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临床试验/NCT05957198
NCT05957198已完成不适用

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

Boehringer Ingelheim1 个研究点 分布在 1 个国家目标入组 114,921 人开始时间: 2023年7月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
114,921
试验地点
1
主要终点
Time to Oxygen Therapy Initiation

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Time to Oxygen Therapy Initiation

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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)).)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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