Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hypoxemia in the Pre-Interstitial Lung Disease (ILD) Baseline 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. | Up to 12 months prior to the fibrosing ILD diagnosis date (between 01 October 2016 through 30 June 2022 (patient identification period)). |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Patients newly diagnosed with fibrosing Interstitial Lung Disease (ILD) during the patient identification period.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Pharmaceuticals, Inc. | Ridgefield | Connecticut | 06877 | United States |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
Not provided
Not provided
Not provided
Not provided
All subjects were screened for eligibility prior to participation in the trial.
This was a non-interventional study in patients with Fibrotic Interstitial Lung Disease (ILD) enrolled in a commercial, Medicaid, or Medicare plan, using existing administrative claims and Electronic Health Record (EHR) data in Optum's Market Clarity Integrated Claims + Clinical database for the period of 01 October 2015 through 30 June 2022 (study period). The patient identification period was (01-Oct-2016 through 30-Jun-2022).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients aged ≥18 years with newly diagnosed fibrosing ILD were identified from 01 October 2016 through 30 June 2022 (patient identification period) in existing data from a commercial, Medicaid, or Medicare plan, using existing administrative claims and electronic health record (EHR) data in Optum's Market Clarity Integrated Claims + Clinical database.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Population AIM 1 include patients newly diagnosed with fibrosing ILD during the patient identification period and met all the eligibility criteria. Population AIM 1 in this endpoint restricted to patients without baseline oxygen therapy use. | Posted | Median | Inter-Quartile Range | Months | Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)). |
|
Not applicable for other Adverse Events (AEs) and serious AEs. All-Cause mortality was recorded between 01 October 2016 and 30 June 2022, up to 2099 days.
This is a study with secondary use of data, safety reporting on an individual case level is not applicable. Other Adverse Events (AEs) and Serious AEs were not collected. "0" total Number of Participants at Risk means not collected.
All-cause mortality is reported on AIM 1 population because AIM 2 does not include all subjects and deaths. AIM 1 is larger but it is not divided by oxygen use.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2023 | Sep 4, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
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)). |
| Percentage of Participants With Hypoxemia in the Pre-index Baseline 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. | 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 | 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. | 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 | 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. | Up to 12 months prior to the index date (between 01 October 2016 through 30 June 2022 (patient identification period)). |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Non Idiopathic Pulmonary Fibrosis (IPF) Cohort | Patients aged ≥ 18 years with newly diagnosed fibrosing interstitial lung disease (ILD) during the patient identification period with ≥2 fibrosing ILD diagnoses, continuous enrollment with medical and pharmacy coverage for 12 months prior to the fibrosing ILD diagnosis date (pre-ILD baseline period) and no claims with diagnosis for idiopathic pulmonary fibrosis (IPF) in any position during the study period. |
|
|
| Primary | 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. | Population AIM 1 include patients newly diagnosed with fibrosing ILD during the patient identification period and met all the eligibility criteria. Population AIM 1 in this endpoint restricted to patients with sustained oxygen therapy use within 12 months of initiating oxygen therapy patients and with ≥ 11 claims for oxygen therapy within 12 months of initiating oxygen therapy. | Posted | Count of Participants | Participants | Up to month 12 of follow-up, in patient identification period from 01 October 2016 through 30 June 2022. |
|
|
|
| Primary | 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. | Population AIM 1 include patients newly diagnosed with fibrosing ILD during the patient identification period and met all the eligibility criteria. Population AIM 1 in this endpoint restricted to patients with sustained oxygen therapy use within 12 months of initiating oxygen therapy patients and with ≥ 11 claims for oxygen therapy within 12 months of initiating oxygen therapy. | Posted | Median | Inter-Quartile Range | Days | Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)). |
