Trial Outcomes & Findings for A Study to Characterize the Disease Behavior of Idiopathic Pulmonary Fibrosis (IPF) and Interstitial Lung Disease (ILD) During the Peri-Diagnostic Period (NCT NCT03261037)

NCT ID: NCT03261037

Last Updated: 2021-03-26

Results Overview

Minimum site visits were: baseline, diagnosis, and EOS for each participant. From inclusion into the study, participants were followed for up to12 months. The EOS was defined as: If no diagnosis was made 12 months after inclusion, the participant left the study; Participants diagnosed with non-ILD left the study on the date of diagnosis; Participants diagnosed with IPF or non-IPF ILD were followed up to the start of drug treatment (within 6 months) or up to 6 months if no drug treatment was prescribed. Therefore, the total length of the study was variable for each participant. Measurements were taken daily by home spirometry. The semi-annual mean FVC decline was calculated by use of the estimated semi-annual FVC decline of each individual participant. The individual FVC decline was estimated by applying a linear regression model to all acceptable FVC measurements flagged as 'Good blow' collected by the individual participant during the entire peri-diagnostic period (up to 18 months).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 178 participants
• Primary outcome timeframe: From Day 1 into the study to end of the study (up to 18 months) and adjusted for 6 months. There was no fixed visit schedule for the whole study and reported results comprise all data points from enrollment to EOS
• Results posted on: 2021-03-26

Participant Flow

The study enrolled participants in Canada, France, Ireland, Italy, the Netherlands, and Russia.

Participant milestones

Measure	IPF Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis Participants without diagnosis
Overall Study STARTED	68	62	9	39
Overall Study COMPLETED	64	41	9	11
Overall Study NOT COMPLETED	4	21	0	28

Reasons for withdrawal

Measure	IPF Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis Participants without diagnosis
Overall Study Withdrawal by Subject	2	13	0	18
Overall Study Non-compliance with study procedures	0	2	0	6
Overall Study Participant moving away and can no longer be in study	0	1	0	0
Overall Study Participant came out of study due to investigator discretion	0	2	0	0
Overall Study Diagnosed but protocol deviation	1	0	0	0
Overall Study Participant did not want to continue the study	0	1	0	0
Overall Study Participant did not want to continue the diagnostic procedures	0	0	0	1
Overall Study Participant presented clinical improvement	0	2	0	0
Overall Study Technical difficulties	0	0	0	1
Overall Study Equipment failed to work	0	0	0	1
Overall Study End of study for participant and no follow up	0	0	0	1
Overall Study Participant was too weak to continue in study	1	0	0	0

Baseline Characteristics

A Study to Characterize the Disease Behavior of Idiopathic Pulmonary Fibrosis (IPF) and Interstitial Lung Disease (ILD) During the Peri-Diagnostic Period

Baseline characteristics by cohort

Measure	IPF Participants n=68 Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants n=62 Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants n=9 Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis n=39 Participants Participants without diagnosis	Total n=178 Participants Total of all reporting groups
Age, Continuous	69.3 Years STANDARD_DEVIATION 6.97 • n=5 Participants	65.1 Years STANDARD_DEVIATION 9.99 • n=7 Participants	69.6 Years STANDARD_DEVIATION 7.7 • n=5 Participants	71.2 Years STANDARD_DEVIATION 8.64 • n=4 Participants	68.3 Years STANDARD_DEVIATION 8.8 • n=21 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	32 Participants n=7 Participants	3 Participants n=5 Participants	12 Participants n=4 Participants	66 Participants n=21 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	30 Participants n=7 Participants	6 Participants n=5 Participants	27 Participants n=4 Participants	112 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized White	62 Participants n=5 Participants	50 Participants n=7 Participants	7 Participants n=5 Participants	24 Participants n=4 Participants	143 Participants n=21 Participants
Race/Ethnicity, Customized Unknown	1 Participant n=5 Participants	0 Participant n=7 Participants	0 Participant n=5 Participants	1 Participant n=4 Participants	2 Participant n=21 Participants
Race/Ethnicity, Customized Missing	5 Participant n=5 Participants	11 Participant n=7 Participants	2 Participant n=5 Participants	15 Participant n=4 Participants	33 Participant n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino	9 Participant n=5 Participants	12 Participant n=7 Participants	0 Participant n=5 Participants	1 Participant n=4 Participants	22 Participant n=21 Participants
Race/Ethnicity, Customized Not Hispanic or Latin	49 Participant n=5 Participants	36 Participant n=7 Participants	7 Participant n=5 Participants	20 Participant n=4 Participants	112 Participant n=21 Participants
Race/Ethnicity, Customized Not reported	4 Participant n=5 Participants	3 Participant n=7 Participants	0 Participant n=5 Participants	2 Participant n=4 Participants	9 Participant n=21 Participants

PRIMARY outcome

Timeframe: From Day 1 into the study to end of the study (up to 18 months) and adjusted for 6 months. There was no fixed visit schedule for the whole study and reported results comprise all data points from enrollment to EOS

Population: Participants diagnosed with IPF. Only participants for whom data were collected are included in the analysis.

Minimum site visits were: baseline, diagnosis, and EOS for each participant. From inclusion into the study, participants were followed for up to12 months. The EOS was defined as: If no diagnosis was made 12 months after inclusion, the participant left the study; Participants diagnosed with non-ILD left the study on the date of diagnosis; Participants diagnosed with IPF or non-IPF ILD were followed up to the start of drug treatment (within 6 months) or up to 6 months if no drug treatment was prescribed. Therefore, the total length of the study was variable for each participant. Measurements were taken daily by home spirometry. The semi-annual mean FVC decline was calculated by use of the estimated semi-annual FVC decline of each individual participant. The individual FVC decline was estimated by applying a linear regression model to all acceptable FVC measurements flagged as 'Good blow' collected by the individual participant during the entire peri-diagnostic period (up to 18 months).

