Status:
UNKNOWN
Fluctuation Analyses of Asthma Patients With Biologics Use
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Asthma
Eligibility:
All Genders
18-60 years
Brief Summary
The goal of this observational study is to compare the fluctuation patterns of biomarkers (Spirometry, FeNO, IOS) of responders and non-responders in asthma patients who will start treatment with a bi...
Detailed Description
SUMMARY Rationale: Treatment of patients with severe asthma has taken a new avenue with the introduction of biologics. Currently, treatment success with biologics may be around 75% and is determined ...
Eligibility Criteria
Inclusion
- In order to be eligible to participate in this study, a subject must meet all of the following 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
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- 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
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06024707
Start Date
December 1 2023
End Date
September 30 2024
Last Update
November 1 2023
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