Oxygen Therapy Use in Patients With Fibrotic Interstitial Lung Disease

NCT05957198 | Completed Results

• 1 other identifier: 1199-0541
• Study Type: observational
• Target: 114,921
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases, Interstitial

Outcome Measures

Primary Outcomes (6)

• Time to Oxygen Therapy Initiation

  Time from the fibrosing Interstitial Lung Disease (ILD) diagnosis date to oxygen therapy initiation is reported. Descriptive statistics are rounded to one decimal place.

  Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)).

• Sustained Oxygen Therapy Use Within the First 12 Months of Follow-up

  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.

  Up to month 12 of follow-up, in patient identification period from 01 October 2016 through 30 June 2022.

• Time to Sustained Oxygen Therapy Use

  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.

  Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)).

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

  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.

  Up to 12 months prior to the index date (between 01 October 2016 through 30 June 2022 (patient identification period)).

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

  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.

  Up to month 12 of follow-up, in patient identification period from 01 October 2016 through 30 June 2022.

• Time to All-cause Mortality

  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.

  Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)).

Secondary Outcomes (4)

• 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-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 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 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)).

Study Arms (1)

Patients with fibrotic interstitial lung disease (ILD)

Patients aged ≥18 years with ≥2 fibrosing ILD diagnoses and continuous enrollment with medical and pharmacy coverage for 12 months prior to the fibrosing ILD diagnosis date as recorded in a commercial, Medicaid, or Medicare plan, using existing administrative claims and EHR data in Optum's Market Clarity Integrated Claims + Clinical database for the patient identification period (01-Oct-2016 through 30-Jun-2022).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients newly diagnosed with fibrosing Interstitial Lung Disease (ILD) during the patient identification period.

You may qualify if:

• ≥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:
• fibrosis codes
• 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)

You may not qualify if:

• Fibrosing ILD diagnosis in the 12-month pre-ILD baseline period
• Unknown gender, geographic region, or insurance type

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Boehringer Ingelheim Pharmaceuticals, Inc.

Ridgefield, Connecticut, 06877, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

* All ILD patients included in this study were enrolled in a health during the study period; thus, findings from this study may not be applicable to uninsured populations and patients with health plans not represented in the database. * This study minimized bias by utilizing propensity score matching on baseline variables to examine outcomes of interest. Employing matching enabled a comparison of outcomes among patients who were similar on pre-ILD baseline characteristics.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 24, 2023
• Study Start: July 25, 2023
• Primary Completion: September 26, 2023
• Study Completion: September 26, 2023
• Last Updated: November 21, 2024
• Results First Posted: November 21, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)