Oxygen Therapy Use in Patients With Fibrotic Interstitial Lung Disease

Lung Diseases, Interstitial Clinical Trial

Official title:

Assessment of the Oxygen Use and Future Outcomes Associated With Oxygen Use in Patient With Fibrotic ILD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05957198
• Other study ID #: 1199-0541
• Status: Completed
• Start date: July 25, 2023
• Est. completion date: September 26, 2023

Study information

• Verified date: December 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26212
• Est. completion date: September 26, 2023
• Est. primary completion date: September 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Interstitial

Locations

Country	Name	City	State
United States	Boehringer Ingelheim Pharmaceuticals, Inc.	Ridgefield	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to oxygen therapy initiation	Time in days from the fibrosing Interstitial Lung Disease (ILD) diagnosis date to oxygen therapy initiation.	Up to 5.7 years
Primary	Time to sustained oxygen therapy use	Time in days between the fibrosing ILD diagnosis date and the earliest date that defined the sustained oxygen therapy use.	Up to 5.7 years
Primary	Sustained oxygen therapy use within the first 12 months of follow-up	The number of patients with the evidence of sustained oxygen therapy use during the first 12 months of follow-up.	Up to month 12 of follow-up
Primary	Time to disease progression	Disease progression will be defined as a 10% relative change between the forced vital capacity (FVC) pre-index value and the follow-up value.	Up to 5.7 years
Primary	Time to all-cause mortality	Time to all-cause mortality will be calculated as time between index date and mortality date.	Up to 5.7 years
Secondary	Incidence rate of hypoxemia	Hypoxemia will be defined as oxygen saturation [SpO2] inferior to 90 percent (%).	Up to 5.7 years
Secondary	Incidence rate of respiratory deterioration/acute exacerbations		Up to 5.7 years
Secondary	Number of exacerbations episodes patients experienced		Up to 5.7 years

External Links

•   Related Info