|
|
|
| Primary | 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. | Among the 24,686 fibrosing Interstitial Lung Disease (ILD) patients who initiated oxygen therapy during the Aim 1 follow-up period, 24,680 were successfully matched at a 1:1 ratio with a fibrosing ILD patient who did not yet initiate oxygen therapy. Patients of the matched cohort are included for which pre-index and follow-up forced vital capacity (FVC) results were available. | Posted | Count of Participants | Participants | Up to 12 months prior to the index date (between 01 October 2016 through 30 June 2022 (patient identification period)). |
|
|
|
| Primary | 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. | Among the 24,686 fibrosing Interstitial Lung Disease (ILD) patients who initiated oxygen therapy during the Aim 1 follow-up period, 24,680 were successfully matched at a 1:1 ratio with a fibrosing ILD patient who did not yet initiate oxygen therapy. Patients of the matched cohort are included for which pre-index and follow-up forced vital capacity (FVC) results were available. | Posted | Count of Participants | Participants | Up to month 12 of follow-up, in patient identification period from 01 October 2016 through 30 June 2022. |
|
|
|
| Primary | 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. | Population AIM 2 include ILD patients with ≥1 medical claim for oxygen therapy after fibrosing ILD diagnosis of patients identified for AIM 1 and patients of AIM 1 who matched by propensity score matching (PSM) procedure. For each oxygen therapy cohort patient, a patient who had not yet initiated oxygen therapy and with the closest available propensity score was selected. | Posted | Median | 95% Confidence Interval | Months | Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)). |
|
|
|
| Secondary | Percentage of Participants With Hypoxemia in the Pre-Interstitial Lung Disease (ILD) Baseline 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. | Population AIM 2 include ILD patients with ≥1 medical claim for oxygen therapy after fibrosing ILD diagnosis of patients identified for AIM 1 and patients of AIM 1 who matched by propensity score matching (PSM) procedure. For each oxygen therapy cohort patient, a patient who had not yet initiated oxygen therapy and with the closest available propensity score was selected. | Posted | Number | Percentage of Participants | Up to 12 months prior to the fibrosing ILD diagnosis date (between 01 October 2016 through 30 June 2022 (patient identification period)). |
|
|
|
| Secondary | Percentage of Participants With Hypoxemia in the Pre-index Baseline 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. | Population AIM 2 include ILD patients with ≥1 medical claim for oxygen therapy after fibrosing ILD diagnosis of patients identified for AIM 1 and patients of AIM 1 who matched by propensity score matching (PSM) procedure. For each oxygen therapy cohort patient, a patient who had not yet initiated oxygen therapy and with the closest available propensity score was selected. | Posted | Number | Percentage of Participants | Up to 12 months prior to the index date (between 01 October 2016 through 30 June 2022 (patient identification period)). |
|
|
|
| Secondary | Percentage of Participants With Acute Exacerbations Within the First 12 Month of the Follow up 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. | Population AIM 2 include ILD patients with ≥1 medical claim for oxygen therapy after fibrosing ILD diagnosis of patients identified for AIM 1 and patients of AIM 1 who matched by propensity score matching (PSM) procedure. For each oxygen therapy cohort patient, a patient who had not yet initiated oxygen therapy and with the closest available propensity score was selected. | Posted | Number | Percentage of Participants | Up to 12 months post index date (between 01 October 2016 through 30 June 2022 (patient identification period)). |
|
|
|
| Secondary | Percentage of Participants With Acute Exacerbations in the Pre-index Baseline 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. | Population AIM 2 include ILD patients with ≥1 medical claim for oxygen therapy after fibrosing ILD diagnosis of patients identified for AIM 1 and patients of AIM 1 who matched by propensity score matching (PSM) procedure. For each oxygen therapy cohort patient, a patient who had not yet initiated oxygen therapy and with the closest available propensity score was selected. | Posted | Number | Percentage of Participants | Up to 12 months prior to the index date (between 01 October 2016 through 30 June 2022 (patient identification period)). |
|
|
|
| 21,503 |
| 114,921 |
| 0 |
| 0 |
| 0 |
| 0 |
Not provided
Not provided
Not provided