Trial Outcomes & Findings for Oxygen Therapy Use in Patients With Fibrotic Interstitial Lung Disease (NCT NCT05957198)
NCT ID: NCT05957198
Last Updated: 2024-11-21
Results Overview
Time from the fibrosing Interstitial Lung Disease (ILD) diagnosis date to oxygen therapy initiation is reported. Descriptive statistics are rounded to one decimal place.
COMPLETED
114921 participants
Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)).
2024-11-21
Participant Flow
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).
All subjects were screened for eligibility prior to participation in the trial.
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
114921
|
|
Overall Study
COMPLETED
|
114921
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxygen Therapy Use in Patients With Fibrotic Interstitial Lung Disease
Baseline characteristics by cohort
| Measure |
Patients With Fibrotic Interstitial Lung Disease (ILD)
n=114921 Participants
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).
|
|---|---|
|
Age, Continuous
|
66.9 Years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60669 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54252 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5455 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
78150 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
31316 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1824 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11492 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
77744 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
23861 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)).Population: 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.
Time from the fibrosing Interstitial Lung Disease (ILD) diagnosis date to oxygen therapy initiation is reported. Descriptive statistics are rounded to one decimal place.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis (IPF) Cohort
n=4779 Participants
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 ≥2 medical claims with diagnosis for idiopathic pulmonary fibrosis (IPF) in any position during the study period.
|
Non Idiopathic Pulmonary Fibrosis (IPF) Cohort
n=88799 Participants
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.
|
|---|---|---|
|
Time to Oxygen Therapy Initiation
|
27.5 Months
Interval 25.4 to 29.6
|
NA Months
Due to the insufficient number of events the median could not be calculated.
|
PRIMARY outcome
Timeframe: Up to month 12 of follow-up, in patient identification period from 01 October 2016 through 30 June 2022.Population: 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.
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.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis (IPF) Cohort
n=1339 Participants
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 ≥2 medical claims with diagnosis for idiopathic pulmonary fibrosis (IPF) in any position during the study period.
|
Non Idiopathic Pulmonary Fibrosis (IPF) Cohort
n=10592 Participants
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.
|
|---|---|---|
|
Sustained Oxygen Therapy Use Within the First 12 Months of Follow-up
|
967 Participants
|
4973 Participants
|
PRIMARY outcome
Timeframe: Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)).Population: 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.
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.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis (IPF) Cohort
n=967 Participants
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 ≥2 medical claims with diagnosis for idiopathic pulmonary fibrosis (IPF) in any position during the study period.
|
Non Idiopathic Pulmonary Fibrosis (IPF) Cohort
n=4973 Participants
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.
|
|---|---|---|
|
Time to Sustained Oxygen Therapy Use
|
275 Days
Interval 184.0 to 305.0
|
266 Days
Interval 142.0 to 305.0
|
PRIMARY outcome
Timeframe: Up to 12 months prior to the index date (between 01 October 2016 through 30 June 2022 (patient identification period)).Population: 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.
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.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis (IPF) Cohort
n=24680 Participants
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 ≥2 medical claims with diagnosis for idiopathic pulmonary fibrosis (IPF) in any position during the study period.
|
Non Idiopathic Pulmonary Fibrosis (IPF) Cohort
n=24680 Participants
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.
|
|---|---|---|
|
Number of Participants With Disease Progression From Pre-index Forced Vital Capacity (FVC) Result to Index Date
|
162 Participants
|
110 Participants
|
PRIMARY outcome
Timeframe: Up to month 12 of follow-up, in patient identification period from 01 October 2016 through 30 June 2022.Population: 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.
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.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis (IPF) Cohort
n=24680 Participants
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 ≥2 medical claims with diagnosis for idiopathic pulmonary fibrosis (IPF) in any position during the study period.
|
Non Idiopathic Pulmonary Fibrosis (IPF) Cohort
n=24680 Participants
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.
|
|---|---|---|
|
Number of Participants With Disease Progression From Index Date to Follow-up Forced Vital Capacity (FVC) Result
|
575 Participants
|
456 Participants
|
PRIMARY outcome
Timeframe: Up to 2099 days (from 01 October 2016 through 30 June 2022 (patient identification period)).Population: 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.
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.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis (IPF) Cohort
n=24680 Participants
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 ≥2 medical claims with diagnosis for idiopathic pulmonary fibrosis (IPF) in any position during the study period.
|
Non Idiopathic Pulmonary Fibrosis (IPF) Cohort
n=24680 Participants
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.
|
|---|---|---|
|
Time to All-cause Mortality
|
53.8 Months
Interval 50.8 to 56.5
|
NA Months
Due to the insufficient number of events the median could not be calculated.
|
SECONDARY outcome
Timeframe: Up to 12 months prior to the fibrosing ILD diagnosis date (between 01 October 2016 through 30 June 2022 (patient identification period)).Population: 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.
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.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis (IPF) Cohort
n=24680 Participants
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 ≥2 medical claims with diagnosis for idiopathic pulmonary fibrosis (IPF) in any position during the study period.
|
Non Idiopathic Pulmonary Fibrosis (IPF) Cohort
n=24680 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Hypoxemia in the Pre-Interstitial Lung Disease (ILD) Baseline Period
|
19.9 Percentage of Participants
|
14.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 12 months prior to the index date (between 01 October 2016 through 30 June 2022 (patient identification period)).Population: 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.
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.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis (IPF) Cohort
n=24680 Participants
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 ≥2 medical claims with diagnosis for idiopathic pulmonary fibrosis (IPF) in any position during the study period.
|
Non Idiopathic Pulmonary Fibrosis (IPF) Cohort
n=24680 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Hypoxemia in the Pre-index Baseline Period
|
57.2 Percentage of Participants
|
21.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 12 months post index date (between 01 October 2016 through 30 June 2022 (patient identification period)).Population: 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.
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.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis (IPF) Cohort
n=24680 Participants
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 ≥2 medical claims with diagnosis for idiopathic pulmonary fibrosis (IPF) in any position during the study period.
|
Non Idiopathic Pulmonary Fibrosis (IPF) Cohort
n=24680 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Acute Exacerbations Within the First 12 Month of the Follow up Period
|
3.5 Percentage of Participants
|
1.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 12 months prior to the index date (between 01 October 2016 through 30 June 2022 (patient identification period)).Population: 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.
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.
Outcome measures
| Measure |
Idiopathic Pulmonary Fibrosis (IPF) Cohort
n=24680 Participants
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 ≥2 medical claims with diagnosis for idiopathic pulmonary fibrosis (IPF) in any position during the study period.
|
Non Idiopathic Pulmonary Fibrosis (IPF) Cohort
n=24680 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Acute Exacerbations in the Pre-index Baseline Period
|
2.8 Percentage of Participants
|
1.3 Percentage of Participants
|
Adverse Events
Patients With Fibrotic Interstitial Lung Disease (ILD)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place