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Assessment of the Usability and Feasibility of a Breath-based Home-monitoring Tool for Asthma, CF, COPD and PCD Disease Stability

Assessment of the Usability and Feasibility of a Breath-based Home-monitoring Tool for Asthma, CF, COPD and PCD Disease Stability - PHEASANT Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57546
Enrollment
65
Registered
2024-09-19
Start date
2025-08-25
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic lung diseases (asthma, cystic fibrosis, primary ciliary dyskinesia and chronic obstructive pulmonary disease) asthma, cystic fibrosis, dysfunctional cilia and COPD

Interventions

None listed

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: Being six years of age or older and Asthma diagnosis is based on: clinical symptoms in combination with treatment according to the 2023 Global Initiative for Asthma (GINA) classification 2 or higher. or CF diagnosis is based on: clinical symptoms in combination with an abnormal sweat test (chloride > 60 mmol/l) and/or identification of mutations in both alleles of the CFTR gene. or PCD diagnosis is based on: a combination of clinical symptoms, abnormal movement of cilia on microscopic evaluation of respiratory epithelial biopsies and epithelial cell cultures, or identification of an ultra-structural defect in the cilia by electron microscopy. or COPD diagnosis is based on a: a combination of clinical symptoms as described in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines AND forced spirometry showing the presence of a post-bronchodilator FEV1/FVC

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: If they have insufficient understanding of the Dutch language to fill out the study questionnaires If they have such severe pulmonary symptoms that they are admitted to a hospital or care facility or need continuous oxygen administration. As this may limit their ability to use the PHEASANT.

Design outcomes

Primary

MeasureTime frame
Main study parameter/endpoint: - Feasibility and usability assessment by User Experience Questionnaires (UEQs) - PHEASANT experiences by semi-structured interview

Secondary

MeasureTime frame
Secondary study parameters/endpoints: - Food intake by food diary - Respiratory disease symptoms: fatigue and dyspnoea (by VAS) - Environmental conditions: humidity, temperature and air pressure Other parameters: - Patient demographics (gender, age, weight, height education etc.) - Disease information (diagnosis, symptoms, medication use etc.)

Countries

Netherlands

Contacts

Public ContactP. Brinkman

Amsterdam UMC

info@amsterdamumc.nl020 44 44 782

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)