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Completed

NCT Number: NCT05957198

Oxygen Therapy Use in Patients With Fibrotic Interstitial Lung Disease

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.

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Key information

Conditions

Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Pharmaceuticals, Inc.

Ridgefield, Connecticut, 06877, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Time to Oxygen Therapy Initiation

    Time frame: 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.

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

    Time frame: 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.

  3. Time to Sustained Oxygen Therapy Use

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  6. Time to All-cause Mortality

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 24, 2023
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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