3TR Asthma Biologics Cohort (ABC) 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
Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
SUMMARY
The 3TR-ABC study is a multicentre observational prospective cohort study platform that follows patients with severe asthma from the start of biological therapy and three years onwards. In the 3TR-ABC platform, individual studies are conducted on specific biologics, using aligned study designs. The aim of the study is to assess response to treatment and examine clinical characteristics, biomarkers, and immunological mechanisms related to response, including remission and non-response, that might be new targets or explanations for insufficient treatment. Patients will be extensively characterized at baseline and then followed throughout the years with formal clinical and biological assessment at 4, 16, 52 weeks, and 2, 3 years. Based on the response to treatment, patients will be stratified into remission, clinical responders, and non-responders, and pre-treatment biomarker profiles obtained at the baseline visit will be compared, as well as the immunological response to treatment. Healthy individuals and patients with mild/moderate controlled asthma are included as reference groups and will undergo the same baseline visit as patients with severe asthma. Several bio-samples, to perform multi-omic analysis, will be taken to examine biological pathways associated with response and non-response to biologics.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
View:
• Patients with severe asthma that requires High dose ICS (corresponding to minimum 1600 micrograms Budesonide per day) + either LABA, LTRA, or LAMA OR Fixed Prednisolone treatment (OCS) minimum 50% of the time. Minimum 2 exacerbations in the last year or fixed Prednisolone treatment (OCS) minimum 50% of the time OR ACQ\>1.5 AND Fulfils national criteria for specific biologic treatment.
• Patients with mild/moderate asthma that requires Low/Medium dose of ICS/LABA +/- LTRA. ACQ \< 1.5. No exacerbations in the last year or need of Prednisolone treatment (OCS). Markers of T2 inflammation (B-eos ≥ 0.15 actual or ≥ 0.30 the last year or Sputum eos ≥ 3%, FeNO ≥ 25, allergens positivity). Not direct candidate for treatments with monoclonal antibodies.
• Healthy volunteers that reports no respiratory diseases, No history of asthma or respiratory symptoms, normal lung function. No history of allergies. No lower or upper respiratory infections in the past 4 weeks.
Locations
Other Locations
Denmark
Bispebjerg Hospital
RECRUITING
Copenhagen
Netherlands
Amsterdam University Medical Center
RECRUITING
Amsterdam
Contact Information
Primary
Susanne Vijverberg, Dr.
s.j.vijverberg@amsterdamumc.nl
0031 (0)20-566 27 63
Backup
Peter Bonta, MD
p.i.bonta@amsterdamumc.nl
Time Frame
Start Date:2022-01-10
Estimated Completion Date:2033-08
Participants
Target number of participants:600
Treatments
Severe asthma anti-IL5/IL-5R starters (including Benralizumab cohort)
Patients with High dose ICS (corresponding to minimum 1600 micrograms Budesonide per day) + either LABA, LTRA, or LAMA OR Fixed Prednisolone treatment (OCS) minimum 50% of the time. Minimum 2 exacerbations in the last year or fixed Prednisolone treatment (OCS) minimum 50% of the time OR ACQ\>1.5 AND Fulfils national criteria for specific biologic treatment.
Severe asthma anti-IL4R starters
Patients with High dose ICS (corresponding to minimum 1600 micrograms Budesonide per day) + either LABA, LTRA, or LAMA OR Fixed Prednisolone treatment (OCS) minimum 50% of the time. Minimum 2 exacerbations in the last year or fixed Prednisolone treatment (OCS) minimum 50% of the time OR ACQ\>1.5 AND Fulfils national criteria for specific biologic treatment.
Severe asthma anti-TLSP starters
Patients with High dose ICS (corresponding to minimum 1600 micrograms Budesonide per day) + either LABA, LTRA, or LAMA OR Fixed Prednisolone treatment (OCS) minimum 50% of the time. Minimum 2 exacerbations in the last year or fixed Prednisolone treatment (OCS) minimum 50% of the time OR ACQ\>1.5 AND Fulfils national criteria for specific biologic treatment.
Severe asthma anti-IgE starters
Patients with High dose ICS (corresponding to minimum 1600 micrograms Budesonide per day) + either LABA, LTRA, or LAMA OR Fixed Prednisolone treatment (OCS) minimum 50% of the time. Minimum 2 exacerbations in the last year or fixed Prednisolone treatment (OCS) minimum 50% of the time OR ACQ\>1.5 AND Fulfils national criteria for specific biologic treatment.
Mild/moderate controlled asthma
Low/Medium dose of ICS/LABA +/- LTRA. ACQ \< 1.5. No exacerbations in the last year or need of Prednisolone treatment (OCS). Markers of T2 inflammation (B-eos ≥ 0.15 actual or ≥ 0.30 the last year or Sputum eos ≥ 3%, FeNO ≥ 25 ppb, allergens positivity). Not direct candidate for treatments with monoclonal antibodies.
Healthy controls
No history of respiratory diseases. No history of asthma or respiratory symptoms, normal lung function, no history of allergies. No lower or upper respiratory infections in the past 4 weeks.