Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-01-28 @ 7:03 AM
Study NCT ID:
NCT02225392
Status:
COMPLETED
Last Update Posted:
2022-12-05
First Post:
2014-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Unravelling Targets of Therapy in Bronchial Thermoplasty in Severe Asthma
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Organization:
Study Overview
Official Title:
Unravelling Targets of Therapy in Bronchial Thermoplasty in Severe Asthma
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TASMA
Brief 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.
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: