NCT05957198

Oxygen Therapy Use in Patients With Fibrotic Interstitial Lung Disease

Completed Results posted Last updated 21 November 2024

What this trial tests

trial in Lung Diseases, Interstitial in 114,921 participants. Completed in 26 September 2023.

Timeline

25 July 2023

Primary endpoint
26 September 2023

26 September 2023

Quick facts

Lead sponsor	Boehringer Ingelheim
Status	Completed
Study type	OBSERVATIONAL
Enrollment	114,921
Start date	25 July 2023
Primary completion	26 September 2023
Estimated completion	26 September 2023
Sites	1 location across United States

Conditions studied

• Lung Diseases, Interstitial — all drugs for Lung Diseases, Interstitial →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 and older, any sex, with Lung Diseases, Interstitial. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to Oxygen Therapy Initiation Primary · 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.

Group	Value	95% CI
Idiopathic Pulmonary Fibrosis (IPF) Cohort	27.5	25.4 – 29.6
Non Idiopathic Pulmonary Fibrosis (IPF) Cohort	NA	NA – NA

Sustained Oxygen Therapy Use Within the First 12 Months of Follow-up Primary · 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.

Group	Value	95% CI
Idiopathic Pulmonary Fibrosis (IPF) Cohort	967
Non Idiopathic Pulmonary Fibrosis (IPF) Cohort	4973

Time to Sustained Oxygen Therapy Use Primary · 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.

Group	Value	95% CI
Idiopathic Pulmonary Fibrosis (IPF) Cohort	275	184 – 305
Non Idiopathic Pulmonary Fibrosis (IPF) Cohort	266	142 – 305

Number of Participants With Disease Progression From Pre-index Forced Vital Capacity (FVC) Result to Index Date Primary · 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.

Group	Value	95% CI
Oxygen Use Cohort	162
No Oxygen Use Cohort	110

Number of Participants With Disease Progression From Index Date to Follow-up Forced Vital Capacity (FVC) Result Primary · 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.

Group	Value	95% CI
Oxygen Use Cohort	575
No Oxygen Use Cohort	456

Time to All-cause Mortality Primary · 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.

Group	Value	95% CI
Oxygen Use Cohort	53.8	50.8 – 56.5
No Oxygen Use Cohort	NA	NA – NA

Percentage of Participants With Hypoxemia in the Pre-Interstitial Lung Disease (ILD) Baseline Period Secondary · 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.

Group	Value	95% CI
Oxygen Use Cohort	19.9
No Oxygen Use Cohort	14.8

Percentage of Participants With Hypoxemia in the Pre-index Baseline Period Secondary · 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.

Group	Value	95% CI
Oxygen Use Cohort	57.2
No Oxygen Use Cohort	21.0

Percentage of Participants With Acute Exacerbations Within the First 12 Month of the Follow up Period Secondary · 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.

Group	Value	95% CI
Oxygen Use Cohort	3.5
No Oxygen Use Cohort	1.6

Percentage of Participants With Acute Exacerbations in the Pre-index Baseline Period Secondary · 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.

Group	Value	95% CI
Oxygen Use Cohort	2.8
No Oxygen Use Cohort	1.3

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.