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

Primary Purpose

Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Spirometry
Accelerometry
6MWT
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Idiopathic Pulmonary Fibrosis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Clare'S Mercy Hospital
  • Kingston Health Sciences Centre; research Kingston General Health Research Institute
  • Dr. Syed Anees Medicine Profession Corporation
  • Clinique de pneumologie et du sommeil de Lanaudiere
  • Hopital Louis Pradel; Pneumologie
  • Hopital Cote De Nacre; Pneumologie
  • Ch De Granville; Pneumologie
  • Hopital Calmette; Pneumologie
  • Hopital Arnaud De Villeneuve; Pneumologie A
  • Hopital Tenon;Pneumologie
  • Centre Pneumologie Et Allergie
  • Hopital de Pontchaillou; Service de Pneumologie
  • Ch Bretagne Atlantique; Pneumologie-Oncologie
  • Cork University Hospital
  • St James's Hospital
  • P.O. Clinicizz. 'SS. Annunziata'; U.O.C. Pneumologia
  • Azienda Ospedaliera dei Colli - P. Monaldi; Dip. Medicina Clinica e Chirurgia
  • A.O. Universitaria Policlinico Di Modena; DIP. Malattie Dell'apparato Respiratorio
  • Policlinico A. Gemelli e C.I.C.; Polo Scienze Cardiovascolari e Toraciche - UOC Pneumologia
  • Az. Osp.Univ.San Martino; Pneumologia
  • ASST Rhodense; U.O.C. Pneumologia
  • Ospedale Policlinico S. Matteo; S.C. Pneumologia
  • Pres. Osp. Unico ZT9 - Ospedale Generale Provinciale; U.O.C. Pneumologia
  • A.O.U. S. Luigi Gonzaga; Interstiziopatie Malattie Rare Polmone
  • A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale
  • Az. Osp. Univ. P. Giaccone; UOC di Pneumologia
  • Azienda Ospedaliero-Universitaria Careggi; SOD Pneumologia e Fisiopatologia Toracico Polmonare
  • Admiraal de Ruijter Ziekenhuis
  • Erasmus Medisch Centrum
  • Isala
  • SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
  • Pulmonologii NII FMBA of Russia
  • SBI at Rostov Region "Regional Clinical Hospital #2"
  • SBIH "Chelyabinsk Regional Clinical Hospital"
  • Municipal Healthcare Institution City Clinical Hospital #3 named after M.A. Podgorbunskogo
  • SBIH at Vladimir Region "Regional Clinical Hospital"
  • Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Participants With Suspicion of IPF/ILD

Arm Description

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.

Outcomes

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
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
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
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
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
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
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
Change in the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Total Score by Visit During the Peri-Diagnostic Period
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
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
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
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
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
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
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
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
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
The number of participants requiring the hospitalization were counted during pre- and post-diagnosis period.
Percentage of Participants With Non-Elective Hospitalizations
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
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
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
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
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.