Outcome measures

Measure	IPF Participants n=64 Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis Participants without diagnosis
Time-Adjusted Semi-Annual Forced Vital Capacity (FVC) Decline in Participants With IPF During the Peri-Diagnostic Period, Measured in Milliliters (mL) by Daily Home Spirometry	-308.7 milliliter (mL) Standard Deviation 1268.72	—	—	—

SECONDARY outcome

Timeframe: From Day 1 into the study to end of the study (up to 18 months) and adjusted for 6 months. There was no fixed visit schedule for the whole study and reported results comprise all data points from enrollment to EOS

Population: Participants diagnosed with non-IPF ILD. Only participants for whom data were collected are included in the analysis.

Minimum site visits were: baseline, diagnosis, and EOS for each participant. From inclusion into the study, participants were followed for up to12 months. The EOS was defined as: If no diagnosis was made 12 months after inclusion, the participant left the study; Participants diagnosed with non-ILD left the study on the date of diagnosis; Participants diagnosed with IPF or non-IPF ILD were followed up to the start of drug treatment (within 6 months) or up to 6 months if no drug treatment was prescribed. Therefore, the total length of the study was variable for each participant. Measurements were taken daily by home spirometry. The semi-annual mean FVC decline was calculated by use of the estimated semi-annual FVC decline of each individual participant. The individual FVC decline was estimated by applying a linear regression model to all acceptable FVC measurements flagged as 'Good blow' collected by the individual participant during the entire peri-diagnostic period (up to 18 months).

Outcome measures

Measure	IPF Participants n=59 Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis Participants without diagnosis
Time-Adjusted Semi-Annual FVC Decline in Participants With Non-IPF ILD During the Peri-Diagnostic Period, Measured in mL by Daily Home Spirometry	57.5 mL Standard Deviation 1277.03	—	—	—

SECONDARY outcome

Timeframe: From Baseline to end of the study (up to 18 months)

Population: Participants diagnosed with IPF and non-IPF ILD. Only participants for whom data were collected are included in the analysis.

The peri-diagnostic period covered the pre-diagnostic period (from inclusion into the study (enrollment visit), participants were followed for a maximum of 12 months in the pre-diagnostic assessment period) and the post-diagnostic period (from diagnosis to the start of drug treatment within 6 months or a maximum of 6 months if no drug treatment was prescribed).

Outcome measures

Measure	IPF Participants n=68 Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants n=62 Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis Participants without diagnosis
Change From Baseline in the FVC Decline in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured in mL by Site Spirometry Baseline	2845.6 mL Standard Deviation 814.83	2782.4 mL Standard Deviation 870.24	—	—
Change From Baseline in the FVC Decline in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured in mL by Site Spirometry Change from Baseline at End of Study Visit	-51.3 mL Standard Deviation 270.56	-27.1 mL Standard Deviation 265.52	—	—

SECONDARY outcome

Timeframe: From Baseline to end of the study (up to 18 months)

Population: Participants diagnosed with IPF and non-IPF ILD. Only participants for whom data were collected are included in the analysis.

The peri-diagnostic period covered the pre-diagnostic period (from inclusion into the study (enrollment visit), participants were followed for a maximum of 12 months in the pre-diagnostic assessment period) and the post-diagnostic period (from diagnosis to the start of drug treatment within 6 months or a maximum of 6 months if no drug treatment was prescribed).

Outcome measures

Measure	IPF Participants n=68 Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants n=62 Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis Participants without diagnosis
Change From Baseline in the Percent Predicted FVC in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured by Site Spirometry Baseline	82.8 Percent Predicted (%) Standard Deviation 18.74	83.9 Percent Predicted (%) Standard Deviation 17.82	—	—
Change From Baseline in the Percent Predicted FVC in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured by Site Spirometry Change form Baseline at End of Study Visit	-0.6 Percent Predicted (%) Standard Deviation 7.26	-0.6 Percent Predicted (%) Standard Deviation 8.49	—	—

SECONDARY outcome

Timeframe: From Baseline to end of the study (up to 18 months)

Population: Participants diagnosed with IPF and non-IPF ILD. Only participants for whom data were collected are included in the analysis.

The 6MWT measures the distance a patient is able to walk quickly on a flat, hard surface in a period of 6 minutes. The peri-diagnostic period covered the pre-diagnostic period (from inclusion into the study (enrollment visit), participants were followed for a maximum of 12 months in the pre-diagnostic assessment period) and the post-diagnostic period (from diagnosis to the start of drug treatment within 6 months or a maximum of 6 months if no drug treatment was prescribed).

Outcome measures

Measure	IPF Participants n=68 Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants n=62 Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis Participants without diagnosis
Change From Baseline in Distance Walked (Meters) on the 6MWT in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Assessed at Site Baseline	434.6 Meter (m) Standard Deviation 117.30	429.4 Meter (m) Standard Deviation 139.51	—	—
Change From Baseline in Distance Walked (Meters) on the 6MWT in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Assessed at Site Change from Baseline at End of Study Visit	4.4 Meter (m) Standard Deviation 96.18	6.4 Meter (m) Standard Deviation 87.97	—	—

SECONDARY outcome

Timeframe: From inclusion into the study to end of the study (up to 18 months)

Population: Participants diagnosed with IPF and non-IPF ILD. Only participants for whom data were collected are included in the analysis.

Patients were asked to wear an accelerometer during the course of the study which provided information on their physical activity at home, with daily measurements used to investigate the development of physical function capacity. The peri-diagnostic period covered the pre-diagnostic period (from inclusion into the study (enrollment visit), participants were followed for a maximum of 12 months in the pre-diagnostic assessment period) and the post-diagnostic period (from diagnosis to the start of drug treatment within 6 months or a maximum of 6 months if no drug treatment was prescribed).

Outcome measures

Measure	IPF Participants n=66 Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants n=61 Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis Participants without diagnosis
Decline in Physical Function Capacity (Steps/Day) in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured by Daily Home Accelerometry	-1237.2 Steps per Day Standard Deviation 14146.07	-13407.3 Steps per Day Standard Deviation 72612.82	—	—

SECONDARY outcome

Timeframe: From inclusion into the study to end of the study (up to 18 months)

Population: Data collection was impacted by technical problems that could not be solved, thus invalid data collected was not analyzed.

