A Study to Characterize the Disease Behavior of Idiopathic Pulmonary Fibrosis (IPF) and Interstitial Lung Disease (ILD) During the Peri-Diagnostic Period
Study Details
Study Description
Brief Summary
This international clinical study will enroll participants with a suspected diagnosis of IPF/ILD. This study will characterize the disease behavior of IPF and ILD in the peri-diagnostic period. This objective will be achieved using a multidimensional approach assessing changes in pulmonary function, measured by daily handheld spirometry and site spirometry as well as assessing physical functional capacity at home (accelerometry) and at site (6-minute walk tests [6MWT]). Daily handheld spirometry or physical functional capacity assessments are not routinely performed in this participant population. By following participants' lung function before and after diagnosis using home spirometry, levels of physical activity, as well as self-assessment data from the participants (patient reported outcomes; PRO), the study would provide potentially more rapid information on disease behavior and eventually progression compared to usual clinic measurements that occur only every 3-6 months. By receiving data from daily handheld spirometry measurements, treating physicians may have an improved chance of detecting earlier and outside of hospital visits a decline in lung function that could potentially lead to improvements in both diagnosis and treatment for participants with IPF/ILD.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Participants With Suspicion of IPF/ILD A participant will be eligible for inclusion if the Investigator has a suspicion that the participant may have IPF/ILD based on symptoms and radiological evidence. |
Other: Spirometry
Daily spirometry will be conducted by the participant at home using the study kit provided. Spirometry assessments (FVC) will be conducted at approximately the same time each day with the participant in a seated position. Additionally, site spirometry will also be performed during pre-diagnosis assessment period, on the day of diagnosis, post-diagnosis assessment period, and at end of study.
Other: Accelerometry
Daily physical functional capacity assessments (e.g., steps per day, calorie expenditure) will be measured on an ongoing basis using the accelerometry device provided.
Other: 6MWT
The 6MWT will be performed only at sites where a formalized process is available and the test can be performed under safe conditions, during pre-diagnosis assessment period, on the day of diagnosis, post-diagnosis assessment period, and at end of study.
|
Outcome Measures
Primary Outcome Measures
- 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 [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]
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).
Secondary Outcome Measures
- Time-Adjusted Semi-Annual FVC Decline in Participants With Non-IPF ILD During the Peri-Diagnostic Period, Measured in mL by Daily Home Spirometry [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]
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).
- 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 [From Baseline to end of the study (up to 18 months)]
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).
- Change From Baseline in the Percent Predicted FVC in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured by Site Spirometry [From Baseline to end of the study (up to 18 months)]
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).
- 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 [From Baseline to end of the study (up to 18 months)]
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).
- Decline in Physical Function Capacity (Steps/Day) in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured by Daily Home Accelerometry [From inclusion into the study to end of the study (up to 18 months)]
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).
- Calorie Expenditure in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured by Daily Home Accelerometry [From inclusion into the study to end of the study (up to 18 months)]
- Change in the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Total Score by Visit During the Peri-Diagnostic Period [From inclusion into the study to end of the study (up to 18 months)]
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).
- Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period [From inclusion into the study to end of the study (up to 18 months)]
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).
- The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period [From inclusion into the study to end of the study (up to 18 months)]
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).
- The EuroQol Visual Analogue Scale (EQ-VAS) Health State Profile Scores During the Peri-Diagnostic Period During the Peri-Diagnostic Period [From inclusion into the study to end of the study (up to 18 months)]
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).
- The EuroQoL 5-dimension 5-level Questionnaire Index Utility Scores During the Peri-Diagnostic Period [From inclusion into the study to end of the study (up to 18 months)]
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.
- Fatigue Assessment Scale (FAS) Score During the Peri-Diagnostic Period [From inclusion into the study to end of the study (up to 18 months)]
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).
- Cough, Urge to Cough, and Fatigue Visual Analogue Scales (VAS) Score During the Peri-Diagnostic Period [From inclusion into the study to end of the study (up to 18 months)]
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).
- Pearson's Correlation Coefficient of FVC (mL) Between Home and Site Spirometry in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period [From inclusion into the study to end of the study (up to 18 months)]
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).
- 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 [From inclusion into the study to end of the study (up to 18 months)]
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).
- Percentage of Participants Requiring Respiratory-Related Hospitalizations [From inclusion into the study to end of the study (up to 18 months)]
The number of participants requiring the hospitalization were counted during pre- and post-diagnosis period.
- Percentage of Participants With Non-Elective Hospitalizations [From inclusion into the study to end of the study (up to 18 months)]
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.
- Percentage of Participants With Investigator-Reported Acute Exacerbations [From inclusion into the study to end of the study (up to 18 months)]
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.
