We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03261037
Recruitment Status : Completed
First Posted : August 24, 2017
Results First Posted : March 26, 2021
Last Update Posted : March 26, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Idiopathic Pulmonary Fibrosis
Interstitial Lung Disease
Interventions Other: Spirometry
Other: Accelerometry
Other: 6MWT
Enrollment 178
Recruitment Details The study enrolled participants in Canada, France, Ireland, Italy, the Netherlands, and Russia.
Pre-assignment Details  
Arm/Group Title IPF Participants Non-IPF ILD Participants Non-ILD Participants Participants Without Diagnosis
Hide Arm/Group Description Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF) Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF) Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD) Participants without diagnosis
Period Title: Overall Study
Started 68 62 9 39
Completed 64 41 9 11
Not Completed 4 21 0 28
Reason Not Completed
Withdrawal by Subject             2             13             0             18
Non-compliance with study procedures             0             2             0             6
Participant moving away and can no longer be in study             0             1             0             0
Participant came out of study due to investigator discretion             0             2             0             0
Diagnosed but protocol deviation             1             0             0             0
Participant did not want to continue the study             0             1             0             0
Participant did not want to continue the diagnostic procedures             0             0             0             1
Participant presented clinical improvement             0             2             0             0
Technical difficulties             0             0             0             1
Equipment failed to work             0             0             0             1
End of study for participant and no follow up             0             0             0             1
Participant was too weak to continue in study             1             0             0             0
Arm/Group Title IPF Participants Non-IPF ILD Participants Non-ILD Participants Participants Without Diagnosis Total
Hide Arm/Group Description Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF) Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF) Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD) Participants without diagnosis Total of all reporting groups
Overall Number of Baseline Participants 68 62 9 39 178
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 68 participants 62 participants 9 participants 39 participants 178 participants
69.3  (6.97) 65.1  (9.99) 69.6  (7.7) 71.2  (8.64) 68.3  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 62 participants 9 participants 39 participants 178 participants
Female
19
  27.9%
32
  51.6%
3
  33.3%
12
  30.8%
66
  37.1%
Male
49
  72.1%
30
  48.4%
6
  66.7%
27
  69.2%
112
  62.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 68 participants 62 participants 9 participants 39 participants 178 participants
American Indian or Alaskan Native 1 0 0 0 1
White 62 50 7 24 143
Unknown 0 1 0 0 1
Missing 5 11 2 15 33
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 68 participants 62 participants 9 participants 39 participants 178 participants
Hispanic or Latino 9 12 0 1 22
Not Hispanic or Latin 49 36 7 20 112
Not reported 4 3 0 2 9
Unknown 1 0 0 1 2
Missing 5 11 2 15 33
1.Primary Outcome
Title 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
Hide Description 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).
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants diagnosed with IPF. Only participants for whom data were collected are included in the analysis.
Arm/Group Title IPF Participants
Hide Arm/Group Description:
Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
Overall Number of Participants Analyzed 64
Mean (Standard Deviation)
Unit of Measure: milliliter (mL)
-308.7  (1268.72)
2.Secondary Outcome
Title Time-Adjusted Semi-Annual FVC Decline in Participants With Non-IPF ILD During the Peri-Diagnostic Period, Measured in mL by Daily Home Spirometry
Hide Description 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).
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants diagnosed with non-IPF ILD. Only participants for whom data were collected are included in the analysis.
Arm/Group Title Non-IPF ILD Participants
Hide Arm/Group Description:
Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: mL
57.5  (1277.03)
3.Secondary Outcome
Title 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
Hide Description 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).
Time Frame From Baseline to end of the study (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants diagnosed with IPF and non-IPF ILD. Only participants for whom data were collected are included in the analysis.
Arm/Group Title IPF Participants Non-IPF ILD Participants
Hide Arm/Group Description:
Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
Overall Number of Participants Analyzed 68 62
Mean (Standard Deviation)
Unit of Measure: mL
Baseline Number Analyzed 66 participants 61 participants
2845.6  (814.83) 2782.4  (870.24)
Change from Baseline at End of Study Visit Number Analyzed 62 participants 59 participants
-51.3  (270.56) -27.1  (265.52)
4.Secondary Outcome
Title Change From Baseline in the Percent Predicted FVC in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured by Site Spirometry
Hide Description 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).
Time Frame From Baseline to end of the study (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants diagnosed with IPF and non-IPF ILD. Only participants for whom data were collected are included in the analysis.
