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Clinical Trials/NL-OMON56494
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)

Academisch Medisch Centrum0 sites48 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational non invasive

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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