Asthma Bronchiale Asthma
Conditions
Interventions
Study subjects will perform lung function measurements with the Respicorder twice a day at home.
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Severe asthma based on the definition by the 2022 GINA guidelines. • Will start treatment with a biological • aged 18 year or older • Subject should be willing and able to perform the lung function tests and other study-related procedures and comply with study protocol requirements. • Apart from their asthma, subjects should be generally healthy with no history of a clinically relevant medical condition that in the opinion of the investigator might interfere with successful study conduct and no clinically relevant abnormalities on medical history. • Subjects should provide a signed and dated informed consent
Exclusion criteria
Exclusion criteria: • Has been tested positively for COVID-19 in the past month or has not fully recovered from an earlier COVID-19 infection (e.g. post-covid syndrome) • Has been treated with oral corticosteroids as high-dose therapy in the 6 weeks before visit 1. • Has been treated with another biologic within 3 months before start treatment with new biological (e.g. 2 months before the start of the study participation) • Not able to perform spirometry/IOS/FeNO tests correctly • Not able to handle Respicorder well • Subject is a current smoker/vaper, uses recreational drugs, or has >10 packyears • Subject is anticipated not to comply with study protocol or other aspects of the study (at the discretion of the investigator) • Participation to the study is not medically responsible according to the study physician and/or principle investigator • Inability to read and/or understand the Dutch language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Respicorder device measures standard spirometry (FEV1, FVC), IOS parameters and FeNO, which will be used for fluctuation analysis. The Asthma Control Questionnaire (ACQ) and Asthma Quality of Life Questionnaire (AQLQ) will be used to quantify asthma status. Patients will be evaluated by their treating clinician after 4 and 6 months of treatment with a biological. The outcome will be linked to the fluctuation patterns, such that can be evaluated whether these patterns can be used to predict a successful treatment with a biologic. | — |
Secondary
| Measure | Time frame |
|---|---|
| Spirometry, IOS and FeNO measurements with standard devices as done in standard care in the hospital will be used to compare with the Respicorder measurements. Subjects will also be asked about their experience with the Respicorder. | — |
Countries
Netherlands
Contacts
Public ContactA.T. Pelgröm
Amsterdam UMC
Outcome results
None listed