Observational study on severe asthma patients receiving biological therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The 3TR-ABC study is a multicenter observational cohort study that follows patients with severe asthma starting biological therapy for three years. It aims to assess treatment responses and examine clinical characteristics, biomarkers, and immunological mechanisms related to remission and non-response. Patients will be characterized at baseline and monitored with formal assessments at various intervals, allowing for stratification into remission, clinical responders, and non-responders based on their treatment response. The study is part of a larger consortium focused on advancing precision medicine in autoimmune and inflammatory diseases.

Why it matters

Who can join: the full rules

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.

Where it's running

• Bispebjerg Hospital
  Copenhagen, Denmark Recruiting
• Amsterdam University Medical Center
  Amsterdam, North Holland, Netherlands Recruiting

Study contacts

• Principal investigator: Anke-Hilse Maitland-van der Zee, Prof.Dr. — Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Study coordinator: Susanne Vijverberg, Dr.
• Email: s.j.vijverberg@amsterdamumc.nl
• Phone: 0031 (0)20-566 27 63

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.