- Percentage of Participants Who Died Due to Any Cause [From inclusion into the study to end of the study (up to 18 months)]
The number of participants, who died due to any cause, were counted during pre- and post-diagnosis period.
- Percentage of Participants Who Died Due to Respiratory-Related Diseases [From inclusion into the study to end of the study (up to 18 months)]
The number of participants, who died due to respiratory-related diseases, were counted during pre- and post-diagnosis period.
- Percentage of Participants With Events Related to the Study Assessments [From inclusion into the study to end of the study (up to 18 months)]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Able to comply with the study protocol, in the Investigator's judgment - for example, the ability to use the provided spirometer and tablet and the ability to fill in the required patient reported outcomes questionnaires
-
Suspicion of IPF/ILD: radiological evidence of IPF/ILD in symptomatic participants (unexplained dyspnea on exertion and/or cough)
Exclusion Criteria:
-
Participation in any investigational study within 28 days prior to inclusion
-
History of clinically significant cardiac disease that could explain the patient's symptomatology in the opinion of the Investigator
-
Known history of any connective tissue disease, including, but not limited to, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, or mixed connective tissue disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Clare'S Mercy Hospital | St. John's | Newfoundland and Labrador | Canada | A1B 3V6 |
| 2 | Kingston Health Sciences Centre; research Kingston General Health Research Institute | Kingston | Ontario | Canada | K7L 5G2 |
| 3 | Dr. Syed Anees Medicine Profession Corporation | Windsor | Ontario | Canada | N8X 1T3 |
| 4 | Clinique de pneumologie et du sommeil de Lanaudiere | Saint-Charles-Borromee | Quebec | Canada | J6E 2B4 |
| 5 | Hopital Louis Pradel; Pneumologie | Bron | France | 69677 | |
| 6 | Hopital Cote De Nacre; Pneumologie | Caen | France | 14000 | |
| 7 | Ch De Granville; Pneumologie | Granville | France | 50406 | |
| 8 | Hopital Calmette; Pneumologie | Lille | France | 59037 | |
| 9 | Hopital Arnaud De Villeneuve; Pneumologie A | Montpellier | France | 34295 | |
| 10 | Hopital Tenon;Pneumologie | Paris | France | 75970 | |
| 11 | Centre Pneumologie Et Allergie | Perpignan | France | 66025 | |
| 12 | Hopital de Pontchaillou; Service de Pneumologie | Rennes | France | 35033 | |
| 13 | Ch Bretagne Atlantique; Pneumologie-Oncologie | Vannes | France | 56017 | |
| 14 | Cork University Hospital | Cork | Ireland | ||
| 15 | St James's Hospital | Dublin | Ireland | 8 | |
| 16 | P.O. Clinicizz. 'SS. Annunziata'; U.O.C. Pneumologia | Chieti | Abruzzo | Italy | 66100 |
| 17 | Azienda Ospedaliera dei Colli - P. Monaldi; Dip. Medicina Clinica e Chirurgia | Napoli | Campania | Italy | 80131 |
| 18 | A.O. Universitaria Policlinico Di Modena; DIP. Malattie Dell'apparato Respiratorio | Modena | Emilia-Romagna | Italy | 41124 |
| 19 | Policlinico A. Gemelli e C.I.C.; Polo Scienze Cardiovascolari e Toraciche - UOC Pneumologia | Roma | Lazio | Italy | 00168 |
| 20 | Az. Osp.Univ.San Martino; Pneumologia | Genova | Liguria | Italy | 16132 |
| 21 | ASST Rhodense; U.O.C. Pneumologia | Garbagnate Milanese (MI) | Lombardia | Italy | 20024 |
| 22 | Ospedale Policlinico S. Matteo; S.C. Pneumologia | Pavia | Lombardia | Italy | 27100 |
| 23 | Pres. Osp. Unico ZT9 - Ospedale Generale Provinciale; U.O.C. Pneumologia | Macerata | Marche | Italy | 62100 |
| 24 | A.O.U. S. Luigi Gonzaga; Interstiziopatie Malattie Rare Polmone | Orbassano (to) | Piemonte | Italy | 10043 |
