N/A
N=114,921
Oxygen Therapy Use in Patients With Fibrotic Interstitial Lung Disease
Lung Diseases, Interstitial
Bottom Line
View on ClinicalTrials.gov: NCT05957198 ↗Enrolled (actual)
114,921
Serious AEs
—
Results posted
Nov 2024
Primary outcome: Primary: Time to Oxygen Therapy Initiation — 27.5; NA Months
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Oxygen Therapy Initiation |
27.5; NA | — |
| PRIMARY Sustained Oxygen Therapy Use Within the First 12 Months of Follow-up |
967; 4973 | — |
| PRIMARY Time to Sustained Oxygen Therapy Use |
275; 266 | — |
| PRIMARY Number of Participants With Disease Progression From Pre-index Forced Vital Capacity (FVC) Result to Index Date |
162; 110 | — |
| PRIMARY Number of Participants With Disease Progression From Index Date to Follow-up Forced Vital Capacity (FVC) Result |
575; 456 | — |
| PRIMARY Time to All-cause Mortality |
53.8; NA | — |
| SECONDARY Percentage of Participants With Hypoxemia in the Pre-Interstitial Lung Disease (ILD) Baseline Period |
19.9; 14.8 | — |
| SECONDARY Percentage of Participants With Hypoxemia in the Pre-index Baseline Period |
57.2; 21.0 | — |
| SECONDARY Percentage of Participants With Acute Exacerbations Within the First 12 Month of the Follow up Period |
3.5; 1.6 | — |
| SECONDARY Percentage of Participants With Acute Exacerbations in the Pre-index Baseline Period |
2.8; 1.3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05957198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.