Outcome measures

Measure	IPF Participants n=68 Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants n=62 Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis Participants without diagnosis
Calorie Expenditure in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured by Daily Home Accelerometry	NA Calorie Calorie expenditure device was malfunctioning and unreliable data were collected, which was not suitable to analyse therefore there was no analysis done.	NA Calorie Calorie expenditure device was malfunctioning and unreliable data were collected, which was not suitable to analyse therefore there was no analysis done.	—	—

SECONDARY outcome

Timeframe: From inclusion into the study to end of the study (up to 18 months)

Population: All enrolled participants completed the questionnaire. Only participants for whom data were collected are included in the analysis.

The K-BILD questionnaire was specifically developed to analyze the health status of participants with ILD. The questionnaire consists of 15 items (assessed by the patients on a scale ranging from 1 to 7, where 1 and 7 represent worst and best health status). Items are compiled into 3 domains: breathlessness and activities (range: 0-21), psychological (range: 0-34) , and chest symptoms (range: 0-8). To score the K-BILD, the Likert response scale weightings for individual items are combined and scores are transformed to a range of 0-100 by using logit values (higher scores indicate better health status). The peri-diagnostic period covered the pre-diagnostic period (from enrollment visit participants were followed for up to 12 months) and the post-diagnostic period (from diagnosis to the start of drug treatment within 6 months or a maximum of 6 months if no drug treatment was prescribed).

Outcome measures

Measure	IPF Participants n=68 Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants n=62 Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants n=9 Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis n=39 Participants Participants without diagnosis
Change in the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Total Score by Visit During the Peri-Diagnostic Period Change from Baseline at End of Study Visit	-0.45 Units on scale Standard Deviation 9.709	3.98 Units on scale Standard Deviation 11.851	6.03 Units on scale Standard Deviation 14.294	4.01 Units on scale Standard Deviation 9.313
Change in the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Total Score by Visit During the Peri-Diagnostic Period Baseline	60.57 Units on scale Standard Deviation 17.633	55.70 Units on scale Standard Deviation 14.203	54.22 Units on scale Standard Deviation 11.703	60.47 Units on scale Standard Deviation 15.728

SECONDARY outcome

Timeframe: From inclusion into the study to end of the study (up to 18 months)

Population: All enrolled participants. Only participants for whom data were collected are included in the analysis. Data of post-diagnosis period for non-ILD participants and participants without diagnosis were not collected.

The mMRC dyspnea scale was used to grade the effects of breathlessness on daily activities over time. The following grading categories are used for this scale: Grade 0 - I only get breathless with strenuous exercise; Grade 1 - I get short of breath when hurrying on the level or walking up a slight hill; Grade 2 - I walk slower than people of the same age on the level because of breathlessness or have to stop for breath when walking on my own pace; Grade 3 - I stop for breath after walking about 100 yards or after a few minutes on level ground; Grade 4 - I am too breathless to leave the house. The peri-diagnostic period covered the pre-diagnostic period (from inclusion into the study (enrollment visit), participants were followed for a maximum of 12 months in the pre-diagnostic assessment period) and the post-diagnostic period (from diagnosis to the start of drug treatment within 6 months or a maximum of 6 months if no drug treatment was prescribed).

Outcome measures

Measure	IPF Participants n=68 Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants n=61 Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants n=9 Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis n=32 Participants Participants without diagnosis
Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period Pre-diagnosis · Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period Initial diagnosis · Grade 0	22 Participants	17 Participants	3 Participants	2 Participants
Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period Initial diagnosis · Grade 1	31 Participants	25 Participants	0 Participants	0 Participants
Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period Initial diagnosis · Grade 2	10 Participants	16 Participants	3 Participants	1 Participants
Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period Initial diagnosis · Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period Post-diagnosis · Grade 0	2 Participants	1 Participants	—	—
Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period Post-diagnosis · Grade 1	4 Participants	2 Participants	—	—
Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period Post-diagnosis · Grade 4	0 Participants	0 Participants	—	—
Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period End of Study · Grade 0	20 Participants	17 Participants	3 Participants	13 Participants
Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period End of Study · Grade 1	30 Participants	25 Participants	1 Participants	15 Participants
Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period End of Study · Grade 2	10 Participants	16 Participants	3 Participants	3 Participants
Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period End of Study · Grade 3	5 Participants	3 Participants	2 Participants	1 Participants
Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period End of Study · Grade 4	0 Participants	0 Participants	0 Participants	0 Participants
Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period Pre-diagnosis · Grade 2	7 Participants	9 Participants	3 Participants	2 Participants
Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period Pre-diagnosis · Grade 3	3 Participants	2 Participants	1 Participants	1 Participants
Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period Pre-diagnosis · Grade 0	12 Participants	10 Participants	2 Participants	6 Participants
Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period Pre-diagnosis · Grade 1	8 Participants	8 Participants	1 Participants	11 Participants
Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period Initial diagnosis · Grade 3	5 Participants	3 Participants	2 Participants	0 Participants
Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period Post-diagnosis · Grade 2	0 Participants	0 Participants	—	—
Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period Post-diagnosis · Grade 3	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: From inclusion into the study to end of the study (up to 18 months)

Population: All enrolled participants. Data of post-diagnosis period for non-ILD participants and participants without diagnosis were not collected as participants already discontinued from the study.

The EQ-5D-5L questionnaire is a self-reported health status questionnaire that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item is rated by the participant on a five-point scale indicating the followings: Level 1 - no problem; Level 2 - slight problems; Level 3 - moderate problems; Level 4 - severe problems; Level 5 - extreme problems. The peri-diagnostic period covered the pre-diagnostic period (from inclusion into the study (enrollment visit), participants were followed for a maximum of 12 months in the pre-diagnostic assessment period) and the post-diagnostic period (from diagnosis to the start of drug treatment within 6 months or a maximum of 6 months if no drug treatment was prescribed).

Outcome measures

Measure	IPF Participants n=68 Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants n=62 Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants n=9 Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis n=38 Participants Participants without diagnosis
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Mobility · Level 4	0 Participants	0 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Mobility · Level 5	0 Participants	0 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Mobility · Missing	1 Participants	0 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Self-care · Level 1	4 Participants	2 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Self-care · Level 2	0 Participants	1 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Self-care · Level 3	1 Participants	0 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Self-care · Level 4	0 Participants	0 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Self-care · Level 5	0 Participants	0 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Self-care · Missing	1 Participants	0 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Usual activities · Level 1	2 Participants	2 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Usual activities · Level 2	2 Participants	0 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Usual activities · Level 3	1 Participants	1 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Usual activities · Level 4	0 Participants	0 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Usual activities · Level 5	0 Participants	0 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Usual activities · Missing	1 Participants	0 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Pain/Discomfort · Level 1	1 Participants	2 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Pain/Discomfort · Level 2	4 Participants	0 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Pain/Discomfort · Level 3	0 Participants	1 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Pain/Discomfort · Level 4	0 Participants	0 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Pain/Discomfort · Level 5	0 Participants	0 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Pain/Discomfort · Missing	1 Participants	0 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Anxiety/Depression · Level 1	3 Participants	0 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Anxiety/Depression · Level 2	1 Participants	2 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Anxiety/Depression · Level 3	1 Participants	1 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Anxiety/Depression · Level 4	0 Participants	0 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Anxiety/Depression · Level 5	0 Participants	0 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Anxiety/Depression · Missing	1 Participants	0 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Mobility · Level 1	33 Participants	28 Participants	2 Participants	16 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Mobility · Level 2	15 Participants	15 Participants	3 Participants	2 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Mobility · Level 3	11 Participants	14 Participants	3 Participants	4 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Mobility · Level 4	4 Participants	3 Participants	1 Participants	2 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Mobility · Level 5	0 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Mobility · Missing	2 Participants	2 Participants	0 Participants	9 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Self-care · Level 1	54 Participants	46 Participants	6 Participants	22 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Self-care · Level 2	3 Participants	12 Participants	2 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Self-care · Level 3	5 Participants	2 Participants	1 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Self-care · Level 4	1 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Self-care · Level 5	0 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Self-care · Missing	2 Participants	2 Participants	0 Participants	9 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Usual activities · Level 1	32 Participants	25 Participants	4 Participants	14 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Usual activities · Level 2	16 Participants	18 Participants	0 Participants	5 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Usual activities · Level 3	11 Participants	15 Participants	4 Participants	4 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Usual activities · Level 4	3 Participants	2 Participants	1 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Usual activities · Level 5	1 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Usual activities · Missing	2 Participants	2 Participants	0 Participants	9 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Pain/Discomfort · Level 1	30 Participants	34 Participants	2 Participants	14 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Pain/Discomfort · Level 2	20 Participants	16 Participants	1 Participants	3 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Pain/Discomfort · Level 3	13 Participants	8 Participants	4 Participants	6 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Pain/Discomfort · Level 4	0 Participants	2 Participants	2 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Pain/Discomfort · Level 5	0 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Pain/Discomfort · Missing	2 Participants	2 Participants	0 Participants	9 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Anxiety/Depression · Level 1	28 Participants	25 Participants	4 Participants	13 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Anxiety/Depression · Level 2	21 Participants	19 Participants	1 Participants	10 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Anxiety/Depression · Level 3	10 Participants	15 Participants	2 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Anxiety/Depression · Level 4	2 Participants	1 Participants	2 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Anxiety/Depression · Level 5	2 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period End of Study Anxiety/Depression · Missing	2 Participants	2 Participants	0 Participants	9 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Mobility · Level 1	31 Participants	26 Participants	2 Participants	2 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Mobility · Level 2	16 Participants	15 Participants	2 Participants	9 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Mobility · Missing	0 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Self-care · Level 1	55 Participants	52 Participants	6 Participants	34 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Usual activities · Level 2	19 Participants	16 Participants	2 Participants	10 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Usual activities · Level 4	1 Participants	2 Participants	0 Participants	4 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Pain/Discomfort · Level 3	17 Participants	14 Participants	3 Participants	4 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Anxiety/Depression · Level 2	22 Participants	20 Participants	2 Participants	12 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Anxiety/Depression · Missing	0 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Mobility · Level 4	1 Participants	3 Participants	2 Participants	2 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Self-care · Level 2	3 Participants	2 Participants	2 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Self-care · Level 3	1 Participants	1 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Self-care · Level 4	1 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Usual activities · Level 2	10 Participants	6 Participants	3 Participants	6 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Usual activities · Level 3	4 Participants	7 Participants	2 Participants	4 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Pain/Discomfort · Level 1	15 Participants	15 Participants	1 Participants	12 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Pain/Discomfort · Level 5	0 Participants	0 Participants	0 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Pain/Discomfort · Missing	0 Participants	1 Participants	0 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Anxiety/Depression · Level 1	14 Participants	12 Participants	2 Participants	10 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Anxiety/Depression · Level 2	11 Participants	10 Participants	4 Participants	8 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Anxiety/Depression · Level 3	3 Participants	6 Participants	1 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Mobility · Level 2	19 Participants	17 Participants	3 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Mobility · Missing	3 Participants	4 Participants	0 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Self-care · Level 1	55 Participants	44 Participants	6 Participants	2 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Self-care · Level 2	3 Participants	10 Participants	1 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Self-care · Level 5	0 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Usual activities · Level 2	20 Participants	14 Participants	1 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Usual activities · Level 5	1 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Pain/Discomfort · Level 1	32 Participants	34 Participants	2 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Pain/Discomfort · Level 2	22 Participants	14 Participants	1 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Anxiety/Depression · Missing	3 Participants	4 Participants	0 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Pain/Discomfort · Level 5	0 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Pain/Discomfort · Missing	3 Participants	4 Participants	0 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Anxiety/Depression · Level 1	30 Participants	25 Participants	4 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Anxiety/Depression · Level 2	21 Participants	17 Participants	1 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Anxiety/Depression · Level 3	10 Participants	13 Participants	1 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Anxiety/Depression · Level 5	2 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Mobility · Level 1	2 Participants	0 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Mobility · Level 2	1 Participants	2 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Post-diagnosis Mobility · Level 3	2 Participants	1 Participants	—	—
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Self-care · Level 4	0 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Self-care · Level 4	1 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Self-care · Missing	3 Participants	4 Participants	0 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Usual activities · Level 1	31 Participants	27 Participants	6 Participants	2 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Usual activities · Level 3	9 Participants	14 Participants	1 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Usual activities · Level 4	4 Participants	3 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Usual activities · Missing	3 Participants	4 Participants	0 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Mobility · Level 1	33 Participants	25 Participants	2 Participants	24 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Mobility · Level 3	14 Participants	21 Participants	5 Participants	4 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Mobility · Level 4	5 Participants	1 Participants	0 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Mobility · Level 5	0 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Self-care · Level 2	7 Participants	6 Participants	2 Participants	4 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Self-care · Level 3	6 Participants	4 Participants	1 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Self-care · Level 5	0 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Self-care · Missing	0 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Usual activities · Level 1	32 Participants	29 Participants	4 Participants	20 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Usual activities · Level 3	16 Participants	15 Participants	2 Participants	4 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Usual activities · Level 5	0 Participants	0 Participants	1 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Usual activities · Missing	0 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Pain/Discomfort · Level 1	29 Participants	25 Participants	3 Participants	20 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Pain/Discomfort · Level 2	22 Participants	22 Participants	2 Participants	10 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Pain/Discomfort · Level 4	0 Participants	1 Participants	1 Participants	3 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Pain/Discomfort · Level 5	0 Participants	0 Participants	0 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Pain/Discomfort · Missing	0 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Anxiety/Depression · Level 1	38 Participants	24 Participants	5 Participants	19 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Anxiety/Depression · Level 3	5 Participants	15 Participants	2 Participants	7 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Anxiety/Depression · Level 4	2 Participants	2 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Baseline Anxiety/Depression · Level 5	1 Participants	1 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Mobility · Level 1	16 Participants	11 Participants	1 Participants	13 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Mobility · Level 2	4 Participants	9 Participants	2 Participants	4 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Mobility · Level 3	9 Participants	5 Participants	2 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Mobility · Level 5	0 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Mobility · Missing	0 Participants	1 Participants	0 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Self-care · Level 1	25 Participants	25 Participants	5 Participants	20 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Self-care · Level 5	0 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Self-care · Missing	0 Participants	1 Participants	0 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Usual activities · Level 1	15 Participants	15 Participants	2 Participants	9 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Usual activities · Level 4	1 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Usual activities · Level 5	0 Participants	0 Participants	0 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Usual activities · Missing	0 Participants	1 Participants	0 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Pain/Discomfort · Level 2	11 Participants	7 Participants	4 Participants	3 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Pain/Discomfort · Level 3	3 Participants	5 Participants	0 Participants	4 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Pain/Discomfort · Level 4	1 Participants	1 Participants	2 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Pain/Discomfort · Level 3	10 Participants	6 Participants	3 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Anxiety/Depression · Level 4	0 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Anxiety/Depression · Level 5	2 Participants	0 Participants	0 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Pain/Discomfort · Level 4	1 Participants	4 Participants	2 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Pre-diagnosis Anxiety/Depression · Missing	0 Participants	1 Participants	0 Participants	1 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Mobility · Level 3	12 Participants	9 Participants	2 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Mobility · Level 4	3 Participants	6 Participants	1 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Mobility · Level 5	0 Participants	0 Participants	0 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Self-care · Level 3	6 Participants	4 Participants	1 Participants	0 Participants
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period Initial diagnosis Anxiety/Depression · Level 4	2 Participants	3 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: From inclusion into the study to end of the study (up to 18 months)