Arm/Group Title IPF Participants Non-IPF ILD Participants
Hide Arm/Group Description:
Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
Overall Number of Participants Analyzed 68 62
Mean (Standard Deviation)
Unit of Measure: Percent Predicted (%)
Baseline Number Analyzed 66 participants 61 participants
82.8  (18.74) 83.9  (17.82)
Change form Baseline at End of Study Visit Number Analyzed 62 participants 59 participants
-0.6  (7.26) -0.6  (8.49)
5.Secondary Outcome
Title 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
Hide Description 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).
Time Frame From Baseline to end of the study (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants diagnosed with IPF and non-IPF ILD. Only participants for whom data were collected are included in the analysis.
Arm/Group Title IPF Participants Non-IPF ILD Participants
Hide Arm/Group Description:
Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
Overall Number of Participants Analyzed 68 62
Mean (Standard Deviation)
Unit of Measure: Meter (m)
Baseline Number Analyzed 66 participants 60 participants
434.6  (117.30) 429.4  (139.51)
Change from Baseline at End of Study Visit Number Analyzed 63 participants 55 participants
4.4  (96.18) 6.4  (87.97)
6.Secondary Outcome
Title Decline in Physical Function Capacity (Steps/Day) in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured by Daily Home Accelerometry
Hide Description 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).
Time Frame From inclusion into the study to end of the study (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants diagnosed with IPF and non-IPF ILD. Only participants for whom data were collected are included in the analysis.
Arm/Group Title IPF Participants Non-IPF ILD Participants
Hide Arm/Group Description:
Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
Overall Number of Participants Analyzed 66 61
Mean (Standard Deviation)
Unit of Measure: Steps per Day
-1237.2  (14146.07) -13407.3  (72612.82)
7.Secondary Outcome
Title Calorie Expenditure in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured by Daily Home Accelerometry
Hide Description [Not Specified]
Time Frame From inclusion into the study to end of the study (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Data collection was impacted by technical problems that could not be solved, thus invalid data collected was not analyzed.
Arm/Group Title IPF Participants Non-IPF ILD Participants
Hide Arm/Group Description:
Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
Overall Number of Participants Analyzed 68 62
Measure Type: Number
Unit of Measure: Calorie
NA [1]  NA [1] 
[1]
Calorie expenditure device was malfunctioning and unreliable data were collected, which was not suitable to analyse therefore there was no analysis done.
8.Secondary Outcome
Title Change in the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Total Score by Visit During the Peri-Diagnostic Period
Hide Description 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).
Time Frame From inclusion into the study to end of the study (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants completed the questionnaire. Only participants for whom data were collected are included in the analysis.
Arm/Group Title IPF Participants Non-IPF ILD Participants Non-ILD Participants Participants Without Diagnosis
Hide Arm/Group Description:
Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)
Participants without diagnosis
Overall Number of Participants Analyzed 68 62 9 39
Mean (Standard Deviation)
Unit of Measure: Units on scale
Baseline Number Analyzed 68 participants 62 participants 9 participants 38 participants
60.57  (17.633) 55.70  (14.203) 54.22  (11.703) 60.47  (15.728)
Change from Baseline at End of Study Visit Number Analyzed 63 participants 60 participants 9 participants 24 participants
-0.45  (9.709) 3.98  (11.851) 6.03  (14.294) 4.01  (9.313)
9.Secondary Outcome
Title Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period
Hide Description 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).
Time Frame From inclusion into the study to end of the study (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title IPF Participants Non-IPF ILD Participants Non-ILD Participants Participants Without Diagnosis
Hide Arm/Group Description:
Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)
Participants without diagnosis
Overall Number of Participants Analyzed 68 61 9 32
Measure Type: Count of Participants
Unit of Measure: Participants
Pre-diagnosis Number Analyzed 30 participants 29 participants 7 participants 20 participants
Grade 0
12
  40.0%
10
  34.5%
2
  28.6%
6
  30.0%
Grade 1
8
  26.7%
8
  27.6%
1
  14.3%
11
  55.0%
Grade 2
7
  23.3%
9
  31.0%
3
  42.9%
2
  10.0%
Grade 3
3
  10.0%
2
   6.9%
1
  14.3%
1
   5.0%
Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Initial diagnosis Number Analyzed 68 participants 61 participants 8 participants 3 participants
Grade 0
22
  32.4%
17
  27.9%
3
  37.5%
2
  66.7%
Grade 1
31
  45.6%
25
  41.0%
0
   0.0%
0
   0.0%
Grade 2
10
  14.7%
16
  26.2%
3
  37.5%
1
  33.3%
Grade 3
5
   7.4%
3
   4.9%
2
  25.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Post-diagnosis Number Analyzed 6 participants 3 participants 0 participants 0 participants
Grade 0
2
  33.3%
1
  33.3%
Grade 1
4
  66.7%
2
  66.7%
Grade 2
0
   0.0%
0
   0.0%
Grade 3
0
   0.0%
0
   0.0%
Grade 4
0
   0.0%
0
   0.0%
End of Study Number Analyzed 65 participants 61 participants 9 participants 32 participants
Grade 0
20
  30.8%
17
  27.9%
3
  33.3%
13
  40.6%
Grade 1
30
  46.2%
25
  41.0%
1
  11.1%
15
  46.9%
Grade 2
10
  15.4%
16
  26.2%
3
  33.3%
3
   9.4%
Grade 3
5
   7.7%
3
   4.9%
2
  22.2%
1
   3.1%
Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period
Hide Description 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).
