Bronchial Thermoplasty for Adults With Severe Asthma in the Biologic Era

NCT07292805 | Recruiting DMC

• 1 other identifier: NL85642.018.23
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

Rationale: For patients with severe asthma that remain uncontrolled with exacerbations despite biologics or patients who are not eligible for biologics, there is no reimbursed treatment other than pulmonary rehabilitation in the Netherlands. Pulmonary rehabilitation is known to have a limited effect for a limited amount of time. Bronchial thermoplasty or bronchial ablation (BT) is a non-pharmacological treatment for asthma aiming to restore abnormal airway function by using an endobronchial approach. Previous RCT's reported efficacy on exacerbations and asthma related quality of life (AQLQ), but were performed before large availability of biologic treatments. Although a single BT treatment is not without costs, these costs seem to outweigh the costs that can be saved by the long-term (\>5 years) lowering effect of BT on the frequency of exacerbations and hospitalizations and omitting long term use of trials and switches of biologics. Therefore, the investigators hypothesize that BT, in the era of biologics, is superior (in terms of exacerbations and quality of life) over standard care and cost-effective in patients whose asthma remains uncontrolled despite optimal anti-inflammatory treatments including biologics, and the investigators propose to test this hypothesis in a RCT. 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. 1.rate of exacerbations
2. 2.asthma related quality of life (AQLQ)
3. 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).

Conditions

Asthma Exacerbations; Severe Asthma; Bronchial Thermoplasty

Keywords

bronchial thermoplasty; asthma; severe asthma; asthma exacerbations

Outcome Measures

Primary Outcomes (1)

• Exacerbation

  severe exacerbation rate after 12 months of follow-up

  12 months

Secondary Outcomes (7)

• Asthma related quality of life

  12 months

• Symptom burden

  12 months

• Emergency department visits

  12 months

• Hospitalizations

  12 months

• Maintenance OCS use

  12 months

Study Arms (2)

Usual care

NO INTERVENTION

Usual care for patient with severe asthma

Intervention - Bronchial thermoplasty

ACTIVE COMPARATOR

Intervention with bronchial thermoplasty

Procedure: Bronchial thermoplasty

Interventions

Bronchial thermoplasty PROCEDURE

Bronchial thermoplasty will be performed according to prior SOP's, in three sessions. First session RLL, second session LLL, third session RUL/LUL

Intervention - Bronchial thermoplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• or more trials of treatment with a biologic or ineligible for biologic treatment
• 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

You may not qualify if:

• chronic OCS therapy at a dose \>20 mg/day prednisone equivalent
• 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..

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (2)

amsterdam UMC

Amsterdam, Netherlands

RECRUITING

UMCG

Groningen, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Bronchial Thermoplasty

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Catheter Ablation; Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

P Bonta, Md PhD

CONTACT

+31 (0)20-7329509; p.i.bonta@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD, Principal Investigator

Model Details: Multicenter, randomized controlled trial

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: December 18, 2025
• Study Start: April 9, 2024
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

NL (2)