Population: All enrolled participants. Only participants for whom data were collected are included in the analysis. Data of post-diagnosis period for non-ILD participants and participants without diagnosis were not collected.

The EQ-VAS questionnaire is a self-reported questionnaire that measures health state. The VAS is a 100 mm scale from worst (0 mm) to best (100 mm) health the participant can imagine. The peri-diagnostic period covered the pre-diagnostic period (from inclusion into the study (enrollment visit), participants were followed for a maximum of 12 months in the pre-diagnostic assessment period) and the post-diagnostic period (from diagnosis to the start of drug treatment within 6 months or a maximum of 6 months if no drug treatment was prescribed).

Outcome measures

Measure	IPF Participants n=68 Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants n=62 Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants n=9 Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis n=39 Participants Participants without diagnosis
The EuroQol Visual Analogue Scale (EQ-VAS) Health State Profile Scores During the Peri-Diagnostic Period During the Peri-Diagnostic Period Health State Index Baseline	71.7 Scores on a scale Standard Deviation 15.96	67.4 Scores on a scale Standard Deviation 20.11	68.9 Scores on a scale Standard Deviation 17.99	76.2 Scores on a scale Standard Deviation 17.09
The EuroQol Visual Analogue Scale (EQ-VAS) Health State Profile Scores During the Peri-Diagnostic Period During the Peri-Diagnostic Period Health State Index Pre-diagnosis	69.8 Scores on a scale Standard Deviation 15.50	71.5 Scores on a scale Standard Deviation 15.89	65.7 Scores on a scale Standard Deviation 19.88	73.5 Scores on a scale Standard Deviation 16.06
The EuroQol Visual Analogue Scale (EQ-VAS) Health State Profile Scores During the Peri-Diagnostic Period During the Peri-Diagnostic Period Health State Index Initial diagnosis	69.5 Scores on a scale Standard Deviation 16.23	68.3 Scores on a scale Standard Deviation 18.03	70.4 Scores on a scale Standard Deviation 19.92	72.5 Scores on a scale Standard Deviation 10.61
The EuroQol Visual Analogue Scale (EQ-VAS) Health State Profile Scores During the Peri-Diagnostic Period During the Peri-Diagnostic Period Health State Index Post-diagnosis	69.0 Scores on a scale Standard Deviation 25.10	76.7 Scores on a scale Standard Deviation 12.58	—	—
The EuroQol Visual Analogue Scale (EQ-VAS) Health State Profile Scores During the Peri-Diagnostic Period During the Peri-Diagnostic Period Health State Index End of Study	69.5 Scores on a scale Standard Deviation 16.46	69.8 Scores on a scale Standard Deviation 17.21	67.0 Scores on a scale Standard Deviation 21.21	74.2 Scores on a scale Standard Deviation 16.85

SECONDARY outcome

Timeframe: From inclusion into the study to end of the study (up to 18 months)

Population: All enrolled participants. Only participants for whom data were collected are included in the analysis. Data of post-diagnosis period for non-ILD participants and participants without diagnosis were not collected.

