NCT02225392

Unravelling Targets of Therapy in Bronchial Thermoplasty in Severe Asthma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Approximately 5% of asthma patients suffer from severe asthma that is characterized by frequent asthma exacerbations resulting in significant morbidity and excessive utilisation of health care resources. Therefore, there is a strong need for improved therapeutic strategies for these patients. Insight in the pathogenesis and molecular pathways active in severe asthma is crucial to reach this goal. Bronchial Thermoplasty (BT) is a novel, innovative device-based treatment of severe asthma that is based on local, radiofrequent energy delivery in larger airways during bronchoscopy. Hypothesis: BT-induced clinical improvement in severe asthma is a consequence of reduction in airway smooth muscle (ASM) mass and (contractile/immunomodulatory) function, inflammation, neural innervation and/or vascular integrity resulting in altered airway remodelling. BT target identification and severe asthma phenotyping are critical for improved patient selection for BT and fundamental to discover novel, specific signalling pathways active in severe asthma.

Detailed description

This study has a two-fold purpose: 1. to unravel the targets of BT in severe asthma (how does it work?) which is fundamental for better patient selection (who benefits most?) and further improvement of BT technology and novel asthma therapy development (how to treat better?). These objectives can only be achieved by linking patient-reported outcomes to airway structure/function, which is the principal aim of the study proposed. 2. to investigate clinical outcome analyses

Conditions

• Asthma
• Bronchial Asthma

Interventions

Type	Name	Description
PROCEDURE	Bronchial thermoplasty	Bronchial thermoplasty (BT) will be performed using the Alair system (Boston Scientific, USA). Patients will undergo 3 bronchoscopy procedures with BT at least 3 weeks apart. Treatment sessions are designed to address different lobes of the lung with the right lower lobe treated during the first bronchoscopy, the left lower lobe treated during the second bronchoscopy, and both the right and left upper lobes treated in the third and final bronchoscopy. The right middle lobe and proximal airways including RC2 are left untreated.
DEVICE	Alair system (Boston Scientific, USA)	The alair system consist of a controller and a bastket catheter.

Timeline

• Start date: 2014-04-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2014-08-26
• Last updated: 2022-12-05

Locations

3 sites across 2 countries: Netherlands, United Kingdom