What is this study trying to find out about severe asthma?

This study is evaluating how patients with severe asthma respond to biological therapies over three years. Researchers aim to identify clinical features and biomarkers that explain why some patients respond well while others do not. The study is part of a large European consortium focused on improving treatment understanding for autoimmune and allergic conditions.

Who may be eligible for this severe asthma clinical trial?

Adults with severe asthma needing high doses of inhaled corticosteroids plus other medications or oral steroids, as well as patients with mild to moderate controlled asthma and healthy volunteers, may be eligible. Participants must be able to give informed consent and meet specific treatment and health criteria. Please review eligibility criteria for more details.

Is there any cost to participate in this severe asthma clinical trial?

Study-related care, including all study visits and assessments, is provided at no cost. However, personal travel or other expenses related to participation may vary and are not guaranteed to be covered.

Actively Recruiting

All Genders

Healthy Volunteers

ID06126692

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

Research Sites

300 weeks

Total Duration

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 mildmoderate 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

All Genders

Healthy Volunteers

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

Research Team

Susanne Vijverberg, Dr.

Peter Bonta, MD

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