Optical imaging techniques and breath analysis to evaluate the effect of Bronchial Thermoplasty (BT) for severe asthma

Recruiting

Conditions: Severe asthma
10038716

Registration Number: NL-OMON51801

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

1. Patient is an adult, aged 18 years or older, and is scheduled to undergo
(re-)BT treatment according to the Alair System directions for use, according
to the BT registry protocol.
2. Patient is able to read, understand, and sign a written IC to participate in
this study and able to comply with the registry requirements.
3. Patient meets the inclusion criteria of the BT registry

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:

1. Use of investigative drugs or intervention trials in the 4 months prior to
enrolment or during the duration of the study.
2. Any condition or compliance issue which in the opinion of the investigator
might interfere with participation in the study.
3. Any exclusion criteria from the BT-registry

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- To obtain visual qualitative remodeling characteristics and quantitative<br /><br>measurements of OCT airway images and their 3-D reconstructions before and<br /><br>after BT and the non-treated ML.<br /><br>- To obtain visual qualitative remodeling characteristics and quantitative<br /><br>measurements of ex-vivo HHGM images obtained from airway wall biopsies before<br /><br>and after BT and the non-treated ML.<br /><br>- To identify and quantify ASM, ECM and inflammatory components in OCT images.<br /><br>- To identify and quantify ASM, ECM and inflammatory components in HHGM images.<br /><br>- To correlate OCT and HHGM images with histology results.<br /><br>- To correlate OCT and HHGM images to clinical outcomes including responders /<br /><br>non - responders analysis<br /><br>- To identify and quantify changes in VOCs by eNose and/or GC-MS before and<br /><br>after BT and correlate this to omics approaches in blood (and brushes if<br /><br>available) .</p><br>

Secondary Outcome Measures