Early detection of the effectiveness of treatment with biologicals in patients with severe asthma using fluctuation analysis of biomarkers

Conditions: Asthma
Asthma Bronchiale
10006436

Registration Number: NL-OMON56494

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 48

Inclusion Criteria

• Severe asthma based on the definition by the 2022 GINA guidelines.
• Will start treatment with a biological
• 18-60 years old
• 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

• 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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The Respicorder device measures standard spirometry (FEV1, FVC), IOS parameters<br /><br>and FeNO, which will be used for fluctuation analysis. The Asthma Control<br /><br>Questionnaire (ACQ) and Asthma Quality of Life Questionnaire (AQLQ) will be<br /><br>used to quantify asthma status. Patients will be evaluated by their treating<br /><br>clinician after 4 and 6 months of treatment with a biological. The outcome will<br /><br>be linked to the fluctuation patterns, such that can be evaluated whether these<br /><br>patterns can be used to predict a successful treatment with a biologic.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Spirometry, IOS and FeNO measurements with standard devices as done in standard<br /><br>care in the hospital will be used to compare with the Respicorder measurements.<br /><br>Subjects will also be asked about their experience with the Respicorder. </p><br>