| 25 | A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale | Sassari | Sardegna | Italy | 07100 |
| 26 | Az. Osp. Univ. P. Giaccone; UOC di Pneumologia | Palermo | Sicilia | Italy | 90127 |
| 27 | Azienda Ospedaliero-Universitaria Careggi; SOD Pneumologia e Fisiopatologia Toracico Polmonare | Firenze | Toscana | Italy | 50134 |
| 28 | Admiraal de Ruijter Ziekenhuis | Goes | Netherlands | 4462 RA | |
| 29 | Erasmus Medisch Centrum | Rotterdam | Netherlands | 3000 CA | |
| 30 | Isala | Zwolle | Netherlands | 8025 AB | |
| 31 | SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF | Sankt-peterburg | Leningrad | Russian Federation | 197022 |
| 32 | Pulmonologii NII FMBA of Russia | Moscow | Moskovskaja Oblast | Russian Federation | |
| 33 | SBI at Rostov Region "Regional Clinical Hospital #2" | Rostov-na-donu | Rostov | Russian Federation | 344029 |
| 34 | SBIH "Chelyabinsk Regional Clinical Hospital" | Chelyabinsk | Sverdlovsk | Russian Federation | 454076 |
| 35 | Municipal Healthcare Institution City Clinical Hospital #3 named after M.A. Podgorbunskogo | Kemerovo | Russian Federation | 650099 | |
| 36 | SBIH at Vladimir Region "Regional Clinical Hospital" | Vladimir | Russian Federation | 600023 | |
| 37 | Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1" | Voronezh | Russian Federation | 394066 |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
More Information
Publications
None provided.- MA39297
- 2016-005114-22
Study Results
Participant Flow
| Recruitment Details | The study enrolled participants in Canada, France, Ireland, Italy, the Netherlands, and Russia. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | IPF Participants | Non-IPF ILD Participants | Non-ILD Participants | Participants Without Diagnosis |
|---|---|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | IPF Participants | Non-IPF ILD Participants | Non-ILD Participants | Participants Without Diagnosis | Total |
|---|---|---|---|---|---|
| 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 Participants | 68 | 62 | 9 | 39 | 178 |
| Age (Years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Years] |
69.3
(6.97)
|
65.1
(9.99)
|
69.6
(7.7)
|
71.2
(8.64)
|
68.3
(8.8)
|
| Sex: Female, Male (Count of 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 (Number) [Number] | |||||
| American Indian or Alaskan Native |
1
1.5%
|
0
0%
|
0
0%
|
0
0%
|
1
0.6%
|
| White |
62
91.2%
|
50
80.6%
|
7
77.8%
|
24
61.5%
|
143
80.3%
|
| Unknown |
0
0%
|
1
1.6%
|
0
0%
|
0
0%
|
1
0.6%
|
| Missing |
5
7.4%
|
11
17.7%
|
2
22.2%
|
15
38.5%
|
33
18.5%
|
| Race/Ethnicity, Customized (Participant) [Number] | |||||
| 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
|
Outcome Measures
| 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 |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants diagnosed with IPF. Only participants for whom data were collected are included in the analysis. |
| Arm/Group Title | IPF Participants |
|---|---|
| Arm/Group Description | Participants diagnosed with Idiopathic Pulmonary Fibrosis (IPF) |
| Measure Participants | 64 |
| Mean (Standard Deviation) [milliliter (mL)] |
-308.7
(1268.72)
|
| 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 |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| Arm/Group Description | Participants diagnosed with an Interstitial Lung Disease (ILD) other than Idiopathic Pulmonary Fibrosis (non-IPF) |
| Measure Participants | 59 |
| Mean (Standard Deviation) [mL] |
57.5
(1277.03)
|
| 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 |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|
| 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) |