The EQ-5D-5L questionnaire is a self-reported health status questionnaire that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A unique health state is defined for each participant by combining the levels from each of the 5 dimensions. Each state is referred to in terms of a 5 digit code, e.g. state 11111 indicates no problems on any of the 5 dimensions, while state 12345 indicates no problems with mobility, slight problems with washing or dressing, moderate problems with usual activities, severe pain or discomfort and extreme anxiety or depression. From these 5 answers an index value is derived between 0 and 1, with a higher value corresponding with a better Quality of Life.

Outcome measures

Measure	IPF Participants n=68 Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants n=62 Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants n=9 Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis n=39 Participants Participants without diagnosis
The EuroQoL 5-dimension 5-level Questionnaire Index Utility Scores During the Peri-Diagnostic Period Index utility score Baseline	0.83 Scores on a scale Standard Deviation 0.140	0.79 Scores on a scale Standard Deviation 0.143	0.67 Scores on a scale Standard Deviation 0.250	0.80 Scores on a scale Standard Deviation 0.187
The EuroQoL 5-dimension 5-level Questionnaire Index Utility Scores During the Peri-Diagnostic Period Index utility score Pre-diagnosis	0.82 Scores on a scale Standard Deviation 0.154	0.80 Scores on a scale Standard Deviation 0.152	0.68 Scores on a scale Standard Deviation 0.237	0.83 Scores on a scale Standard Deviation 0.182
The EuroQoL 5-dimension 5-level Questionnaire Index Utility Scores During the Peri-Diagnostic Period Index utility score Initial diagnosis	0.81 Scores on a scale Standard Deviation 0.162	0.78 Scores on a scale Standard Deviation 0.197	0.63 Scores on a scale Standard Deviation 0.331	0.92 Scores on a scale Standard Deviation 0.013
The EuroQoL 5-dimension 5-level Questionnaire Index Utility Scores During the Peri-Diagnostic Period Index utility score Post-diagnosis	0.81 Scores on a scale Standard Deviation 0.149	0.75 Scores on a scale Standard Deviation 0.123	—	—
The EuroQoL 5-dimension 5-level Questionnaire Index Utility Scores During the Peri-Diagnostic Period Index utility score End of Study	0.81 Scores on a scale Standard Deviation 0.164	0.80 Scores on a scale Standard Deviation 0.164	0.62 Scores on a scale Standard Deviation 0.312	0.81 Scores on a scale Standard Deviation 0.197

SECONDARY outcome

Timeframe: From inclusion into the study to end of the study (up to 18 months)

Population: All enrolled participants. Only participants for whom data were collected are included in the analysis. Data of post-diagnosis period for non-ILD participants and participants without diagnosis were not collected.

The FAS is a fatigue questionnaire consisting of 10 items; five questions reflect physical fatigue and five questions analyze mental fatigue. A five-point scale (one for "never" to five for "always") is used for participant responses. The scale score is calculated by summing all items. Therefore, the FAS scores can range from 10 to 50. The peri-diagnostic period covered the pre-diagnostic period (from inclusion into the study (enrollment visit), participants were followed for a maximum of 12 months in the pre-diagnostic assessment period) and the post-diagnostic period (from diagnosis to the start of drug treatment within 6 months or a maximum of 6 months if no drug treatment was prescribed).

Outcome measures

Measure	IPF Participants n=68 Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants n=62 Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants n=9 Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis n=39 Participants Participants without diagnosis
Fatigue Assessment Scale (FAS) Score During the Peri-Diagnostic Period Baseline	21.8 Scores on a Scale Standard Deviation 6.44	21.8 Scores on a Scale Standard Deviation 6.89	21.1 Scores on a Scale Standard Deviation 7.22	20.9 Scores on a Scale Standard Deviation 6.99
Fatigue Assessment Scale (FAS) Score During the Peri-Diagnostic Period Initial diagnosis	21.7 Scores on a Scale Standard Deviation 6.66	22.6 Scores on a Scale Standard Deviation 7.33	24.7 Scores on a Scale Standard Deviation 9.11	18.0 Scores on a Scale Standard Deviation 2.83
Fatigue Assessment Scale (FAS) Score During the Peri-Diagnostic Period End of study	22.0 Scores on a Scale Standard Deviation 6.17	22.0 Scores on a Scale Standard Deviation 7.59	26.1 Scores on a Scale Standard Deviation 9.33	20.6 Scores on a Scale Standard Deviation 6.31

SECONDARY outcome

Timeframe: From inclusion into the study to end of the study (up to 18 months)

Population: All enrolled participants. Only participants for whom data were collected are included in the analysis. Data of post-diagnosis period for non-ILD participants and participants without diagnosis were not collected.

The VAS are 100 mm scales on which participants indicate the severity of their cough, the urge to cough and their fatigue. In the VAS, participants had to record their health state on a scale ranging from 0 (best imaginable health state) to 100 (worst imaginable health state). A mean of this health state was recorded for participant analyzed in this outcome measure. The peri-diagnostic period covered the pre-diagnostic period (from inclusion into the study (enrollment visit), participants were followed for a maximum of 12 months in the pre-diagnostic assessment period) and the post-diagnostic period (from diagnosis to the start of drug treatment within 6 months or a maximum of 6 months if no drug treatment was prescribed).