Time Frame From inclusion into the study to end of the study (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title IPF Participants Non-IPF ILD Participants Non-ILD Participants Participants Without Diagnosis
Hide Arm/Group Description:
Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)
Participants without diagnosis
Overall Number of Participants Analyzed 68 62 9 38
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Mobility Number Analyzed 68 participants 62 participants 9 participants 38 participants
Level 1
33
  48.5%
25
  40.3%
2
  22.2%
24
  63.2%
Level 2
16
  23.5%
15
  24.2%
2
  22.2%
9
  23.7%
Level 3
14
  20.6%
21
  33.9%
5
  55.6%
4
  10.5%
Level 4
5
   7.4%
1
   1.6%
0
   0.0%
1
   2.6%
Level 5
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Self-care Number Analyzed 68 participants 62 participants 9 participants 38 participants
Level 1
55
  80.9%
52
  83.9%
6
  66.7%
34
  89.5%
Level 2
7
  10.3%
6
   9.7%
2
  22.2%
4
  10.5%
Level 3
6
   8.8%
4
   6.5%
1
  11.1%
0
   0.0%
Level 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Level 5
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Usual activities Number Analyzed 68 participants 62 participants 9 participants 38 participants
Level 1
32
  47.1%
29
  46.8%
4
  44.4%
20
  52.6%
Level 2
19
  27.9%
16
  25.8%
2
  22.2%
10
  26.3%
Level 3
16
  23.5%
15
  24.2%
2
  22.2%
4
  10.5%
Level 4
1
   1.5%
2
   3.2%
0
   0.0%
4
  10.5%
Level 5
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Pain/Discomfort Number Analyzed 68 participants 62 participants 9 participants 38 participants
Level 1
29
  42.6%
25
  40.3%
3
  33.3%
20
  52.6%
Level 2
22
  32.4%
22
  35.5%
2
  22.2%
10
  26.3%
Level 3
17
  25.0%
14
  22.6%
3
  33.3%
4
  10.5%
Level 4
0
   0.0%
1
   1.6%
1
  11.1%
3
   7.9%
Level 5
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.6%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Anxiety/Depression Number Analyzed 68 participants 62 participants 9 participants 38 participants
Level 1
38
  55.9%
24
  38.7%
5
  55.6%
19
  50.0%
Level 2
22
  32.4%
20
  32.3%
2
  22.2%
12
  31.6%
Level 3
5
   7.4%
15
  24.2%
2
  22.2%
7
  18.4%
Level 4
2
   2.9%
2
   3.2%
0
   0.0%
0
   0.0%
Level 5
1
   1.5%
1
   1.6%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Pre-diagnosis Mobility Number Analyzed 30 participants 29 participants 7 participants 21 participants
Level 1
16
  53.3%
11
  37.9%
1
  14.3%
13
  61.9%
Level 2
4
  13.3%
9
  31.0%
2
  28.6%
4
  19.0%
Level 3
9
  30.0%
5
  17.2%
2
  28.6%
1
   4.8%
Level 4
1
   3.3%
3
  10.3%
2
  28.6%
2
   9.5%
Level 5
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   3.4%
0
   0.0%
1
   4.8%
Pre-diagnosis Self-care Number Analyzed 30 participants 29 participants 7 participants 21 participants
Level 1
25
  83.3%
25
  86.2%
5
  71.4%
20
  95.2%
Level 2
3
  10.0%
2
   6.9%
2
  28.6%
0
   0.0%
Level 3
1
   3.3%
1
   3.4%
0
   0.0%
0
   0.0%
Level 4
1
   3.3%
0
   0.0%
0
   0.0%
0
   0.0%
Level 5
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
0
   0.0%
1
   3.4%
0
   0.0%
1
   4.8%
Pre-diagnosis Usual activities Number Analyzed 30 participants 29 participants 7 participants 21 participants
Level 1
15
  50.0%
15
  51.7%
2
  28.6%
9
  42.9%
Level 2
10
  33.3%
6
  20.7%
3
  42.9%
6
  28.6%
Level 3
4
  13.3%
7
  24.1%
2
  28.6%
4
  19.0%
Level 4
1
   3.3%
