Oxygen Therapy Use in Patients With Fibrotic Interstitial Lung Disease
- Conditions
- Lung Diseases, Interstitial
- Registration Number
- NCT05957198
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114921
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to Oxygen Therapy Initiation Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)). Time from the fibrosing Interstitial Lung Disease (ILD) diagnosis date to oxygen therapy initiation is reported.
Descriptive statistics are rounded to one decimal place.Sustained Oxygen Therapy Use Within the First 12 Months of Follow-up Up to month 12 of follow-up, in patient identification period from 01 October 2016 through 30 June 2022. The number of participants with ≥ 11 claims for oxygen therapy within 12 months of initiating oxygen therapy is reported.
Using claims, sustained oxygen therapy use was defined among patients with at least 12 months of follow-up after the index date (oxygen initiation date), as a binary variable for the presence of ≥11 claims for oxygen therapy in a 12-month period.Time to Sustained Oxygen Therapy Use Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)). Time between the fibrosing ILD diagnosis date and the earliest date that defined the sustained oxygen therapy use is reported.
Sustained oxygen therapy was defined as ≥ 11 claims for oxygen therapy within 12 months of initiating oxygen therapy.Number of Participants With Disease Progression From Pre-index Forced Vital Capacity (FVC) Result to Index Date Up to 12 months prior to the index date (between 01 October 2016 through 30 June 2022 (patient identification period)). The Number of participants with disease progression is reported instead of time to disease progression in the Outcome Measure Data Table.
Disease progression was defined as a 10% relative change between the forced vital capacity (FVC) pre-index value and the index date.Number of Participants With Disease Progression From Index Date to Follow-up Forced Vital Capacity (FVC) Result Up to month 12 of follow-up, in patient identification period from 01 October 2016 through 30 June 2022. The Number of participants with disease progression is reported instead of time to disease progression in the Outcome Measure Data Table.
Disease progression was defined as a 10% relative change between the index date to follow-up FVC result.Time to All-cause Mortality Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)). Time to all-cause mortality is calculated as time between index date and mortality date.
The oxygen therapy cohort index date was defined as the first date of a claim for oxygen therapy.
The no oxygen therapy cohort index date was assigned as a date that was eligible to set an index date.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Hypoxemia in the Pre-Interstitial Lung Disease (ILD) Baseline Period Up to 12 months prior to the fibrosing ILD diagnosis date (between 01 October 2016 through 30 June 2022 (patient identification period)). Percentage of participants with hypoxemia in the pre-ILD baseline period. The Percentage of participants is reported instead of time to hypoxemia in the Outcome Measure Data Table.
The pre-ILD baseline period is defined as 12 months prior to the fibrosing ILD diagnosis date.Percentage of Participants With Hypoxemia in the Pre-index Baseline Period Up to 12 months prior to the index date (between 01 October 2016 through 30 June 2022 (patient identification period)). Percentage of participants with hypoxemia in the pre-index baseline period. The Percentage of participants is reported instead of time to hypoxemia in the Outcome Measure Data Table.
The pre-index period was defined as the 12-month period prior to the index date. The index date is the first day of follow-up observation time for Aim 2.Percentage of Participants With Acute Exacerbations Within the First 12 Month of the Follow up Period Up to 12 months post index date (between 01 October 2016 through 30 June 2022 (patient identification period)). Percentage of participants with acute exacerbations within the first 12 month of the follow up period. The Percentage of participants is reported instead of time to acute exacerbations in the Outcome Measure Data Table.
The follow up period (variable period) started on the index date until the earliest of the following: disenrollment from the health plan, death, or the end of the study period.Percentage of Participants With Acute Exacerbations in the Pre-index Baseline Period Up to 12 months prior to the index date (between 01 October 2016 through 30 June 2022 (patient identification period)). Percentage of participants with acute exacerbations in the pre-index baseline period. The Percentage of participants is reported instead of time to acute exacerbations in the Outcome Measure Data Table.
The pre-index period was defined as the 12-month period prior to the index date. The index date is the first day of follow-up observation time for Aim 2.
Trial Locations
- Locations (1)
Boehringer Ingelheim Pharmaceuticals, Inc.
🇺🇸Ridgefield, Connecticut, United States