3TR - ABC (Asthma Biologics Cohort) study and AIR-Bio-OCT study A part of the 3TR (Taxonomy, Treatment, Targets and Remission) Consortium for the identification of the molecular mechanisms of non-response to treatment, relapses, and remission in autoimmune, inflammatory, and allergic conditions - 3TR- ABC Study and AIR-Bio-OCT study

Amsterdam UMC0 sites75 target enrollmentStarted: TBDLast updated: June 18, 2024

Trial Snapshot

No summary available.

•Patients with severe asthma:
•Patients with the age of >=18 years diagnosed with severe asthma and eligible
•for biologic treatment (in the Netherlands the 3TR- ABC Study will include
•patients with severe asthma eligible for Anti-IgE, Anti-IL5(R), and
•Anti-IL4/IL13 treatment.).
•Patients are defined as having severe asthma if:
•* High dose treatment in the last year:
•o High dose ICS (corresponding to minimum 1600 micrograms Budesonide per day) +
•either LABA, LTRA, or LAMA
•o Fixed Prednisolone treatment (OCS) minimum 50% of the time.
•* Other reasons for lack of control excluded (systematic investigation
•according to guidelines for investigation of severe asthma)
•* Minimum 2 exacerbations in the last year or fixed Prednisolone treatment
•(OCS) minimum 50% of the time.
•Mild/moderate asthma controls:
•Patients of >=18 years with mild/moderate controlled asthma and markers of T2
•inflammation (see table 2) who are not candidates for biologic treatments.
•Healthy controls:
•Participants of >=18 years without any history of respiratory symptoms or recent
•infections, and who do not use any medication related to airway diseases or are
•in treatment for any other diseases that may influence respiratory biomarkers
•considerably.

•A potential subject who meets any of the following criteria will be excluded
•from participation in this study:
•Severe asthma patients will be excluded if:
•* Unable to understand written information due to language barriers.
•* Unable to give informed consent, i.e., patients who are incapable.
•* Unable to complete study visits.
•Mild/moderate asthma participants will be excluded if:
•* Unable to understand written information due to language barriers.
•* Unable to give informed consent, i.e., patients who are incapable.
•* Show signs of symptoms of uncontrolled asthma (ACQ score higher than 1.5, OCS
•use, history of exacerbations within the past year).
•Healthy participants will be excluded if:
•* Unable to understand written information due to language barriers.
•* Unable to give informed consent, i.e., patients who are incapable.

Sponsor

Amsterdam UMC