N/A
N=178
A Study to Characterize the Disease Behavior of Idiopathic Pulmonary Fibrosis (IPF) and Interstitial Lung Disease (ILD) During the Peri-Diagnostic Period
Idiopathic Pulmonary Fibrosis · Interstitial Lung Disease
Bottom Line
View on ClinicalTrials.gov: NCT03261037 ↗Enrolled (actual)
178
Serious AEs
—
Results posted
Mar 2021
Primary outcome: Primary: Time-Adjusted Semi-Annual Forced Vital Capacity (FVC) Decline in Participants With IPF During the Peri-Diagnostic Period, Measured in Milliliters (mL) by Daily Home Spirometry — -308.7 milliliter (mL)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Spirometry (Other); Accelerometry (Other); 6MWT (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-Adjusted Semi-Annual Forced Vital Capacity (FVC) Decline in Participants With IPF During the Peri-Diagnostic Period, Measured in Milliliters (mL) by Daily Home Spirometry |
-308.7 | — |
| SECONDARY Time-Adjusted Semi-Annual FVC Decline in Participants With Non-IPF ILD During the Peri-Diagnostic Period, Measured in mL by Daily Home Spirometry |
57.5 | — |
| SECONDARY 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 |
2845.6; 2782.4; -51.3; -27.1 | — |
| SECONDARY Change From Baseline in the Percent Predicted FVC in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured by Site Spirometry |
82.8; 83.9; -0.6; -0.6 | — |
| SECONDARY 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 |
434.6; 429.4; 4.4; 6.4 | — |
| SECONDARY Decline in Physical Function Capacity (Steps/Day) in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured by Daily Home Accelerometry |
-1237.2; -13407.3 | — |
| SECONDARY Calorie Expenditure in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period, Measured by Daily Home Accelerometry |
NA; NA | — |
| SECONDARY Change in the King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Total Score by Visit During the Peri-Diagnostic Period |
60.57; 55.70; 54.22; 60.47; -0.45; 3.98 | — |
| SECONDARY Modified Medical Research Council (mMRC) Dyspnea Scale Scores During the Peri-Diagnostic Period |
12; 10; 2; 6; 8; 8 | — |
| SECONDARY The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) 5-Item Health State Profile Scores During the Peri-Diagnostic Period |
33; 25; 2; 24; 16; 15 | — |
| SECONDARY The EuroQol Visual Analogue Scale (EQ-VAS) Health State Profile Scores During the Peri-Diagnostic Period During the Peri-Diagnostic Period |
71.7; 67.4; 68.9; 76.2; 69.8; 71.5 | — |
| SECONDARY The EuroQoL 5-dimension 5-level Questionnaire Index Utility Scores During the Peri-Diagnostic Period |
0.83; 0.79; 0.67; 0.80; 0.82; 0.80 | — |
| SECONDARY Fatigue Assessment Scale (FAS) Score During the Peri-Diagnostic Period |
21.8; 21.8; 21.1; 20.9; 21.7; 22.6 | — |
| SECONDARY Cough, Urge to Cough, and Fatigue Visual Analogue Scales (VAS) Score During the Peri-Diagnostic Period |
34.0; 26.9; 17.9; 27.4; 36.8; 25.4 | — |
| SECONDARY Pearson's Correlation Coefficient of FVC (mL) Between Home and Site Spirometry in IPF and Non-IPF ILD Participants During the Peri-Diagnostic Period |
-0.06; 0.35 | — |
| SECONDARY Pearson's Correlation Coefficient of Physical Functional Capacity Assessed at Home in Terms of the Decline in the Number of Footsteps and on Site in Terms of the Decline in Distance of the 6MWT |
-0.04; 0.06 | — |
| SECONDARY Percentage of Participants Requiring Respiratory-Related Hospitalizations |
5.9; 4.8; 22.2; 2.6; 0; 0 | — |
| SECONDARY Percentage of Participants With Non-Elective Hospitalizations |
8.8; 4.8; 22.2; 7.7; 2.9; 0 | — |
| SECONDARY Percentage of Participants With Investigator-Reported Acute Exacerbations |
1.5; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Who Died Due to Any Cause |
0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Who Died Due to Respiratory-Related Diseases |
0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Events Related to the Study Assessments |
0; 3.2; 0; 5.1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03261037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.