0
   0.0%
0
   0.0%
0
   0.0%
Level 5
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.8%
Missing
0
   0.0%
1
   3.4%
0
   0.0%
1
   4.8%
Pre-diagnosis Pain/Discomfort Number Analyzed 30 participants 29 participants 7 participants 21 participants
Level 1
15
  50.0%
15
  51.7%
1
  14.3%
12
  57.1%
Level 2
11
  36.7%
7
  24.1%
4
  57.1%
3
  14.3%
Level 3
3
  10.0%
5
  17.2%
0
   0.0%
4
  19.0%
Level 4
1
   3.3%
1
   3.4%
2
  28.6%
0
   0.0%
Level 5
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.8%
Missing
0
   0.0%
1
   3.4%
0
   0.0%
1
   4.8%
Pre-diagnosis Anxiety/Depression Number Analyzed 30 participants 29 participants 7 participants 21 participants
Level 1
14
  46.7%
12
  41.4%
2
  28.6%
10
  47.6%
Level 2
11
  36.7%
10
  34.5%
4
  57.1%
8
  38.1%
Level 3
3
  10.0%
6
  20.7%
1
  14.3%
1
   4.8%
Level 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Level 5
2
   6.7%
0
   0.0%
0
   0.0%
1
   4.8%
Missing
0
   0.0%
1
   3.4%
0
   0.0%
1
   4.8%
Initial diagnosis Mobility Number Analyzed 68 participants 62 participants 8 participants 3 participants
Level 1
31
  45.6%
26
  41.9%
2
  25.0%
2
  66.7%
Level 2
19
  27.9%
17
  27.4%
3
  37.5%
0
   0.0%
Level 3
12
  17.6%
9
  14.5%
2
  25.0%
0
   0.0%
Level 4
3
   4.4%
6
   9.7%
1
  12.5%
0
   0.0%
Level 5
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
3
   4.4%
4
   6.5%
0
   0.0%
1
  33.3%
Initial diagnosis Self-care Number Analyzed 68 participants 62 participants 8 participants 3 participants
Level 1
55
  80.9%
44
  71.0%
6
  75.0%
2
  66.7%
Level 2
3
   4.4%
10
  16.1%
1
  12.5%
0
   0.0%
Level 3
6
   8.8%
4
   6.5%
1
  12.5%
0
   0.0%
Level 4
1
   1.5%
0
   0.0%
0
   0.0%
0
   0.0%
Level 5
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
3
   4.4%
4
   6.5%
0
   0.0%
1
  33.3%
Initial diagnosis Usual activities Number Analyzed 68 participants 62 participants 8 participants 3 participants
Level 1
31
  45.6%
27
  43.5%
6
  75.0%
2
  66.7%
Level 2
20
  29.4%
14
  22.6%
1
  12.5%
0
   0.0%
Level 3
9
  13.2%
14
  22.6%
1
  12.5%
0
   0.0%
Level 4
4
   5.9%
3
   4.8%
0
   0.0%
0
   0.0%
Level 5
1
   1.5%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
3
   4.4%
4
   6.5%
0
   0.0%
1
  33.3%
Initial diagnosis Pain/Discomfort Number Analyzed 68 participants 62 participants 8 participants 3 participants
Level 1
32
  47.1%
34
  54.8%
2
  25.0%
1
  33.3%
Level 2
22
  32.4%
14
  22.6%
1
  12.5%
1
  33.3%
Level 3
10
  14.7%
6
   9.7%
3
  37.5%
0
   0.0%
Level 4
1
   1.5%
4
   6.5%
2
  25.0%
0
   0.0%
Level 5
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
3
   4.4%
4
   6.5%
0
   0.0%
1
  33.3%
Initial diagnosis Anxiety/Depression Number Analyzed 68 participants 62 participants 8 participants 3 participants
Level 1
30
  44.1%
25
  40.3%
4
  50.0%
1
  33.3%
Level 2
21
  30.9%
17
  27.4%
1
  12.5%
1
  33.3%
Level 3
10
  14.7%
13
  21.0%
1
  12.5%
0
   0.0%
Level 4
2
   2.9%
3
   4.8%
2
  25.0%
0
   0.0%
Level 5
2
   2.9%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
3
   4.4%
4
   6.5%
0
   0.0%
1
  33.3%
Post-diagnosis Mobility Number Analyzed 6 participants 3 participants 0 participants 0 participants
Level 1
2
  33.3%
0
   0.0%
Level 2
1
  16.7%
2
  66.7%
Level 3
2
  33.3%
1
  33.3%
Level 4
0
   0.0%
0
   0.0%
Level 5
0
   0.0%
0
   0.0%
Missing
1
  16.7%
0
   0.0%
