Asthma Asthma
Conditions
Interventions
Not applicable. Observational study with invasive procedure.
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with severe asthmaPatients with the age of =18 years diagnosed with severe asthma and eligible for biological treatment.Patients are defined as having severe asthma if:High dose treatment in the last year:High dose ICS (corresponding to > 500ugr fluticasone) + either LABA, LTRA, or LAMA orAny fixed Prednisolone treatment (OCS) minimum 50% of the timeOther reasons for lack of control excluded (systematic investigation according to guidelines for investigation of severe asthma) andMinimum 2 exacerbations in the last year defined as course of steroids documented or patient-reported or fixed Prednisolone treatment (OCS) minimum 50% of the time,. or ACQ>1.5Clinical decision to initiate initiate biologic therapy for severe asthma after meeting licensing, local and national guidelines (Dupilumab, Mepolizumab, Benralizumab, Tezepelumab, Omalizumab or Reslizumab)Thus, in the Netherlands the 3TR- ABC Study will include patients with severe asthma eligible for any severe asthma biologic treatment.Mild/moderate asthma controls: Patients with the age of =18 years with mild/moderate controlled asthma and markers of T2 inflammation or T2 low inflammation (B-eos <0.15 actual or <0.30 the last year, sputum eos <3%, FeNO <25, allergens negative) who are not candidates for biologic treatments. Patients will be recruited at the Outpatient clinic of the Amsterdam UMC and/or the UMCG.Healthy controls:Participants with the age of =18 years without any history of respiratory symptoms or recent infections, and who do not use any medication related to airway diseases or are in treatment for any other diseases that may influence respiratory biomarkers considerably. Healthy subjects will be recruited among the accompanying persons of patients that access to the Outpatient clinic at either the Amsterdam UMC or UMCG.
Exclusion criteria
Exclusion criteria: Severe asthma patients will be excluded if:Unable to understand written information due to language barriers.Unable to give informed consent, i.e., patients who are incapable.Unable to complete study visits.Maintenance OCS (only an exclusion criterion for patients starting on Dupilumab as part of the Sanofi funded arm, not the overall 3TR).Not willing to contemplate / participate to the study protocol Exclusion criteria specifically for the AIR-BIO-OCT substudy patients:Patients have been treated with biologics for severe asthma <3 months before the inclusion.OCS use >20 mg daily.BMI >35.Have smoked > 15 pack years defined as (number of cigarettes smoked per day/20) × number of years smoked .Reports a diagnosis of EGPA, ABPA or other respiratory condition that interferes with BenralizumabMild/moderate asthma participants will be excluded if: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 participants will be excluded if:Unable to understand written information due to language barriers.Unable to give informed consent, i.e. patients who are incapable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine baseline biomarkers of remission after 1 year of biological therapy, defined as ACQ-5 <1.5, post-bronchodilator FEV1 percent predicted =80% OR >10% improvement as well as no exacerbations, or use of maintenance steroids for the past 12 months ("remission on treatment").Primary Objective:To identify and measure an eNose/ volatile organic compound (VOC)- multi-omics extensive severe asthma phenotyping strategy before treatment with biologicals to reveal add-on response characteristics to better predict treatment response.To identify and measure minimal invasive predicting "signature" of biological treatment response in severe eosinophilic asthma by extensive asthma pheno-endotyping using innovative minimal invasive exhaled breath technologies including eNose/VOCs and omics. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determine baseline biomarkers of remission after biological therapy. Additionally, i) Change in biomarker profiles in remission versus non-remission groups, ii) baseline and change in biomarker profile for a) each response outcome individually, b) Global evaluation treatment efficacy (GETE), patient and physician rated response, and c) 3TR agreed on a composite assessment of response, iii) determine the change in all response variables against baseline biomarker data and change in biomarkers as continuous variables. | — |
Countries
Netherlands
Contacts
Public ContactL Nicolai
Amsterdam UMC
Outcome results
None listed