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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03261037
• Date of registration: 22/08/2017
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study to Characterize the Disease Behavior of Idiopathic Pulmonary Fibrosis (IPF) and Interstitial Lung Disease (ILD) During the Peri-Diagnostic Period
• Scientific title: An International Study to Characterize the Disease Behaviour of Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease During the Peri-Diagnostic Period
• Date of first enrolment: December 25, 2017
• Target sample size: 179
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03261037
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada, France, Ireland, Italy, Netherlands, Russian Federation, United Kingdom

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Interstitial Lung Disease

Intervention(s)

Other: Accelerometry

Other: Spirometry

Other: 6MWT

Primary Outcome(s)

Forced Vital Capacity (FVC) Decline in Participants With IPF, Measured in Milliliters (mL) by Daily Home Spirometry [Time Frame: From inclusion into the study to end of the study (up to 18 months)]

Secondary Outcome(s)

Cough, Urge to Cough, and Fatigue Visual Analogue Scales (VAS) Score [Time Frame: From inclusion into the study to end of the study (up to 18 months)]

King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Score [Time Frame: From inclusion into the study to end of the study (up to 18 months)]

Percent Predicted FVC, Measured by Site Spirometry [Time Frame: From inclusion into the study to end of the study (up to 18 months)]

FVC Decline, Measured in mL by Site Spirometry [Time Frame: From inclusion into the study to end of the study (up to 18 months)]

Percentage of Participants Requiring Respiratory-Related Hospitalizations [Time Frame: From inclusion into the study to end of the study (up to 18 months)]

Fatigue Assessment Scale (FAS) Score [Time Frame: From inclusion into the study to end of the study (up to 18 months)]

Number of Footsteps Per Day, Measured by Daily Home Accelerometry [Time Frame: From inclusion into the study to end of the study (up to 18 months)]

Distance Walked (Meters) on the 6MWT, Assessed at Site [Time Frame: From inclusion into the study to end of the study (up to 18 months)]

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 [Time Frame: From inclusion into the study to end of the study (up to 18 months)]

Modified Medical Research Council (mMRC) Dyspnea Scale Score [Time Frame: From inclusion into the study to end of the study (up to 18 months)]

Percentage of Participants With Non-Elective Hospitalizations [Time Frame: From inclusion into the study to end of the study (up to 18 months)]

Percentage of Participants Who Died due to Any Cause [Time Frame: From inclusion into the study to end of the study (up to 18 months)]

Percentage of Participants With Events Related to the Study Assessments [Time Frame: From inclusion into the study to end of the study (up to 18 months)]

Calorie Expenditure, Measured by Daily Home Accelerometry [Time Frame: From inclusion into the study to end of the study (up to 18 months)]

Percentage of Participants Who Died due to Respiratory-Related Diseases [Time Frame: From inclusion into the study to end of the study (up to 18 months)]

FVC Decline in Participants With Non-IPF ILD, Measured in mL by Daily Home Spirometry [Time Frame: From inclusion into the study to end of the study (up to 18 months)]

Pearson's Correlation Coefficient of FVC (mL) Between Home and Site Spirometry [Time Frame: From inclusion into the study to end of the study (up to 18 months)]

Percentage of Participants With Investigator-Reported Acute Exacerbations [Time Frame: From inclusion into the study to end of the study (up to 18 months)]

The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Score [Time Frame: From inclusion into the study to end of the study (up to 18 months)]

Secondary ID(s)

2016-005114-22

MA39297

Source(s) of Monetary Support

Please refer to primary and secondary sponsors