| Measure Participants | 68 | 62 |
| Baseline |
2845.6
(814.83)
|
2782.4
(870.24)
|
| Change from Baseline at End of Study Visit |
-51.3
(270.56)
|
-27.1
(265.52)
|
| 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 |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|
| 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) |
| Measure Participants | 68 | 62 |
| Baseline |
82.8
(18.74)
|
83.9
(17.82)
|
| Change form Baseline at End of Study Visit |
-0.6
(7.26)
|
-0.6
(8.49)
|
| 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 |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|
| 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) |
| Measure Participants | 68 | 62 |
| Baseline |
434.6
(117.30)
|
429.4
(139.51)
|
| Change from Baseline at End of Study Visit |
4.4
(96.18)
|
6.4
(87.97)
|
| 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 |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|
| 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) |
| Measure Participants | 66 | 61 |
| Mean (Standard Deviation) [Steps per Day] |
-1237.2
(14146.07)
|
-13407.3
(72612.82)
|
| Title | Calorie Expenditure in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured by Daily Home Accelerometry |
|---|---|
| Description | |
| Time Frame | From inclusion into the study to end of the study (up to 18 months) |
Outcome Measure Data
| 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 |
|---|---|---|
| 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) |
| Measure Participants | 68 | 62 |
| Number [Calorie] |
NA
|
NA
|
| Title | Change in the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Total Score by Visit During the Peri-Diagnostic Period |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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 |
| Measure Participants | 68 | 62 | 9 | 39 |
| Baseline |
60.57
(17.633)
|
55.70
(14.203)
|
54.22
(11.703)
|
60.47
(15.728)
|
| Change from Baseline at End of Study Visit |
-0.45
(9.709)
|
3.98
(11.851)
|
6.03
(14.294)
|
4.01
(9.313)
|
| Title | Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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 |
| Measure Participants | 68 | 61 | 9 | 32 |
| Grade 0 |
12
17.6%
|
10
16.1%
|
2
22.2%
|
6
15.4%
|
| Grade 1 |
8
11.8%
|
8
12.9%
|
1
11.1%
|
11
28.2%
|
| Grade 2 |
7
10.3%
|
9
14.5%
|
3
33.3%
|
2
5.1%
|
| Grade 3 |
3
4.4%
|
2
3.2%
|
1
11.1%
|
1
2.6%
|
| Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Grade 0 |
22
32.4%
|
17
27.4%
|
3
33.3%
|
2
5.1%
|
| Grade 1 |
31
45.6%
|
25
40.3%
|
0
0%
|
0
0%
|
| Grade 2 |
10
14.7%
|
16
25.8%
|
3
33.3%
|
1
2.6%
|
| Grade 3 |
5
7.4%
|
3
4.8%
|
2
22.2%
|
0
0%
|
| Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Grade 0 |
2
2.9%
|
1
1.6%
|
||
| Grade 1 |
4
5.9%
|
2
3.2%
|
||
| Grade 2 |
0
0%
|
0
0%
|
||
| Grade 3 |
0
0%
|
0
0%
|
||
| Grade 4 |
0
0%
|
0
0%
|
||
| Grade 0 |
20
29.4%
|
17
27.4%
|
3
33.3%
|
13
33.3%
|
| Grade 1 |
30
44.1%
|
25
40.3%
|
1
11.1%
|
15
38.5%
|
| Grade 2 |
10
14.7%
|
16
25.8%
|
3
33.3%
|
3
7.7%
|
| Grade 3 |
5
7.4%
|
3
4.8%
|
2
22.2%
|
1
2.6%
|
| Grade 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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 |
| Measure Participants | 68 | 62 | 9 | 38 |
| Level 1 |
33
48.5%
|
25
40.3%
|
2
22.2%
|
24
61.5%
|
| Level 2 |
16
23.5%
|
15
24.2%
|
2
22.2%
|
9
23.1%
|
| Level 3 |
14
20.6%
|
21
33.9%
|
5
55.6%
|
4
10.3%
|
| Level 4 |
5
7.4%
|
1
1.6%
|
0
0%
|
1
2.6%
|
| Level 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Missing |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Level 1 |
55
80.9%
|
52
83.9%
|
6
66.7%
|
34
87.2%
|
| Level 2 |
7
10.3%
