Oxygen Therapy Use in Patients With Fibrotic Interstitial Lung Disease
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ILD patients Health claims and Electronic Health Records of patients diagnosed with Interstitial Lung Disease (ILD) |
Outcome Measures
Primary Outcome Measures
- Time to oxygen therapy initiation [Up to 5.7 years]
Time in days from the fibrosing Interstitial Lung Disease (ILD) diagnosis date to oxygen therapy initiation.
- Time to sustained oxygen therapy use [Up to 5.7 years]
Time in days between the fibrosing ILD diagnosis date and the earliest date that defined the sustained oxygen therapy use.
- Sustained oxygen therapy use within the first 12 months of follow-up [Up to month 12 of follow-up]
The number of patients with the evidence of sustained oxygen therapy use during the first 12 months of follow-up.
- Time to disease progression [Up to 5.7 years]
Disease progression will be defined as a 10% relative change between the forced vital capacity (FVC) pre-index value and the follow-up value.
- Time to all-cause mortality [Up to 5.7 years]
Time to all-cause mortality will be calculated as time between index date and mortality date.
Secondary Outcome Measures
- Incidence rate of hypoxemia [Up to 5.7 years]
Hypoxemia will be defined as oxygen saturation [SpO2] inferior to 90 percent (%).
- Incidence rate of respiratory deterioration/acute exacerbations [Up to 5.7 years]
- Number of exacerbations episodes patients experienced [Up to 5.7 years]
Eligibility Criteria
Criteria
Inclusion criteria:
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≥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:
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2 fibrosis codes
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1 fibrosis code & 1 ILD code that requires fibrosis code
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≥18 years of age as of the fibrosing ILD diagnosis date
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Continuous enrollment with medical and pharmacy coverage for 12 months prior to the fibrosing ILD diagnosis date (pre-ILD baseline period)
Exclusion criteria:
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Fibrosing ILD diagnosis in the 12-month pre-ILD baseline period
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Unknown gender, geographic region, or insurance type
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boehringer Ingelheim Pharmaceuticals, Inc. | Ridgefield | Connecticut | United States | 06877 |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1199-0541