Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Observational [Patient Registry]|
|Eligible Ages||18 Years and Over|
Inclusion Criteria:Newly diagnosed patients with F-ILD according to the ATS/ERS criteria by a multidisciplinary ILD team :
- - MDT diagnosis ≤ 6 months before inclusion.
- - Treatment for F-ILD ≤ than 1 month.
- - Not able to speak, read or write in the native language of the country where the patient is included.
- - Not able to comply to the study protocol, according to the judgement of the investigator and/or patient.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Erasmus Medical Center|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Marlies Wijsenbeek, MD PhDWim Wuyts, MD PhDAnna-Maria Hoffmann-Vold, MD PhDMichael Kreuter, MD PhDPhilip Molyneaux, MD PhD|
|Principal Investigator Affiliation||Erasmus MCUniversitair Ziekenhuis LeuvenOslo University HospitalInterdisciplinary Center for Sarcoidosis, Thoraxklinik, University Hospital HeidelbergRoyal Brompton Hospital, Guys and St Thomas' Hospital NHS Foundation Trust.|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Nowadays, identifying disease progression will have direct treatment implications in patients with fibrotic Interstitial lung diseases (F-ILDs). eHealth could be a possible solution for close monitoring and detecting disease progression, at a low burden for patients and healthcare providers. The main aim of the I-FILE study will be to evaluate feasibility of a patient-led registry using home spirometry to monitor disease progression in patients with F-ILD. The secondary aim will be to better validate existing health-related quality of life questionnaires to assess the impact of disease and treatment in these patients. In total 700 patients with newly diagnosed F-ILD will be included. Patients will perform daily home spirometry in the first three months followed by once weekly measurements with a follow up period of 2 years. In addition, patient-reported outcomes (PROMs) will be completed online every 6 months. Results are encrypted and directly sent to a secured server through the online I-FILE application.
: Single Group Assignment
Intervention group without a control group
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.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.