asthma asthmatic bronchitis asthma
Conditions
Interventions
BT (active arm) versus standard care (control arm).
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -adult (>18 years) -severe uncontrolled asthma (defined as ACQ above 1.5) despite optimal medical therapy (GINA treatment step 5; alternative diseases excluded, therapy compliance and adequate inhalation technique confirmed) -1 or more trials of treatment with a biologic or ineligible for biologic treatment -2 or more severe asthma exacerbations in the previous year (defined as the need for a course of OCS or doubling dose of maintenance OCS for at least 3 consecutive days) -FEV1 >= 50% predicted after 400µg inhaled salbutamol or equivalent
Exclusion criteria
Exclusion criteria: -chronic OCS therapy at a dose >20 mg/day prednisone equivalent; -anti-coagulation therapy that cannot be stopped temporarily -comorbidities that are a contra-indication for BT (e.g. bronchiectasis, heart failure) -pregnancy; -body mass index >=35; -current or ex-smokers with >20 pack years; -DLCOc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Between group difference in severe exacerbation rate after 12 months of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Between and before and after group differences after follow-up of (6 and) 12 months in: - AQLQ - ACQ - Exacerbation rate - Time to first severe exacerbation - % subjects with severe exacerbation - Emergency department visits (rate and % subjects) - Hospitalizations (rate and % subjects) - % subjects with OCS reduction 50% or more - % subjects with biologics stop - Pulmonary function testing (FEV1, FEV1 reversibility, PC20 if available) - Asthma control biomarkers (FENO, blood eosinophils) - Adverse events from BT - EQ-5D-5 - Costs (including Productivity Costs Questionnaire (PCQ) - SAQ (optional) | — |
Countries
Netherlands
Contacts
Public ContactL Nicolai
Amsterdam UMC
Outcome results
None listed