NL-OMON56494
Not Yet Recruiting
N/A
Early detection of the effectiveness of treatment with biologicals in patients with severe asthma using fluctuation analysis of biomarkers - FABLE (Fluctuation analysis in asthma and biologics use)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 48
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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