|
6
9.7%
|
2
22.2%
|
4
10.3%
|
| Level 3 |
6
8.8%
|
4
6.5%
|
1
11.1%
|
0
0%
|
| Level 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Level 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Missing |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Level 1 |
32
47.1%
|
29
46.8%
|
4
44.4%
|
20
51.3%
|
| Level 2 |
19
27.9%
|
16
25.8%
|
2
22.2%
|
10
25.6%
|
| Level 3 |
16
23.5%
|
15
24.2%
|
2
22.2%
|
4
10.3%
|
| Level 4 |
1
1.5%
|
2
3.2%
|
0
0%
|
4
10.3%
|
| Level 5 |
0
0%
|
0
0%
|
1
11.1%
|
0
0%
|
| Missing |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Level 1 |
29
42.6%
|
25
40.3%
|
3
33.3%
|
20
51.3%
|
| Level 2 |
22
32.4%
|
22
35.5%
|
2
22.2%
|
10
25.6%
|
| Level 3 |
17
25%
|
14
22.6%
|
3
33.3%
|
4
10.3%
|
| Level 4 |
0
0%
|
1
1.6%
|
1
11.1%
|
3
7.7%
|
| Level 5 |
0
0%
|
0
0%
|
0
0%
|
1
2.6%
|
| Missing |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Level 1 |
38
55.9%
|
24
38.7%
|
5
55.6%
|
19
48.7%
|
| Level 2 |
22
32.4%
|
20
32.3%
|
2
22.2%
|
12
30.8%
|
| Level 3 |
5
7.4%
|
15
24.2%
|
2
22.2%
|
7
17.9%
|
| Level 4 |
2
2.9%
|
2
3.2%
|
0
0%
|
0
0%
|
| Level 5 |
1
1.5%
|
1
1.6%
|
0
0%
|
0
0%
|
| Missing |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Level 1 |
16
23.5%
|
11
17.7%
|
1
11.1%
|
13
33.3%
|
| Level 2 |
4
5.9%
|
9
14.5%
|
2
22.2%
|
4
10.3%
|
| Level 3 |
9
13.2%
|
5
8.1%
|
2
22.2%
|
1
2.6%
|
| Level 4 |
1
1.5%
|
3
4.8%
|
2
22.2%
|
2
5.1%
|
| Level 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Missing |
0
0%
|
1
1.6%
|
0
0%
|
1
2.6%
|
| Level 1 |
25
36.8%
|
25
40.3%
|
5
55.6%
|
20
51.3%
|
| Level 2 |
3
4.4%
|
2
3.2%
|
2
22.2%
|
0
0%
|
| Level 3 |
1
1.5%
|
1
1.6%
|
0
0%
|
0
0%
|
| Level 4 |
1
1.5%
|
0
0%
|
0
0%
|
0
0%
|
| Level 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Missing |
0
0%
|
1
1.6%
|
0
0%
|
1
2.6%
|
| Level 1 |
15
22.1%
|
15
24.2%
|
2
22.2%
|
9
23.1%
|
| Level 2 |
10
14.7%
|
6
9.7%
|
3
33.3%
|
6
15.4%
|
| Level 3 |
4
5.9%
|
7
11.3%
|
2
22.2%
|
4
10.3%
|
| Level 4 |
1
1.5%
|
0
0%
|
0
0%
|
0
0%
|
| Level 5 |
0
0%
|
0
0%
|
0
0%
|
1
2.6%
|
| Missing |
0
0%
|
1
1.6%
|
0
0%
|
1
2.6%
|
| Level 1 |
15
22.1%
|
15
24.2%
|
1
11.1%
|
12
30.8%
|
| Level 2 |
11
16.2%
|
7
11.3%
|
4
44.4%
|
3
7.7%
|
| Level 3 |
3
4.4%
|
5
8.1%
|
0
0%
|
4
10.3%
|
| Level 4 |
1
1.5%
|
1
1.6%
|
2
22.2%
|
0
0%
|
| Level 5 |
0
0%
|
0
0%
|
0
0%
|
1
2.6%
|
| Missing |
0
0%
|
1
1.6%
|
0
0%
|
1
2.6%
|
| Level 1 |
14
20.6%
|
12
19.4%
|
2
22.2%
|
10
25.6%
|
| Level 2 |
11
16.2%
|
10
16.1%
|
4
44.4%
|
8
20.5%
|
| Level 3 |
3
4.4%
|
6
9.7%
|
1
11.1%
|
1
2.6%
|
| Level 4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Level 5 |
2
2.9%
|
0
0%
|
0
0%
|
1
2.6%
|
| Missing |
0
0%
|
1
1.6%
|
0
0%
|
1
2.6%
|
| Level 1 |
31
45.6%
|
26
41.9%
|
2
22.2%
|
2
5.1%
|
| Level 2 |
19
27.9%
|
17
27.4%
|
3
33.3%
|
0
0%
|
| Level 3 |
12
17.6%
|
9
14.5%
|
2
22.2%
|
0
0%
|
| Level 4 |
3
4.4%
|
6
9.7%
|
1
11.1%
|
0
0%
|
| Level 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Missing |
3
4.4%
|
4
6.5%
|
0
0%
|
1
2.6%
|
| Level 1 |
55
80.9%
|
44
71%
|
6
66.7%
|
2
5.1%
|
| Level 2 |
3
4.4%
|
10
16.1%
|
1
11.1%
|
0
0%
|
| Level 3 |
6
8.8%
|
4
6.5%
|
1
11.1%
|
0
0%
|
| Level 4 |
1
1.5%
|
0
0%
|
0
0%
|
0
0%
|
| Level 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Missing |
3
4.4%
|
4
6.5%
|
0
0%
|
1
2.6%
|
| Level 1 |
31
45.6%
|
27
43.5%
|
6
66.7%
|
2
5.1%
|
| Level 2 |
20
29.4%
|
14
22.6%
|
1
11.1%
|
0
0%
|
| Level 3 |
9
13.2%
|
14
22.6%
|
1
11.1%
|
0
0%
|
| Level 4 |
4
5.9%
|
3
4.8%
|
0
0%
|
0
0%
|
| Level 5 |
1
1.5%
|
0
0%
|
0
0%
|
0
0%
|
| Missing |
3
4.4%
|
4
6.5%
|
0
0%
|
1
2.6%
|
| Level 1 |
32
47.1%
|
34
54.8%
|
2
22.2%
|
1
2.6%
|
| Level 2 |
22
32.4%
|
14
22.6%
|
1
11.1%
|
1