Full Information

First Posted
August 22, 2017
Last Updated
March 2, 2021
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03261037
Brief Title
A Study to Characterize the Disease Behavior of Idiopathic Pulmonary Fibrosis (IPF) and Interstitial Lung Disease (ILD) During the Peri-Diagnostic Period
Official Title
An International Study to Characterize the Disease Behaviour of Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease During the Peri-Diagnostic Period
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 25, 2017 (Actual)
Primary Completion Date
November 27, 2019 (Actual)
Study Completion Date
November 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants With Suspicion of IPF/ILD
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Spirometry
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Accelerometry
Intervention Description
Daily physical functional capacity assessments (e.g., steps per day, calorie expenditure) will be measured on an ongoing basis using the accelerometry device provided.
Intervention Type
Other
Intervention Name(s)
6MWT
Intervention Description
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.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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)
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)
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)
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)
Title
Calorie Expenditure in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured by Daily Home Accelerometry
Time Frame
From inclusion into the study to end of the study (up to 18 months)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
St. Clare'S Mercy Hospital
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Kingston Health Sciences Centre; research Kingston General Health Research Institute
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada
Facility Name
Dr. Syed Anees Medicine Profession Corporation
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 1T3
Country
Canada
Facility Name
Clinique de pneumologie et du sommeil de Lanaudiere
City
Saint-Charles-Borromee
State/Province
Quebec
ZIP/Postal Code
J6E 2B4
Country
Canada
Facility Name
Hopital Louis Pradel; Pneumologie
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Hopital Cote De Nacre; Pneumologie
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Ch De Granville; Pneumologie
City
Granville
ZIP/Postal Code
50406
Country
France
Facility Name
Hopital Calmette; Pneumologie
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Arnaud De Villeneuve; Pneumologie A
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Tenon;Pneumologie
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Centre Pneumologie Et Allergie
City
Perpignan
ZIP/Postal Code
66025
Country
France
Facility Name
Hopital de Pontchaillou; Service de Pneumologie
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Ch Bretagne Atlantique; Pneumologie-Oncologie
City
Vannes
ZIP/Postal Code
56017
Country
France
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Facility Name
St James's Hospital
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
P.O. Clinicizz. 'SS. Annunziata'; U.O.C. Pneumologia
City
Chieti
State/Province
Abruzzo
ZIP/Postal Code
66100
Country
Italy
Facility Name
Azienda Ospedaliera dei Colli - P. Monaldi; Dip. Medicina Clinica e Chirurgia
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
A.O. Universitaria Policlinico Di Modena; DIP. Malattie Dell'apparato Respiratorio
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41124
Country
Italy
Facility Name
Policlinico A. Gemelli e C.I.C.; Polo Scienze Cardiovascolari e Toraciche - UOC Pneumologia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Az. Osp.Univ.San Martino; Pneumologia
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
ASST Rhodense; U.O.C. Pneumologia
City
Garbagnate Milanese (MI)
State/Province
Lombardia
ZIP/Postal Code
20024
Country
Italy
Facility Name
Ospedale Policlinico S. Matteo; S.C. Pneumologia
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Pres. Osp. Unico ZT9 - Ospedale Generale Provinciale; U.O.C. Pneumologia
City
Macerata
State/Province
Marche
ZIP/Postal Code
62100
Country
Italy
Facility Name
A.O.U. S. Luigi Gonzaga; Interstiziopatie Malattie Rare Polmone
City
Orbassano (to)
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
Facility Name
A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale
City
Sassari
State/Province
Sardegna
ZIP/Postal Code
07100
Country
Italy
Facility Name
Az. Osp. Univ. P. Giaccone; UOC di Pneumologia
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90127
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Careggi; SOD Pneumologia e Fisiopatologia Toracico Polmonare
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
Admiraal de Ruijter Ziekenhuis
City
Goes
ZIP/Postal Code
4462 RA
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
Isala
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
City
Sankt-peterburg
State/Province
Leningrad
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Pulmonologii NII FMBA of Russia
City
Moscow
State/Province
Moskovskaja Oblast
Country
Russian Federation
Facility Name
SBI at Rostov Region "Regional Clinical Hospital #2"
City
Rostov-na-donu
State/Province
Rostov
ZIP/Postal Code
344029
Country
Russian Federation
Facility Name
SBIH "Chelyabinsk Regional Clinical Hospital"
City
Chelyabinsk
State/Province
Sverdlovsk
ZIP/Postal Code
454076
Country
Russian Federation
Facility Name
Municipal Healthcare Institution City Clinical Hospital #3 named after M.A. Podgorbunskogo
City
Kemerovo
ZIP/Postal Code
650099
Country
Russian Federation
Facility Name
SBIH at Vladimir Region "Regional Clinical Hospital"
City
Vladimir
ZIP/Postal Code
600023
Country
Russian Federation
Facility Name
Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"
City
Voronezh
ZIP/Postal Code
394066
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34117601
Citation
Wijsenbeek MS, Bendstrup E, Valenzuela C, Henry MT, Moor CC, Jouneau S, Fois AG, Moran-Mendoza O, Anees S, Mirt M, Bengus M, Gilberg F, Kirchgaessler KU, Vancheri C. Disease Behaviour During the Peri-Diagnostic Period in Patients with Suspected Interstitial Lung Disease: The STARLINER Study. Adv Ther. 2021 Jul;38(7):4040-4056. doi: 10.1007/s12325-021-01790-y. Epub 2021 Jun 11.
Results Reference
derived
PubMed Identifier
30506309
Citation
Wijsenbeek M, Bendstrup E, Valenzuela C, Henry MT, Moor C, Bengus M, Perjesi A, Gilberg F, Kirchgaessler KU, Vancheri C. Design of a Study Assessing Disease Behaviour During the Peri-Diagnostic Period in Patients with Interstitial Lung Disease: The STARLINER Study. Adv Ther. 2019 Jan;36(1):232-243. doi: 10.1007/s12325-018-0845-3. Epub 2018 Nov 30.
Results Reference
derived

Learn more about this trial

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

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