Post-diagnosis Self-care Number Analyzed 6 participants 3 participants 0 participants 0 participants
Level 1
4
  66.7%
2
  66.7%
Level 2
0
   0.0%
1
  33.3%
Level 3
1
  16.7%
0
   0.0%
Level 4
0
   0.0%
0
   0.0%
Level 5
0
   0.0%
0
   0.0%
Missing
1
  16.7%
0
   0.0%
Post-diagnosis Usual activities Number Analyzed 6 participants 3 participants 0 participants 0 participants
Level 1
2
  33.3%
2
  66.7%
Level 2
2
  33.3%
0
   0.0%
Level 3
1
  16.7%
1
  33.3%
Level 4
0
   0.0%
0
   0.0%
Level 5
0
   0.0%
0
   0.0%
Missing
1
  16.7%
0
   0.0%
Post-diagnosis Pain/Discomfort Number Analyzed 6 participants 3 participants 0 participants 0 participants
Level 1
1
  16.7%
2
  66.7%
Level 2
4
  66.7%
0
   0.0%
Level 3
0
   0.0%
1
  33.3%
Level 4
0
   0.0%
0
   0.0%
Level 5
0
   0.0%
0
   0.0%
Missing
1
  16.7%
0
   0.0%
Post-diagnosis Anxiety/Depression Number Analyzed 6 participants 3 participants 0 participants 0 participants
Level 1
3
  50.0%
0
   0.0%
Level 2
1
  16.7%
2
  66.7%
Level 3
1
  16.7%
1
  33.3%
Level 4
0
   0.0%
0
   0.0%
Level 5
0
   0.0%
0
   0.0%
Missing
1
  16.7%
0
   0.0%
End of Study Mobility Number Analyzed 65 participants 62 participants 9 participants 33 participants
Level 1
33
  50.8%
28
  45.2%
2
  22.2%
16
  48.5%
Level 2
15
  23.1%
15
  24.2%
3
  33.3%
2
   6.1%
Level 3
11
  16.9%
14
  22.6%
3
  33.3%
4
  12.1%
Level 4
4
   6.2%
3
   4.8%
1
  11.1%
2
   6.1%
Level 5
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
2
   3.1%
2
   3.2%
0
   0.0%
9
  27.3%
End of Study Self-care Number Analyzed 65 participants 62 participants 9 participants 33 participants
Level 1
54
  83.1%
46
  74.2%
6
  66.7%
22
  66.7%
Level 2
3
   4.6%
12
  19.4%
2
  22.2%
1
   3.0%
Level 3
5
   7.7%
2
   3.2%
1
  11.1%
1
   3.0%
Level 4
1
   1.5%
0
   0.0%
0
   0.0%
0
   0.0%
Level 5
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
2
   3.1%
2
   3.2%
0
   0.0%
9
  27.3%
End of Study Usual activities Number Analyzed 65 participants 62 participants 9 participants 33 participants
Level 1
32
  49.2%
25
  40.3%
4
  44.4%
14
  42.4%
Level 2
16
  24.6%
18
  29.0%
0
   0.0%
5
  15.2%
Level 3
11
  16.9%
15
  24.2%
4
  44.4%
4
  12.1%
Level 4
3
   4.6%
2
   3.2%
1
  11.1%
1
   3.0%
Level 5
1
   1.5%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
2
   3.1%
2
   3.2%
0
   0.0%
9
  27.3%
End of Study Pain/Discomfort Number Analyzed 65 participants 62 participants 9 participants 33 participants
Level 1
30
  46.2%
34
  54.8%
2
  22.2%
14
  42.4%
Level 2
20
  30.8%
16
  25.8%
1
  11.1%
3
   9.1%
Level 3
13
  20.0%
8
  12.9%
4
  44.4%
6
  18.2%
Level 4
0
   0.0%
2
   3.2%
2
  22.2%
1
   3.0%
Level 5
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
2
   3.1%
2
   3.2%
0
   0.0%
9
  27.3%
End of Study Anxiety/Depression Number Analyzed 65 participants 62 participants 9 participants 33 participants
Level 1
28
  43.1%
25
  40.3%
4
  44.4%
13
  39.4%
Level 2
21
  32.3%
19
  30.6%
1
  11.1%
10
  30.3%
Level 3
10
  15.4%
15
  24.2%
2
  22.2%
0
   0.0%
Level 4
2
   3.1%
1
   1.6%
2
  22.2%
1
   3.0%
Level 5
2
   3.1%
0
   0.0%
0
   0.0%
0
   0.0%
Missing
2
   3.1%
2
   3.2%
0
   0.0%
9
  27.3%
11.Secondary Outcome
Title The EuroQol Visual Analogue Scale (EQ-VAS) Health State Profile Scores During the Peri-Diagnostic Period During the Peri-Diagnostic Period
Hide Description 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).
