Actively Recruiting
3TR Asthma Biologics Cohort (ABC) Study - A Part of the 3TR Consortium for Identifying Molecular Mechanisms of Non-response, Relapses, and Remission in Autoimmune, Inflammatory, and Allergic Conditions
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2023-11-13
600
Participants Needed
2
Research Sites
300 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 large, multicenter observational research project that follows patients with severe asthma starting biological therapy and continues for three years. It aims to understand how patients respond to these treatments by examining clinical features, biomarkers, and immune system mechanisms. The study also includes healthy individuals and patients with mild to moderate controlled asthma as comparison groups to better understand differences in disease and treatment response. Participants with severe asthma who are beginning biological treatments will be assessed at the start of the study and then followed at set intervals: 4 weeks, 16 weeks, 52 weeks, 2 years, and 3 years. The study collects various biological samples for advanced analysis and uses innovative methods such as exhaled breath analysis and imaging technologies in specific sub-studies. The study design allows for additional visits if participants experience asthma exacerbations. Healthy volunteers and those with mild/moderate asthma only have a baseline visit. Throughout the study, participants undergo detailed clinical and biological evaluations including questionnaires, lung function tests, and biomarker sampling. The research team measures asthma control, lung function, frequency of exacerbations, and medication use over time. By tracking these outcomes and analyzing biological data, the study seeks to identify markers linked to treatment remission, response, or non-response. Safety and long-term effects are monitored during the three-year follow-up period.
CONDITIONS
Brief 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 (minimum 1600 micrograms Budesonide per day) plus either LABA, LTRA, or LAMA or fixed oral Prednisolone treatment at least 50% of the time
- Patients with at least 2 exacerbations in the last year or on fixed Prednisolone treatment at least 50% of the time or ACQ score above 1.5 and meeting national criteria for biological treatment
- Patients with mild to moderate asthma on low/medium dose ICS/LABA with or without LTRA, ACQ score below 1.5, no exacerbations or oral corticosteroid use in the last year, and markers of T2 inflammation
- Healthy volunteers with no history of respiratory diseases or asthma, normal lung function, no allergies, and no respiratory infections in the past 4 weeks
- Ability to provide informed consent
You will not qualify if you...
- Known allergy to active substances or excipients in patients with severe asthma
- Participation in interventional clinical trials or receipt of investigational drugs within 3 months prior to enrollment
- Other significant medical or uncontrolled diseases affecting participation
- For mild/moderate asthma patients: inability to understand written information or provide consent
- Signs of uncontrolled asthma in mild/moderate asthma patients, including ACQ score above 1.5, oral corticosteroid use, or recent exacerbations
- For healthy volunteers: inability to understand written information or provide consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 3 years
Participants with severe asthma starting biological therapy are followed with scheduled visits for clinical assessments and biomarker sampling over three years, including additional visits if they experience sudden exacerbations.
6 visits: baseline, 4 weeks, 16 weeks, 52 weeks, 2 years, and 3 years; additional visits for exacerbations as needed
Duration - Single visit
Participants with mild/moderate controlled asthma and healthy controls undergo a baseline visit for reference assessments only.
1 baseline visit (in-person)
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.
P
Peter Bonta, MD
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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