Severe asthma
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To obtain visual qualitative remodeling characteristics and quantitative measurements of OCT airway images and their 3-D reconstructions before and after BT and the non-treated ML. - To obtain visual qualitative remodeling characteristics and quantitative measurements of ex-vivo HHGM images obtained from airway wall biopsies before and after BT and the non-treated ML. - To identify and quantify ASM, ECM and inflammatory components in OCT images. - To identify and quantify ASM, ECM and inflammatory components in HHGM images. - To correlate OCT and HHGM images with histology results. - To correlate OCT and HHGM images to clinical outcomes including responders / non - responders analysis - To identify and quantify changes in VOCs by eNose and/or GC-MS before and after BT and correlate this to omics approaches in blood (and brushes if available) . | — |
Secondary
| Measure | Time frame |
|---|---|
| - To validate the ASM measurements by OCT in a larger number of patients, as has been done before in our previous work. - To validate the distinctive patterns we have found in exhaled VOCs in responders and non-responders to BT with GC-MS in a larger number of patients. - To phenotype severe asthma and perform clinical outcome analyses that includes induced sputum, bronchial hyper-responsiveness (BHR, PC20 methacholine), forced expiratory volume in 1 second (FEV1) and fractional exhaled nitric oxide (FeNO) and molecular parameters including RNA-derived transcriptomes extracted from brushes. - To evaluate the sub-acute effects of BT from the collected data at the last BT bronchoscopy 6 weeks after the first treatment procedure (BT1). - To detect and evaluate the changes from measurements in the brushes and Bronchoalveolar lavage fluid (BALF) before and after therapy - To detect and evaluate the differences from measurements in the brushes and BALF between the responders and non-responders. - To evaluate the sub-acute effect of BT by analysing the biopsies, OCT measurements and HHGM images 6 weeks after treatment. | — |
Countries
Netherlands
Outcome results
None listed