Outcome measures

Measure	IPF Participants n=68 Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants n=62 Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants n=9 Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis n=39 Participants Participants without diagnosis
Cough, Urge to Cough, and Fatigue Visual Analogue Scales (VAS) Score During the Peri-Diagnostic Period Baseline (Cough)	34.0 Scores on a Scale Standard Deviation 25.44	26.9 Scores on a Scale Standard Deviation 20.66	17.9 Scores on a Scale Standard Deviation 21.99	27.4 Scores on a Scale Standard Deviation 20.38
Cough, Urge to Cough, and Fatigue Visual Analogue Scales (VAS) Score During the Peri-Diagnostic Period Pre-diagnosis (Cough)	36.8 Scores on a Scale Standard Deviation 25.50	25.4 Scores on a Scale Standard Deviation 20.90	11.4 Scores on a Scale Standard Deviation 14.03	31.4 Scores on a Scale Standard Deviation 24.34
Cough, Urge to Cough, and Fatigue Visual Analogue Scales (VAS) Score During the Peri-Diagnostic Period Initial diagnosis (Cough)	36.3 Scores on a Scale Standard Deviation 29.60	21.9 Scores on a Scale Standard Deviation 18.88	17.1 Scores on a Scale Standard Deviation 21.69	32.0 Scores on a Scale Standard Deviation 36.77
Cough, Urge to Cough, and Fatigue Visual Analogue Scales (VAS) Score During the Peri-Diagnostic Period Post-diagnosis (Cough)	25.6 Scores on a Scale Standard Deviation 20.94	17.0 Scores on a Scale Standard Deviation 9.16	—	—
Cough, Urge to Cough, and Fatigue Visual Analogue Scales (VAS) Score During the Peri-Diagnostic Period End of Study (Cough)	34.7 Scores on a Scale Standard Deviation 26.64	24.0 Scores on a Scale Standard Deviation 19.42	19.3 Scores on a Scale Standard Deviation 21.35	31.2 Scores on a Scale Standard Deviation 25.92
Cough, Urge to Cough, and Fatigue Visual Analogue Scales (VAS) Score During the Peri-Diagnostic Period Baseline (Urge to Cough)	33.3 Scores on a Scale Standard Deviation 25.41	28.6 Scores on a Scale Standard Deviation 21.53	16.4 Scores on a Scale Standard Deviation 17.20	25.8 Scores on a Scale Standard Deviation 21.27
Cough, Urge to Cough, and Fatigue Visual Analogue Scales (VAS) Score During the Peri-Diagnostic Period Pre-diagnosis (Urge to Cough)	37.6 Scores on a Scale Standard Deviation 25.73	23.1 Scores on a Scale Standard Deviation 20.03	13.2 Scores on a Scale Standard Deviation 13.51	30.4 Scores on a Scale Standard Deviation 24.29
Cough, Urge to Cough, and Fatigue Visual Analogue Scales (VAS) Score During the Peri-Diagnostic Period Initial diagnosis (Urge to Cough)	36.4 Scores on a Scale Standard Deviation 29.22	22.9 Scores on a Scale Standard Deviation 19.02	13.7 Scores on a Scale Standard Deviation 19.86	38.5 Scores on a Scale Standard Deviation 47.38
Cough, Urge to Cough, and Fatigue Visual Analogue Scales (VAS) Score During the Peri-Diagnostic Period Post-diagnosis (Urge to Cough)	23.5 Scores on a Scale Standard Deviation 15.79	10.8 Scores on a Scale Standard Deviation 9.00	—	—
Cough, Urge to Cough, and Fatigue Visual Analogue Scales (VAS) Score During the Peri-Diagnostic Period End of Study (Urge to Cough)	33.8 Scores on a Scale Standard Deviation 25.18	24.3 Scores on a Scale Standard Deviation 20.14	16.2 Scores on a Scale Standard Deviation 20.00	36.3 Scores on a Scale Standard Deviation 29.75
Cough, Urge to Cough, and Fatigue Visual Analogue Scales (VAS) Score During the Peri-Diagnostic Period Baseline (Fatigue)	38.4 Scores on a Scale Standard Deviation 27.15	39.4 Scores on a Scale Standard Deviation 24.29	30.0 Scores on a Scale Standard Deviation 31.18	33.2 Scores on a Scale Standard Deviation 26.89
Cough, Urge to Cough, and Fatigue Visual Analogue Scales (VAS) Score During the Peri-Diagnostic Period Pre-diagnosis (Fatigue)	34.1 Scores on a Scale Standard Deviation 27.50	31.0 Scores on a Scale Standard Deviation 22.68	32.5 Scores on a Scale Standard Deviation 26.11	32.0 Scores on a Scale Standard Deviation 28.29
Cough, Urge to Cough, and Fatigue Visual Analogue Scales (VAS) Score During the Peri-Diagnostic Period Initial diagnosis (Fatigue)	37.5 Scores on a Scale Standard Deviation 27.50	35.6 Scores on a Scale Standard Deviation 23.79	31.1 Scores on a Scale Standard Deviation 30.00	17.0 Scores on a Scale Standard Deviation 5.66
Cough, Urge to Cough, and Fatigue Visual Analogue Scales (VAS) Score During the Peri-Diagnostic Period Post-diagnosis (Fatigue)	30.4 Scores on a Scale Standard Deviation 23.24	25.3 Scores on a Scale Standard Deviation 19.48	—	—
Cough, Urge to Cough, and Fatigue Visual Analogue Scales (VAS) Score During the Peri-Diagnostic Period End of Study (Fatigue)	38.3 Scores on a Scale Standard Deviation 26.15	34.6 Scores on a Scale Standard Deviation 23.54	35.5 Scores on a Scale Standard Deviation 32.16	31.5 Scores on a Scale Standard Deviation 24.18

SECONDARY outcome

Timeframe: From inclusion into the study to end of the study (up to 18 months)

Population: Only IPF and non-IPF ILD participants with non-zero declines are included in the analysis.

The correlation of FVC (mL) between home and site spirometry was analyzed by taking into account the individually estimated linear regression models of each participant for home-based FVC measurements and site FVC measurements. This analysis was performed for participants diagnosed with IPF or non-IPF ILD in the peri-diagnosis period. The peri-diagnostic period covered the pre-diagnostic period (from inclusion into the study (enrollment visit), participants were followed for a maximum of 12 months in the pre-diagnostic assessment period) and the post-diagnostic period (from diagnosis to the start of drug treatment within 6 months or a maximum of 6 months if no drug treatment was prescribed).

