Bronchial thermoplasty (BT) for severe asthma in the biologic era: a randomized controlled trial (BOOSTER trial)

Conditions: 10006436
asthmatic bronchitis
asthma

Registration Number: NL-OMON56716

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 90

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

-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 <70%
-Subject uses an internal or external pacemaker or cardiac defibrillator

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Between group difference in severe exacerbation rate after 12 months of<br /><br>follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Between and before and after group differences after follow-up of (6 and) 12<br /><br>months in:<br /><br>- AQLQ<br /><br>- ACQ<br /><br>- Exacerbation rate<br /><br>- Time to first severe exacerbation<br /><br>- % subjects with severe exacerbation<br /><br>- Emergency department visits (rate and % subjects)<br /><br>- Hospitalizations (rate and % subjects)<br /><br>- % subjects with OCS reduction 50% or more<br /><br>- % subjects with biologics stop<br /><br>- Pulmonary function testing (FEV1, FEV1 reversibility, PC20 if available)<br /><br>- Asthma control biomarkers (FENO, blood eosinophils)<br /><br>- Adverse events from BT<br /><br>- EQ-5D-5<br /><br>- Costs (including Productivity Costs Questionnaire (PCQ)<br /><br>- SAQ (optional)</p><br>