2.6%
|
| Level 3 |
10
14.7%
|
6
9.7%
|
3
33.3%
|
0
0%
|
| Level 4 |
1
1.5%
|
4
6.5%
|
2
22.2%
|
0
0%
|
| Level 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Missing |
3
4.4%
|
4
6.5%
|
0
0%
|
1
2.6%
|
| Level 1 |
30
44.1%
|
25
40.3%
|
4
44.4%
|
1
2.6%
|
| Level 2 |
21
30.9%
|
17
27.4%
|
1
11.1%
|
1
2.6%
|
| Level 3 |
10
14.7%
|
13
21%
|
1
11.1%
|
0
0%
|
| Level 4 |
2
2.9%
|
3
4.8%
|
2
22.2%
|
0
0%
|
| Level 5 |
2
2.9%
|
0
0%
|
0
0%
|
0
0%
|
| Missing |
3
4.4%
|
4
6.5%
|
0
0%
|
1
2.6%
|
| Level 1 |
2
2.9%
|
0
0%
|
||
| Level 2 |
1
1.5%
|
2
3.2%
|
||
| Level 3 |
2
2.9%
|
1
1.6%
|
||
| Level 4 |
0
0%
|
0
0%
|
||
| Level 5 |
0
0%
|
0
0%
|
||
| Missing |
1
1.5%
|
0
0%
|
||
| Level 1 |
4
5.9%
|
2
3.2%
|
||
| Level 2 |
0
0%
|
1
1.6%
|
||
| Level 3 |
1
1.5%
|
0
0%
|
||
| Level 4 |
0
0%
|
0
0%
|
||
| Level 5 |
0
0%
|
0
0%
|
||
| Missing |
1
1.5%
|
0
0%
|
||
| Level 1 |
2
2.9%
|
2
3.2%
|
||
| Level 2 |
2
2.9%
|
0
0%
|
||
| Level 3 |
1
1.5%
|
1
1.6%
|
||
| Level 4 |
0
0%
|
0
0%
|
||
| Level 5 |
0
0%
|
0
0%
|
||
| Missing |
1
1.5%
|
0
0%
|
||
| Level 1 |
1
1.5%
|
2
3.2%
|
||
| Level 2 |
4
5.9%
|
0
0%
|
||
| Level 3 |
0
0%
|
1
1.6%
|
||
| Level 4 |
0
0%
|
0
0%
|
||
| Level 5 |
0
0%
|
0
0%
|
||
| Missing |
1
1.5%
|
0
0%
|
||
| Level 1 |
3
4.4%
|
0
0%
|
||
| Level 2 |
1
1.5%
|
2
3.2%
|
||
| Level 3 |
1
1.5%
|
1
1.6%
|
||
| Level 4 |
0
0%
|
0
0%
|
||
| Level 5 |
0
0%
|
0
0%
|
||
| Missing |
1
1.5%
|
0
0%
|
||
| Level 1 |
33
48.5%
|
28
45.2%
|
2
22.2%
|
16
41%
|
| Level 2 |
15
22.1%
|
15
24.2%
|
3
33.3%
|
2
5.1%
|
| Level 3 |
11
16.2%
|
14
22.6%
|
3
33.3%
|
4
10.3%
|
| Level 4 |
4
5.9%
|
3
4.8%
|
1
11.1%
|
2
5.1%
|
| Level 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Missing |
2
2.9%
|
2
3.2%
|
0
0%
|
9
23.1%
|
| Level 1 |
54
79.4%
|
46
74.2%
|
6
66.7%
|
22
56.4%
|
| Level 2 |
3
4.4%
|
12
19.4%
|
2
22.2%
|
1
2.6%
|
| Level 3 |
5
7.4%
|
2
3.2%
|
1
11.1%
|
1
2.6%
|
| Level 4 |
1
1.5%
|
0
0%
|
0
0%
|
0
0%
|
| Level 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Missing |
2
2.9%
|
2
3.2%
|
0
0%
|
9
23.1%
|
| Level 1 |
32
47.1%
|
25
40.3%
|
4
44.4%
|
14
35.9%
|
| Level 2 |
16
23.5%
|
18
29%
|
0
0%
|
5
12.8%
|
| Level 3 |
11
16.2%
|
15
24.2%
|
4
44.4%
|
4
10.3%
|
| Level 4 |
3
4.4%
|
2
3.2%
|
1
11.1%
|
1
2.6%
|
| Level 5 |
1
1.5%
|
0
0%
|
0
0%
|
0
0%
|
| Missing |
2
2.9%
|
2
3.2%
|
0
0%
|
9
23.1%
|
| Level 1 |
30
44.1%
|
34
54.8%
|
2
22.2%
|
14
35.9%
|
| Level 2 |
20
29.4%
|
16
25.8%
|
1
11.1%
|
3
7.7%
|
| Level 3 |
13
19.1%
|
8
12.9%
|
4
44.4%
|
6
15.4%
|
| Level 4 |
0
0%
|
2
3.2%
|
2
22.2%
|
1
2.6%
|
| Level 5 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Missing |
2
2.9%
|
2
3.2%
|
0
0%
|
9
23.1%
|
| Level 1 |
28
41.2%
|
25
40.3%
|
4
44.4%
|
13
33.3%
|
| Level 2 |
21
30.9%
|
19
30.6%
|
1
11.1%
|
10
25.6%
|
| Level 3 |
10
14.7%
|
15
24.2%
|
2
22.2%
|
0
0%
|
| Level 4 |
2
2.9%
|
1
1.6%
|
2
22.2%
|
1
2.6%
|
| Level 5 |
2
2.9%
|
0
0%
|
0
0%
|
0
0%
|
| Missing |
2
2.9%
|
2
3.2%
|
0
0%
|
9
23.1%
|
| Title | The EuroQol Visual Analogue Scale (EQ-VAS) Health State Profile Scores During the Peri-Diagnostic Period During the Peri-Diagnostic Period |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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 |
| Measure Participants | 68 | 62 | 9 | 39 |
| Health State Index Baseline |
71.7
(15.96)
|
67.4
(20.11)
|
68.9
(17.99)
|
76.2
(17.09)
|
| Health State Index Pre-diagnosis |
69.8
(15.50)
|
71.5
(15.89)
|
65.7
(19.88)
|
73.5
(16.06)
|
| Health State Index Initial diagnosis |
69.5
(16.23)
|
68.3
(18.03)
|
70.4
(19.92)
|
72.5
(10.61)
|
| Health State Index Post-diagnosis |
69.0
(25.10)
|
76.7
(12.58)
|
||
| Health State Index End of Study |
69.5
(16.46)
