Actively Recruiting
3TR Asthma Biologics Cohort (ABC) Study
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2023-11-13
600
Participants Needed
2
Research Sites
603 weeks
Total Duration
On this page
Sponsors
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
B
Bispebjerg Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
3TR Asthma Biologics Cohort (ABC) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with severe asthma requiring high dose inhaled corticosteroids plus LABA, LTRA, or LAMA, or fixed oral prednisolone treatment at least 50% of the time
- Patients with a minimum of 2 asthma exacerbations in the last year or oral prednisolone use at least 50% of the time
- Asthma Control Questionnaire (ACQ) score greater than 1.5
- Patients who meet national criteria for specific biologic treatment
- Patients with mild/moderate asthma requiring low/medium dose inhaled corticosteroids plus LABA with or without LTRA
- ACQ score less than 1.5 for mild/moderate asthma
- No exacerbations or need for oral prednisolone treatment in the last year for mild/moderate asthma
- Markers of type 2 inflammation (blood eosinophils ≥0.15 actual or ≥0.30 in last year, sputum eosinophils ≥3%, FeNO ≥25, or allergen positivity) for mild/moderate asthma
- Healthy volunteers with no respiratory diseases, no history of asthma or respiratory symptoms, normal lung function, no history of allergies, and no respiratory infections in the past 4 weeks
You will not qualify if you...
- Known hypersensitivity to the active substance or any excipients
- Participation in an interventional clinical trial or receipt of investigational medicinal product within 3 months or 5 half-lives prior to visit 1
- Other significant or uncontrolled medical diseases likely to affect therapy or study participation
- Unable to understand written information due to language barriers (mild/moderate asthma and healthy volunteers)
- Unable to provide informed consent (mild/moderate asthma and healthy volunteers)
- Signs of uncontrolled asthma including ACQ score higher than 1.5, oral corticosteroid use, or history of exacerbations within the past year (mild/moderate asthma)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Actively Recruiting
2
Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands, 1105AZ
Actively Recruiting
Research Team
S
Susanne Vijverberg, Dr.
CONTACT
P
Peter Bonta, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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