Status:
RECRUITING
3TR Asthma Biologics Cohort (ABC) Study
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Bispebjerg Hospital
University Hospitals, Leicester
Conditions:
Severe Asthma
Eligibility:
All Genders
Brief 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...
Detailed Description
The 3TR Consortium is the overall generator behind the 3TR-ABC study. The 3TR Consortium consists of 15 European countries and a total of 69 partners who collaborate on seven different autoimmune, inf...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patients with severe asthma:
- Known hypersensitivity to the active substance or any of the excipients
- Participation in an interventional clinical trial within 3 months of visit 1 or receipt of any investigational medicinal product within 3 months or 5 half-lives. Participation in other observational studies is acceptable if in the view of the investigator it will not impact on the study outcomes.
- Other clinically significant medical disease or uncontrolled concomitant disease that is likely, in the opinion of the investigator, to require a change in therapy or impact the ability to participate in the study.
- Patients with mild/moderate asthma:
- Unable to understand written information due to language barriers.
- Unable to give informed consent, i.e., patients who are incapable.
- Show sign of symptoms of uncontrolled asthma (ACQ score higher than 1.5, OCS use, history of exacerbations within the past year).
- Healthy volunteers:
- Unable to understand written information due to language barriers.
- Unable to give informed consent, i.e., patients who are incapable.
Key Trial Info
Start Date :
January 10 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2033
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06126692
Start Date
January 10 2022
End Date
August 1 2033
Last Update
November 13 2023
Active Locations (2)
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1
Bispebjerg Hospital
Copenhagen, Denmark, 2400
2
Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands, 1105AZ