|
69.8
(17.21)
|
67.0
(21.21)
|
74.2
(16.85)
|
| Title | The EuroQoL 5-dimension 5-level Questionnaire Index Utility Scores During the Peri-Diagnostic Period |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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 |
| Measure Participants | 68 | 62 | 9 | 39 |
| Index utility score Baseline |
0.83
(0.140)
|
0.79
(0.143)
|
0.67
(0.250)
|
0.80
(0.187)
|
| Index utility score Pre-diagnosis |
0.82
(0.154)
|
0.80
(0.152)
|
0.68
(0.237)
|
0.83
(0.182)
|
| Index utility score Initial diagnosis |
0.81
(0.162)
|
0.78
(0.197)
|
0.63
(0.331)
|
0.92
(0.013)
|
| Index utility score Post-diagnosis |
0.81
(0.149)
|
0.75
(0.123)
|
||
| Index utility score End of Study |
0.81
(0.164)
|
0.80
(0.164)
|
0.62
(0.312)
|
0.81
(0.197)
|
| Title | Fatigue Assessment Scale (FAS) Score During the Peri-Diagnostic Period |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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 |
| Measure Participants | 68 | 62 | 9 | 39 |
| Baseline |
21.8
(6.44)
|
21.8
(6.89)
|
21.1
(7.22)
|
20.9
(6.99)
|
| Initial diagnosis |
21.7
(6.66)
|
22.6
(7.33)
|
24.7
(9.11)
|
18.0
(2.83)
|
| End of study |
22.0
(6.17)
|
22.0
(7.59)
|
26.1
(9.33)
|
20.6
(6.31)
|
| Title | Cough, Urge to Cough, and Fatigue Visual Analogue Scales (VAS) Score During the Peri-Diagnostic Period |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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 |
| Measure Participants | 68 | 62 | 9 | 39 |
| Baseline (Cough) |
34.0
(25.44)
|
26.9
(20.66)
|
17.9
(21.99)
|
27.4
(20.38)
|
| Pre-diagnosis (Cough) |
36.8
(25.50)
|
25.4
(20.90)
|
11.4
(14.03)
|
31.4
(24.34)
|
| Initial diagnosis (Cough) |
36.3
(29.60)
|
21.9
(18.88)
|
17.1
(21.69)
|
32.0
(36.77)
|
| Post-diagnosis (Cough) |
25.6
(20.94)
|
17.0
(9.16)
|
||
| End of Study (Cough) |
34.7
(26.64)
|
24.0
(19.42)
|
19.3
(21.35)
|
31.2
(25.92)
|
| Baseline (Urge to Cough) |
33.3
(25.41)
|
28.6
(21.53)
|
16.4
(17.20)
|
25.8
(21.27)
|
| Pre-diagnosis (Urge to Cough) |
37.6
(25.73)
|
23.1
(20.03)
|
13.2
(13.51)
|
30.4
(24.29)
|
| Initial diagnosis (Urge to Cough) |
36.4
(29.22)
|
22.9
(19.02)
|
13.7
(19.86)
|
38.5
(47.38)
|
| Post-diagnosis (Urge to Cough) |
23.5
(15.79)
|
10.8
(9.00)
|
||
| End of Study (Urge to Cough) |
33.8
(25.18)
|
24.3
(20.14)
|
16.2
(20.00)
|
36.3
(29.75)
|
| Baseline (Fatigue) |
38.4
(27.15)
|
39.4
(24.29)
|
30.0
(31.18)
|
33.2
(26.89)
|
| Pre-diagnosis (Fatigue) |
34.1
(27.50)
|
31.0
(22.68)
|
32.5
(26.11)
|
32.0
(28.29)
|
| Initial diagnosis (Fatigue) |
37.5
(27.50)
|
35.6
(23.79)
|
31.1
(30.00)
|
17.0
(5.66)
|
| Post-diagnosis (Fatigue) |
30.4
(23.24)
|
25.3
(19.48)
|
||
| End of Study (Fatigue) |
38.3
(26.15)
|
34.6
(23.54)
|
35.5
(32.16)
|
31.5
(24.18)
|
| 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 |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|
| 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) |
| Measure Participants | 57 | 55 |
| Number [Pearson's Correlation Coefficients] |
-0.06
|
0.35
|
| 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 |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|
| 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) |
| Measure Participants | 54 | 52 |
| Number [Pearson's Correlation Coefficients] |
-0.04
|
0.06
|
| Title | Percentage of Participants Requiring Respiratory-Related Hospitalizations |
|---|---|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants. |
| Arm/Group Title | IPF Participants | Non-IPF ILD Participants | Non-ILD Participants | Participants Without Diagnosis |
|---|---|---|---|---|
| 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 |
