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 Criteria:

  • 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 Criteria:

  • Patients with severe asthma:

    1. Known hypersensitivity to the active substance or any of the excipients
    2. 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.
    3. 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:

    1. Unable to understand written information due to language barriers.
    2. Unable to give informed consent, i.e., patients who are incapable.
    3. Show sign of symptoms of uncontrolled asthma (ACQ score higher than 1.5, OCS use, history of exacerbations within the past year).
  • Healthy volunteers:

    1. Unable to understand written information due to language barriers.
    2. 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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Page 1 of 1 (2 locations)

1

Bispebjerg Hospital

Copenhagen, Denmark, 2400

2

Amsterdam University Medical Center

Amsterdam, North Holland, Netherlands, 1105AZ

3TR Asthma Biologics Cohort (ABC) Study | DecenTrialz