Time Frame From inclusion into the study to end of the study (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title IPF Participants Non-IPF ILD Participants Non-ILD Participants Participants Without Diagnosis
Hide Arm/Group Description:
Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)
Participants without diagnosis
Overall Number of Participants Analyzed 68 62 9 39
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Health State Index Baseline Number Analyzed 68 participants 61 participants 9 participants 38 participants
71.7  (15.96) 67.4  (20.11) 68.9  (17.99) 76.2  (17.09)
Health State Index Pre-diagnosis Number Analyzed 30 participants 28 participants 7 participants 20 participants
69.8  (15.50) 71.5  (15.89) 65.7  (19.88) 73.5  (16.06)
Health State Index Initial diagnosis Number Analyzed 65 participants 58 participants 8 participants 2 participants
69.5  (16.23) 68.3  (18.03) 70.4  (19.92) 72.5  (10.61)
Health State Index Post-diagnosis Number Analyzed 5 participants 3 participants 0 participants 0 participants
69.0  (25.10) 76.7  (12.58)
Health State Index End of Study Number Analyzed 63 participants 60 participants 9 participants 24 participants
69.5  (16.46) 69.8  (17.21) 67.0  (21.21) 74.2  (16.85)
12.Secondary Outcome
Title The EuroQoL 5-dimension 5-level Questionnaire Index Utility Scores During the Peri-Diagnostic Period
Hide Description 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.
Time Frame From inclusion into the study to end of the study (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title IPF Participants Non-IPF ILD Participants Non-ILD Participants Participants Without Diagnosis
Hide Arm/Group Description:
Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)
Participants without diagnosis
Overall Number of Participants Analyzed 68 62 9 39
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Index utility score Baseline Number Analyzed 68 participants 62 participants 9 participants 38 participants
0.83  (0.140) 0.79  (0.143) 0.67  (0.250) 0.80  (0.187)
Index utility score Pre-diagnosis Number Analyzed 30 participants 28 participants 7 participants 20 participants
0.82  (0.154) 0.80  (0.152) 0.68  (0.237) 0.83  (0.182)
Index utility score Initial diagnosis Number Analyzed 65 participants 58 participants 8 participants 2 participants
0.81  (0.162) 0.78  (0.197) 0.63  (0.331) 0.92  (0.013)
Index utility score Post-diagnosis Number Analyzed 5 participants 3 participants 0 participants 0 participants
0.81  (0.149) 0.75  (0.123)
Index utility score End of Study Number Analyzed 63 participants 60 participants 9 participants 24 participants
0.81  (0.164) 0.80  (0.164) 0.62  (0.312) 0.81  (0.197)
13.Secondary Outcome
Title Fatigue Assessment Scale (FAS) Score During the Peri-Diagnostic Period
Hide Description 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).
Time Frame From inclusion into the study to end of the study (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title IPF Participants Non-IPF ILD Participants Non-ILD Participants Participants Without Diagnosis
Hide Arm/Group Description:
Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)
Participants without diagnosis
Overall Number of Participants Analyzed 68 62 9 39
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline Number Analyzed 67 participants 60 participants 9 participants 37 participants
21.8  (6.44) 21.8  (6.89) 21.1  (7.22) 20.9  (6.99)
Initial diagnosis Number Analyzed 64 participants 56 participants 7 participants 2 participants
21.7  (6.66) 22.6  (7.33) 24.7  (9.11) 18.0  (2.83)
End of study Number Analyzed 63 participants 58 participants 8 participants 24 participants
22.0  (6.17) 22.0  (7.59) 26.1  (9.33) 20.6  (6.31)
14.Secondary Outcome
Title Cough, Urge to Cough, and Fatigue Visual Analogue Scales (VAS) Score During the Peri-Diagnostic Period
Hide Description 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).
