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
- Conditions
- severe asthmauncontrolled asthma10024967
- Registration Number
- NL-OMON52133
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 75
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
or
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)
and
* 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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>3TR-ABC:<br /><br>To determine super responders, clinical responders, and non-responders of the<br /><br>real-life severe asthma cohort.<br /><br><br /><br>AIR Bio-OCT:<br /><br>Establish minimal invasive prediction 'signatures' for Benralizumab response in<br /><br>severe asthma by multilevel non-invasive exhaled breath -omics approach.<br /><br></p><br>
- Secondary Outcome Measures
Name Time Method <p>3TR-ABC:<br /><br>To identify and describe differences in biomarker profiles between super<br /><br>responders, clinical responders, and non-responders.<br /><br><br /><br>AIR Bio-OCT Study<br /><br>Establish a change in extra cellular matrix (ECM) and airway smooth muscle mass<br /><br>(ASM) by standard - PS-OCT and endobronchial biopsy analysis after 52 weeks of<br /><br>Benralizumab treatment (15 patients).</p><br>