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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• amsterdam UMC
  Amsterdam, Netherlands Recruiting
• Umcg
  Groningen, Netherlands Not yet recruiting

Study contacts

• Study coordinator: P Bonta, Md PhD
• Email: p.i.bonta@amsterdamumc.nl
• Phone: +31 (0)20-7329509

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.