| Measure Participants | 68 | 62 | 9 | 39 |
| With at least one event during pre-diagnosis period |
5.9
8.7%
|
4.8
7.7%
|
22.2
246.7%
|
2.6
6.7%
|
| With at least one event during post-diagnosis period |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Percentage of Participants With Non-Elective Hospitalizations |
|---|---|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants. |
| Arm/Group Title | IPF Participants | Non-IPF ILD Participants | Non-ILD Participants | Participants Without Diagnosis |
|---|---|---|---|---|
| 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 |
| Measure Participants | 68 | 62 | 9 | 39 |
| With at least one event during pre-diagnosis period |
8.8
12.9%
|
4.8
7.7%
|
22.2
246.7%
|
7.7
19.7%
|
| With at least one event during post-diagnosis period |
2.9
4.3%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Percentage of Participants With Investigator-Reported Acute Exacerbations |
|---|---|
| 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) |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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 |
| Measure Participants | 62 | 62 | 9 | 39 |
| With at least one acute exacerbation pre-diagnosis period |
1.5
2.2%
|
0
0%
|
0
0%
|
0
0%
|
| With at least one acute exacerbation during post-diagnosis period |
0
0%
|
0
0%
|
||
| With at least one triggered acute exacerbation pre-diagnosis period |
4.4
6.5%
|
0
0%
|
0
0%
|
0
0%
|
| With at least one triggered acute exacerbation during post-diagnosis period |
0
0%
|
0
0%
|
||
| With at least one idiopathic acute exacerbation pre-diagnosis period |
0
0%
|
1.6
2.6%
|
0
0%
|
0
0%
|
| With at least one idiopathic acute exacerbation during post-diagnosis period |
0
0%
|
0
0%
|
| Title | Percentage of Participants Who Died Due to Any Cause |
|---|---|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants. |
| Arm/Group Title | IPF Participants | Non-IPF ILD Participants | Non-ILD Participants | Participants Without Diagnosis |
|---|---|---|---|---|
| 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 |
| Measure Participants | 68 | 62 | 9 | 39 |
| Number [Percentage of Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Percentage of Participants Who Died Due to Respiratory-Related Diseases |
|---|---|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants. |
| Arm/Group Title | IPF Participants | Non-IPF ILD Participants | Non-ILD Participants | Participants Without Diagnosis |
|---|---|---|---|---|
| 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 |
| Measure Participants | 68 | 62 | 9 | 39 |
| Number [Percentage of Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Percentage of Participants With Events Related to the Study Assessments |
|---|---|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| All enrolled participants. |
| Arm/Group Title | IPF Participants | Non-IPF ILD Participants | Non-ILD Participants | Participants Without Diagnosis |
|---|---|---|---|---|
| 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 |
| Measure Participants | 68 | 62 | 9 | 39 |
| Number [Percentage of Participants] |
0
0%
|
3.2
5.2%
|
0
0%
|
5.1
13.1%
|
Adverse Events
| 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 | ||||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/68 (0%) | 0/62 (0%) | 0/9 (0%) | 0/39 (0%) | ||||
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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||
Other (Not Including 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
| Name/Title | Medical Communications |
|---|---|
| Organization | Hoffmann-La Roche |
| Phone | 800 821-8590 |
| genentech@druginfo.com |
- MA39297
- 2016-005114-22