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 platform, individual studies are conducted on specific biologics, using aligned study designs. The aim of the study is to assess response to treatment and examine clinical characteristics, biomarkers, and immunological mechanisms related to response, including remission and non-response, that might be new targets or explanations for insufficient treatment. Patients will be extensively characterized at baseline and then followed throughout the years with formal clinical and biological assessment at 4, 16, 52 weeks, and 2, 3 years. Based on the response to treatment, patients will be stratified into remission, clinical responders, and non-responders, and pre-treatment biomarker profiles obtained at the baseline visit will be compared, as well as the immunological response to treatment. Healthy individuals and patients with mild/moderate controlled asthma are included as reference groups and will undergo the same baseline visit as patients with severe asthma. Several bio-samples, to perform multi-omic analysis, will be taken to examine biological pathways associated with response and non-response to biologics.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Change in Asthma Control Questionnaire 5 (ACQ-5) score — 1 year, 2 and 3 years This is a validated score that includes 5 questions scored from 0 to 6 with the total score being the average of the questions. The ACQ score ranges between 0 (well controlled) and 6 (extremely poorly controlled). A score of 1.5 or more indicates that a patient has inadequate asthma control.
Change in post- broncodilator Forced Expiratory Volume after 1 second (FEV1) — 1 year, 2 and 3 years This is a validated parameter, part of regular clinical care, to assess airway obstruction using a spirometry. A dose of bronchodilator medication is administered by means of inhaler or nebulizer (such as 400mcg of salbutamol). and the spirometry is repeated after 15 minutes. An increase of the FEV1 \>10% compared to the baseline or a FEV1 ≥80% indicates good asthma control
Absense of exacerbations — 1 year, 2 and 3 years Asthma exacerbations are acute or subacute episodes of progressively worsening shortness of breath, cough, wheezing, and chest tightness-or some combination of these symptoms.
No usage of oral corticosteroids in the previous 12 months — 1 year, 2 and 3 years Oral corticosteroids (OCS) are a common treatment for acute asthma flare-ups to reduce inflammation and swelling in the airways. Severe asthma patients can be oral corticosteroids dependent and the reduction of the usage of oral corticosteroids will indicate a good asthma control.
Trial sites (2)
Facility
City
Region
Status
Bispebjerg Hospital
Copenhagen
Denmark
Recruiting
Amsterdam University Medical Center
Amsterdam
North Holland
Recruiting
More Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) trials in Denmark
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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