Clinical trial NCT05957198: Oxygen Therapy Use in Patients With Fibrotic Interstitial Lung Disease
Official title: Assessment of the Oxygen Use and Future Outcomes Associated With Oxygen Use in Patient With Fibrotic ILD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Diseases, Interstitial
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-07-24
Enrollment: 114921
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients newly diagnosed with fibrosing Interstitial Lung Disease (ILD) during the patient identification period.

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.


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

Primary outcomes:
measure: Time to Oxygen Therapy Initiation
timeFrame: Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)).
measure: Sustained Oxygen Therapy Use Within the First 12 Months of Follow-up
timeFrame: Up to month 12 of follow-up, in patient identification period from 01 October 2016 through 30 June 2022.
measure: Time to Sustained Oxygen Therapy Use
timeFrame: Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)).
measure: Number of Participants With Disease Progression From Pre-index Forced Vital Capacity (FVC) Result to Index Date
timeFrame: Up to 12 months prior to the index date (between 01 October 2016 through 30 June 2022 (patient identification period)).
measure: Number of Participants With Disease Progression From Index Date to Follow-up Forced Vital Capacity (FVC) Result
timeFrame: Up to month 12 of follow-up, in patient identification period from 01 October 2016 through 30 June 2022.
measure: Time to All-cause Mortality
timeFrame: Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)).
Secondary outcomes:
measure: Percentage of Participants With Hypoxemia in the Pre-Interstitial Lung Disease (ILD) Baseline Period
timeFrame: Up to 12 months prior to the fibrosing ILD diagnosis date (between 01 October 2016 through 30 June 2022 (patient identification period)).
measure: Percentage of Participants With Hypoxemia in the Pre-index Baseline Period
timeFrame: Up to 12 months prior to the index date (between 01 October 2016 through 30 June 2022 (patient identification period)).
measure: Percentage of Participants With Acute Exacerbations Within the First 12 Month of the Follow up Period
timeFrame: Up to 12 months post index date (between 01 October 2016 through 30 June 2022 (patient identification period)).
measure: Percentage of Participants With Acute Exacerbations in the Pre-index Baseline Period
timeFrame: Up to 12 months prior to the index date (between 01 October 2016 through 30 June 2022 (patient identification period)).
Other outcomes:
Locations:
city: Ridgefield
country: United States
facility: Boehringer Ingelheim Pharmaceuticals, Inc.
state: Connecticut
Study officials:
References: