the follow-up value. | Up to 5.7 years | 
| Time to all-cause mortality | Time to all-cause mortality will be calculated as time between index date and mortality date. | Up to 5.7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of hypoxemia | Hypoxemia will be defined as oxygen saturation [SpO2] inferior to 90 percent (%). | Up to 5.7 years | 
| Incidence rate of respiratory deterioration/acute exacerbations |  | Up to 5.7 years | 
| Number of exacerbations episodes patients experienced |  | Up to 5.7 years |