Bronchial Thermoplasty (BT) for Severe Asthma in the Biologic Era: a Randomized Controlled Trial (BOOSTER Trial)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Objective: To investigate the impact of BT as compared to standard of care in severe asthma patients that remain uncontrolled despite standard treatment including adequate doses of inhaled preventer therapies with or without biologics on: 1. rate of exacerbations 2. asthma related quality of life (AQLQ) 3. 1-year and 5-year cost-effectiveness and cost utility Study design: Investigator-initiated randomized, multicenter, parallel-group interventional RCT of severe asthma patients undergoing either BT (active arm) or standard care (control arm). Study population: Adult, uncontrolled severe asthma patients despite optimal medical therapy including one or more trials of treatment with a biologic or ineligible for biologic treatment AND 2 or more severe asthma exacerbations in the previous year AND FEV1 ≥ 50% predicted. Intervention: BT (active arm) versus standard care (control arm). Main study parameters/endpoints: The primary endpoint of this study is the between group difference in severe exacerbation rate after 12 months of follow-up. The main secondary endpoints are between group differences after 12 months of follow-up and within group differences before and after intervention or standard care. Parameters that will be explored are: AQLQ (minimal clinically important difference \>0.5), ACQ (minimal clinically important difference \>0.5), exacerbation rate (before and after BT) and hospitalizations (rate and % subjects).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
amsterdam UMC
RECRUITING
Amsterdam
UMCG
NOT_YET_RECRUITING
Groningen
Contact Information
Primary
P Bonta, Md PhD
p.i.bonta@amsterdamumc.nl
+31 (0)20-7329509
Time Frame
Start Date: 2024-04-09
Estimated Completion Date: 2029-04-30
Participants
Target number of participants: 90
Treatments
No_intervention: Usual care
Usual care for patient with severe asthma
Active_comparator: Intervention - Bronchial thermoplasty
Intervention with bronchial thermoplasty
Related Therapeutic Areas
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development

This content was sourced from clinicaltrials.gov