Outcome measures

Measure	IPF Participants n=57 Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants n=55 Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis Participants without diagnosis
Pearson's Correlation Coefficient of FVC (mL) Between Home and Site Spirometry in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period	-0.06 Pearson's Correlation Coefficients	0.35 Pearson's Correlation Coefficients	—	—

SECONDARY outcome

Timeframe: From inclusion into the study to end of the study (up to 18 months)

Population: Only IPF and non-IPF ILD participants with non-zero declines are included in the analysis.

The measure represents the correlation of distance walked (meter) assessed by physical function capacity at home and the 6MWT at the site in the peri-diagnosis period. The peri-diagnostic period covered the pre-diagnostic period (from inclusion into the study (enrollment visit), participants were followed for a maximum of 12 months in the pre-diagnostic assessment period) and the post-diagnostic period (from diagnosis to the start of drug treatment within 6 months or a maximum of 6 months if no drug treatment was prescribed).

Outcome measures

Measure	IPF Participants n=54 Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants n=52 Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis Participants without diagnosis
Pearson's Correlation Coefficient of Physical Functional Capacity Assessed at Home in Terms of the Decline in the Number of Footsteps and on Site in Terms of the Decline in Distance of the 6MWT	-0.04 Pearson's Correlation Coefficients	0.06 Pearson's Correlation Coefficients	—	—

SECONDARY outcome

Timeframe: From inclusion into the study to end of the study (up to 18 months)

Population: All enrolled participants.

The number of participants requiring the hospitalization were counted during pre- and post-diagnosis period.

Outcome measures

Measure	IPF Participants n=68 Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants n=62 Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants n=9 Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis n=39 Participants Participants without diagnosis
Percentage of Participants Requiring Respiratory-Related Hospitalizations With at least one event during pre-diagnosis period	5.9 Percentage of Participants	4.8 Percentage of Participants	22.2 Percentage of Participants	2.6 Percentage of Participants
Percentage of Participants Requiring Respiratory-Related Hospitalizations With at least one event during post-diagnosis period	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: From inclusion into the study to end of the study (up to 18 months)

Population: All enrolled participants.

The number of participants requiring the hospitalization were counted during pre- and post-diagnosis period. Investigator-reported acute exacerbations, deaths, and events related to study assessments were only collected in the clinical database. As the study had no protocol mandated IMP or treatment requirements, any untoward occurrences such as AEs and SAEs were not collected.

Outcome measures

Measure	IPF Participants n=68 Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants n=62 Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants n=9 Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis n=39 Participants Participants without diagnosis
Percentage of Participants With Non-Elective Hospitalizations With at least one event during pre-diagnosis period	8.8 Percentage of Participants	4.8 Percentage of Participants	22.2 Percentage of Participants	7.7 Percentage of Participants
Percentage of Participants With Non-Elective Hospitalizations With at least one event during post-diagnosis period	2.9 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: From inclusion into the study to end of the study (up to 18 months)

Population: All enrolled participants. Data of post-diagnosis period for non-ILD participants and participants without diagnosis were not collected.

Acute exacerbation was defined as per Collard et al. 2016. Investigator-reported acute exacerbations, deaths, and events related to study assessments were only collected in the clinical database. As the study had no protocol mandated IMP or treatment requirements, any untoward occurrences such as AEs and SAEs were not collected.

Outcome measures

Measure	IPF Participants n=62 Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants n=62 Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants n=9 Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis n=39 Participants Participants without diagnosis
Percentage of Participants With Investigator-Reported Acute Exacerbations With at least one acute exacerbation pre-diagnosis period	1.5 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Investigator-Reported Acute Exacerbations With at least one acute exacerbation during post-diagnosis period	0 Percentage of Participants	0 Percentage of Participants	—	—
Percentage of Participants With Investigator-Reported Acute Exacerbations With at least one triggered acute exacerbation pre-diagnosis period	4.4 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Investigator-Reported Acute Exacerbations With at least one triggered acute exacerbation during post-diagnosis period	0 Percentage of Participants	0 Percentage of Participants	—	—
Percentage of Participants With Investigator-Reported Acute Exacerbations With at least one idiopathic acute exacerbation pre-diagnosis period	0 Percentage of Participants	1.6 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Investigator-Reported Acute Exacerbations With at least one idiopathic acute exacerbation during post-diagnosis period	0 Percentage of Participants	0 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: From inclusion into the study to end of the study (up to 18 months)

Population: All enrolled participants.

The number of participants, who died due to any cause, were counted during pre- and post-diagnosis period.

Outcome measures

Measure	IPF Participants n=68 Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants n=62 Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants n=9 Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis n=39 Participants Participants without diagnosis
Percentage of Participants Who Died Due to Any Cause	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: From inclusion into the study to end of the study (up to 18 months)

Population: All enrolled participants.

The number of participants, who died due to respiratory-related diseases, were counted during pre- and post-diagnosis period.

Outcome measures

Measure	IPF Participants n=68 Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants n=62 Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants n=9 Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis n=39 Participants Participants without diagnosis
Percentage of Participants Who Died Due to Respiratory-Related Diseases	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants

SECONDARY outcome

Timeframe: From inclusion into the study to end of the study (up to 18 months)

Population: All enrolled participants.

The number of participants with events related to the study assessments were counted during pre- and post-diagnosis period. Investigator-reported acute exacerbations, deaths, and events related to study assessments were only collected in the clinical database. As the study had no protocol mandated IMP or treatment requirements, any untoward occurrences such as AEs and SAEs were not collected.

Outcome measures

Measure	IPF Participants n=68 Participants Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)	Non-IPF ILD Participants n=62 Participants Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)	Non-ILD Participants n=9 Participants Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)	Participants Without Diagnosis n=39 Participants Participants without diagnosis
Percentage of Participants With Events Related to the Study Assessments	0 Percentage of Participants	3.2 Percentage of Participants	0 Percentage of Participants	5.1 Percentage of Participants

Adverse Events

IPF Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Participants With and an ILD Other Than IPF (Non-IPF ILD)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-ILD Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Participants Without Diagnosis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER