Bronchial thermoplasty for adults whose severe asthma isn't controlled by biologics

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

This trial will test whether bronchial thermoplasty helps adults with severe asthma who keep having exacerbations despite biologic treatments or who cannot take biologics.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other)
• Drugs / interventions: prednisone, Omalizumab, Reslizumab, Benralizumab, Mepolizumab, Dupilumab
• Locations: 2 sites (Amsterdam and 1 other locations)
• Trial ID: NCT07292805 on ClinicalTrials.gov

What this trial studies

This interventional study offers bronchial thermoplasty, an endobronchial ablation procedure intended to reduce airway smooth muscle and improve airway function, to adults with severe uncontrolled asthma. Eligible participants have persistent symptoms (ACQ >1.5), at least two severe exacerbations in the prior year, have tried a biologic or are ineligible for one, and have post-bronchodilator FEV1 ≥50% predicted. Key exclusions include high-dose chronic oral corticosteroid use (>20 mg/day prednisone equivalent), recent ICU intubation for asthma, pregnancy, high BMI, heavy smoking history, and reduced DLCOc. Participants will be treated at participating Dutch centers and followed for clinical outcomes including exacerbations, quality of life, lung function, and health care use.

Who should consider this trial

Good fit: Adults (≥18) with severe uncontrolled asthma despite optimal therapy, an ACQ >1.5, at least two severe exacerbations in the previous year, who have tried a biologic or are ineligible for biologic treatment, and have FEV1 ≥50% predicted after bronchodilator.

Not a fit: Patients on chronic high-dose oral corticosteroids (>20 mg/day), recent ICU intubation for asthma, pregnant people, those with BMI ≥35, heavy smokers (>20 pack-years), or DLCOc <70% are excluded and unlikely to benefit from this procedure.

Why it matters

Potential benefit: If successful, bronchial thermoplasty could lower exacerbation rates, reduce hospital visits and long-term steroid use, and improve quality of life for patients not helped by or ineligible for biologics.

How similar studies have performed: Randomized trials done before widespread biologic use showed BT reduced exacerbations and improved asthma-related quality of life, but experience in the current biologic era is limited.

Eligibility 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:

* chronic OCS therapy at a dose \>20 mg/day prednisone equivalent
* 1 or more ICU admission for mechanical or endotracheal intubation for
* asthma in the previous year.
* anti-coagulation therapy that cannot be stopped temporarily
* pregnancy
* body mass index ≥35
* current or ex-smokers with \>20 pack years
* DLCOc \<70%
* Subject has a known sensitivity to medications required to perform bronchoscopy
* Subject is using immunosuppressant therapy other than oral steroid therapy that impact on BT
* Subject has bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/mm2 or known coagulopathy
* Comorbidities that are a contra-indication for BT such as severe heart failure and other respiratory diseases including bronchiectasis, interstitial lung disease, emphy-sema, cystic fibrosis, mechanical upper airway obstruction, Churg-Strauss syndrome, and allergic bronchopulmonary aspergillosis (ABPA)
* Subject uses an internal or external pacemaker or cardiac defibrillator..

Where this trial is running

Amsterdam and 1 other locations

• amsterdam UMC — Amsterdam, Netherlands (RECRUITING)
• UMCG — Groningen, Netherlands (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: P Bonta, Md PhD

Conditions: Asthma Exacerbations, Severe Asthma, Bronchial Thermoplasty, bronchial thermoplasty, asthma, severe asthma, asthma exacerbations