Time Frame From inclusion into the study to end of the study (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title IPF Participants Non-IPF ILD Participants Non-ILD Participants Participants Without Diagnosis
Hide Arm/Group Description:
Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)
Participants without diagnosis
Overall Number of Participants Analyzed 68 62 9 39
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline (Cough) Number Analyzed 68 participants 60 participants 9 participants 38 participants
34.0  (25.44) 26.9  (20.66) 17.9  (21.99) 27.4  (20.38)
Pre-diagnosis (Cough) Number Analyzed 30 participants 28 participants 7 participants 20 participants
36.8  (25.50) 25.4  (20.90) 11.4  (14.03) 31.4  (24.34)
Initial diagnosis (Cough) Number Analyzed 65 participants 58 participants 8 participants 2 participants
36.3  (29.60) 21.9  (18.88) 17.1  (21.69) 32.0  (36.77)
Post-diagnosis (Cough) Number Analyzed 5 participants 3 participants 0 participants 0 participants
25.6  (20.94) 17.0  (9.16)
End of Study (Cough) Number Analyzed 63 participants 60 participants 9 participants 24 participants
34.7  (26.64) 24.0  (19.42) 19.3  (21.35) 31.2  (25.92)
Baseline (Urge to Cough) Number Analyzed 68 participants 60 participants 9 participants 38 participants
33.3  (25.41) 28.6  (21.53) 16.4  (17.20) 25.8  (21.27)
Pre-diagnosis (Urge to Cough) Number Analyzed 30 participants 28 participants 7 participants 19 participants
37.6  (25.73) 23.1  (20.03) 13.2  (13.51) 30.4  (24.29)
Initial diagnosis (Urge to Cough) Number Analyzed 65 participants 58 participants 8 participants 2 participants
36.4  (29.22) 22.9  (19.02) 13.7  (19.86) 38.5  (47.38)
Post-diagnosis (Urge to Cough) Number Analyzed 5 participants 3 participants 0 participants 0 participants
23.5  (15.79) 10.8  (9.00)
End of Study (Urge to Cough) Number Analyzed 63 participants 60 participants 9 participants 23 participants
33.8  (25.18) 24.3  (20.14) 16.2  (20.00) 36.3  (29.75)
Baseline (Fatigue) Number Analyzed 68 participants 60 participants 9 participants 38 participants
38.4  (27.15) 39.4  (24.29) 30.0  (31.18) 33.2  (26.89)
Pre-diagnosis (Fatigue) Number Analyzed 30 participants 28 participants 7 participants 20 participants
34.1  (27.50) 31.0  (22.68) 32.5  (26.11) 32.0  (28.29)
Initial diagnosis (Fatigue) Number Analyzed 65 participants 58 participants 8 participants 2 participants
37.5  (27.50) 35.6  (23.79) 31.1  (30.00) 17.0  (5.66)
Post-diagnosis (Fatigue) Number Analyzed 5 participants 3 participants 0 participants 0 participants
30.4  (23.24) 25.3  (19.48)
End of Study (Fatigue) Number Analyzed 63 participants 60 participants 9 participants 24 participants
38.3  (26.15) 34.6  (23.54) 35.5  (32.16) 31.5  (24.18)
15.Secondary Outcome
Title Pearson's Correlation Coefficient of FVC (mL) Between Home and Site Spirometry in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period
Hide Description 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).
Time Frame From inclusion into the study to end of the study (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Only IPF and non-IPF ILD participants with non-zero declines are included in the analysis.
Arm/Group Title IPF Participants Non-IPF ILD Participants
Hide Arm/Group Description:
Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
Overall Number of Participants Analyzed 57 55
Measure Type: Number
Unit of Measure: Pearson's Correlation Coefficients
-0.06 0.35
16.Secondary Outcome
Title 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
Hide Description 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).
Time Frame From inclusion into the study to end of the study (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Only IPF and non-IPF ILD participants with non-zero declines are included in the analysis.
Arm/Group Title IPF Participants Non-IPF ILD Participants
Hide Arm/Group Description:
Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
Overall Number of Participants Analyzed 54 52
Measure Type: Number
Unit of Measure: Pearson's Correlation Coefficients
-0.04 0.06
17.Secondary Outcome
Title Percentage of Participants Requiring Respiratory-Related Hospitalizations
Hide Description The number of participants requiring the hospitalization were counted during pre- and post-diagnosis period.
Time Frame From inclusion into the study to end of the study (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title IPF Participants Non-IPF ILD Participants Non-ILD Participants Participants Without Diagnosis
Hide Arm/Group Description:
Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)
Participants without diagnosis
Overall Number of Participants Analyzed 68 62 9 39
Measure Type: Number
Unit of Measure: Percentage of Participants
With at least one event during pre-diagnosis period 5.9 4.8 22.2 2.6
With at least one event during post-diagnosis period 0 0 0 0
18.Secondary Outcome
Title Percentage of Participants With Non-Elective Hospitalizations
Hide Description 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.
Time Frame From inclusion into the study to end of the study (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title IPF Participants Non-IPF ILD Participants Non-ILD Participants Participants Without Diagnosis
Hide Arm/Group Description:
Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)
Participants without diagnosis
Overall Number of Participants Analyzed 68 62 9 39
Measure Type: Number
Unit of Measure: Percentage of Participants
With at least one event during pre-diagnosis period 8.8 4.8 22.2 7.7
With at least one event during post-diagnosis period 2.9 0 0 0
19.Secondary Outcome
Title Percentage of Participants With Investigator-Reported Acute Exacerbations
Hide Description 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.
