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Bronchial Thermoplasty for Adults With Severe Asthma in the Biologic Era

RecruitingNAAges 18 Years - anyAllAcademisch Medisch Centrum - Universiteit van Amsโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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 lon

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 50% predicted after 400ฮผg 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 โ‰ฅ35 * 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..
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What it tests

  • Bronchial thermoplasty
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Where

2 sites
amsterdam UMC
Amsterdam, Netherlands
UMCG
Groningen, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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