Unravelling Targets of Therapy in Bronchial Thermoplasty in Severe Asthma

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.

Conditions

• Asthma
• Bronchial Asthma

Interventions

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.

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• The Netherlands Asthma Foundation

  collaborator OTHER

• Boston Scientific Corporation

  collaborator INDUSTRY

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  lead OTHER

Principal Investigators

• Jouke T Annema, Prof. Dr. · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

• P I Bonta, Dr · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-04-30

Primary Completion

2019-12-31

Completion

2019-12-31

Countries

• Netherlands
• United Kingdom

Study Locations