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An International Patient-led Registry in Fibrotic Interstitial Lung Diseases Using eHealth Technology

NCT04304898 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 700

Last updated 2024-03-20

No results posted yet for this study

Summary

The I-FILE study is a prospective multicenter, multinational observational study where the feasibility of a patient-led registry using home monitoring in patients with pulmonary fibrosis will be evaluated. The aim of the study is to gain more insights in disease behavior in patients with pulmonary fibrosis, so in future patients with progressive disease can be better identified.

Conditions

Interventions

OTHER

Home spirometry

* Patients will perform daily home spirometry for three months with a Bluetooth-enabled validated, CE-marked home spirometer (Spiro bank Smart, MIR, Italy). Subsequently, patients will perform weekly home spirometry for two years in total. During this period, patients will be asked to perform three measurements each week on the same day. * Hospital-based spirometry will be performed according to international guidelines. * Patients will complete patient-reported outcomes (PROMs) online in the secured application every six months.

Sponsors & Collaborators

Principal Investigators

  • Marlies Wijsenbeek, MD PhD · Erasmus Medical Center

  • Wim Wuyts, MD PhD · Universitair Ziekenhuis Leuven

  • Anna-Maria Hoffmann-Vold, MD PhD · Oslo University Hospital

  • Michael Kreuter, MD PhD · Interdisciplinary Center for Sarcoidosis, Thoraxklinik, University Hospital Heidelberg

  • Philip Molyneaux, MD PhD · Royal Brompton Hospital, Guys and St Thomas' Hospital NHS Foundation Trust.

  • Vincent Cottin, MD PhD · Service de pneumologie, hôpital Louis Pradel, Hospices Civils de Lyon

  • Katarina Antoniou · Laboratory of Molecular and Cellular Pneumonology, Respiratory Medicine Department, School of Medicine, University of Crete, Heraklion, Greece

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2025-07-31
Completion
2026-07-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04304898 on ClinicalTrials.gov