Time Frame From inclusion into the study to end of the study (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants. Data of post-diagnosis period for non-ILD participants and participants without diagnosis were not collected.
Arm/Group Title IPF Participants Non-IPF ILD Participants Non-ILD Participants Participants Without Diagnosis
Hide Arm/Group Description:
Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)
Participants without diagnosis
Overall Number of Participants Analyzed 62 62 9 39
Measure Type: Number
Unit of Measure: Percentage of Participants
With at least one acute exacerbation pre-diagnosis period Number Analyzed 62 participants 62 participants 9 participants 39 participants
1.5 0 0 0
With at least one acute exacerbation during post-diagnosis period Number Analyzed 62 participants 62 participants 0 participants 0 participants
0 0
With at least one triggered acute exacerbation pre-diagnosis period Number Analyzed 62 participants 62 participants 9 participants 39 participants
4.4 0 0 0
With at least one triggered acute exacerbation during post-diagnosis period Number Analyzed 62 participants 62 participants 0 participants 0 participants
0 0
With at least one idiopathic acute exacerbation pre-diagnosis period Number Analyzed 62 participants 62 participants 9 participants 39 participants
0 1.6 0 0
With at least one idiopathic acute exacerbation during post-diagnosis period Number Analyzed 62 participants 62 participants 0 participants 0 participants
0 0
20.Secondary Outcome
Title Percentage of Participants Who Died Due to Any Cause
Hide Description The number of participants, who died due to any cause, were counted during pre- and post-diagnosis period.
Time Frame From inclusion into the study to end of the study (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title IPF Participants Non-IPF ILD Participants Non-ILD Participants Participants Without Diagnosis
Hide Arm/Group Description:
Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)
Participants without diagnosis
Overall Number of Participants Analyzed 68 62 9 39
Measure Type: Number
Unit of Measure: Percentage of Participants
0 0 0 0
21.Secondary Outcome
Title Percentage of Participants Who Died Due to Respiratory-Related Diseases
Hide Description The number of participants, who died due to respiratory-related diseases, were counted during pre- and post-diagnosis period.
Time Frame From inclusion into the study to end of the study (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title IPF Participants Non-IPF ILD Participants Non-ILD Participants Participants Without Diagnosis
Hide Arm/Group Description:
Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)
Participants without diagnosis
Overall Number of Participants Analyzed 68 62 9 39
Measure Type: Number
Unit of Measure: Percentage of Participants
0 0 0 0
22.Secondary Outcome
Title Percentage of Participants With Events Related to the Study Assessments
Hide Description 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.
Time Frame From inclusion into the study to end of the study (up to 18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants.
Arm/Group Title IPF Participants Non-IPF ILD Participants Non-ILD Participants Participants Without Diagnosis
Hide Arm/Group Description:
Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF)
Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF)
Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD)
Participants without diagnosis
Overall Number of Participants Analyzed 68 62 9 39
Measure Type: Number
Unit of Measure: Percentage of Participants
0 3.2 0 5.1
Time Frame From inclusion into the study to end of the study (up to 18 months)
Adverse Event Reporting Description The study had no protocol mandated IMP or treatment requirements. Participants stopped the study prior to starting any drug treatment for IPF/ILD. Any untoward occurrences thought to be due to or associated with a commercial medicinal product used during the course of a participant's standard medical treatment were not reported in the clinical database, but should have been reported to the respective Market Authorization Holder/ local Health Authority according to local regulatory requirements.
 
Arm/Group Title IPF Participants Participants With and an ILD Other Than IPF (Non-IPF ILD) Non-ILD Participants Participants Without Diagnosis
Hide Arm/Group Description Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF) Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF) Participants diagnosed with a condition that was not an Interstitial Lung Disease (non-ILD) Participants without diagnosis
All-Cause Mortality
IPF Participants Participants With and an ILD Other Than IPF (Non-IPF ILD) Non-ILD Participants Participants Without Diagnosis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/68 (0.00%)   0/62 (0.00%)   0/9 (0.00%)   0/39 (0.00%) 
Hide Serious Adverse Events
IPF Participants Participants With and an ILD Other Than IPF (Non-IPF ILD) Non-ILD Participants Participants Without Diagnosis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IPF Participants Participants With and an ILD Other Than IPF (Non-IPF ILD) Non-ILD Participants Participants Without Diagnosis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03261037    
Other Study ID Numbers: MA39297
2016-005114-22 ( EudraCT Number )
First Submitted: August 22, 2017
First Posted: August 24, 2017
Results First Submitted: November 13, 2020
Results First Posted: March 26, 2021
Last Update Posted: March 26, 2021