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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

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ClinicalTrials.gov Identifier: NCT03261037
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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
Idiopathic Pulmonary Fibrosis Interstitial Lung Disease Other: Spirometry Other: Accelerometry Other: 6MWT Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An International Study to Characterize the Disease Behaviour of Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease During the Peri-Diagnostic Period
Actual Study Start Date : December 25, 2017
Estimated Primary Completion Date : August 4, 2020
Estimated Study Completion Date : August 4, 2020


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 Measures :
  1. 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) ]
  2. FVC Decline, Measured in mL by Site Spirometry [ Time Frame: From inclusion into the study to end of the study (up to 18 months) ]
  3. Percent Predicted FVC, Measured by Site Spirometry [ Time Frame: From inclusion into the study to end of the study (up to 18 months) ]
  4. 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) ]
  5. 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) ]
  6. Calorie Expenditure, Measured by Daily Home Accelerometry [ Time Frame: From inclusion into the study to end of the study (up to 18 months) ]
  7. 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) ]
  8. Modified Medical Research Council (mMRC) Dyspnea Scale Score [ Time Frame: From inclusion into the study to end of the study (up to 18 months) ]
  9. 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) ]
  10. Fatigue Assessment Scale (FAS) Score [ Time Frame: From inclusion into the study to end of the study (up to 18 months) ]
  11. 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) ]
  12. 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) ]
  13. 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) ]
  14. Percentage of Participants Requiring Respiratory-Related Hospitalizations [ Time Frame: From inclusion into the study to end of the study (up to 18 months) ]
  15. Percentage of Participants With Non-Elective Hospitalizations [ Time Frame: From inclusion into the study to end of the study (up to 18 months) ]
  16. Percentage of Participants With Investigator-Reported Acute Exacerbations [ Time Frame: From inclusion into the study to end of the study (up to 18 months) ]
  17. 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) ]
  18. 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) ]
  19. 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) ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261037


Contacts
Contact: Reference Study ID Number: MA39297 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03261037     History of Changes
Other Study ID Numbers: MA39297
2016-005114-22 ( EudraCT Number )
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fibrosis
Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Pathologic Processes
Respiratory Tract Diseases