Unraveling Targets of Therapy in Bronchial Thermoplasty in Severe Asthma (TASMA) Extension Study

TASMA Extension Study: Long Term Efficacy and Safety of Bronchial Thermoplasty in Severe

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02975284

Enrollment

Registered

2016-11-29

Start date

2015-08-31

Completion date

2024-09-30

Last updated

2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Asthma

Keywords

bronchial thermoplasty, long term, interventional bronchoscopy

Brief summary

This study evaluates the longterm clinical outcomes, including safety and efficacy parameters after Bronchial Thermoplasty (BT) treatment over a period of 5 years. All patients included in de TASMA trial in the Netherlands will be asked to participate in the TASMA extension study.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Subject participation in the TASMA study * Ability and willingness to provide informed consent. * Ability to comply with the study protocol

Exclusion criteria

* Subject participating in another clinical trial involving respiratory intervention which in the opinion of the investigator might interfere with the study.

Design outcomes

Primary

Measure	Time frame	Description
Severe exacerbations rate	measured yearly over 5 years	exacerbations / subject / year measured yearly over 5 years will be compared to the health care utilization pre- and 6 months post BT-treatment.
Emergency room visit for respiratory symptoms rate	measured yearly over 5 years	emergency room visits for respiratory symptoms/subject/year measured yearly over 5 years will be compared to the health care utilization pre- and 6 months post BT-treatment.
Hospitalization for respiratory symptoms rate	measured yearly over 5 years	hospitalizations for respiratory symptoms/subject/year measured yearly over 5 years will be compared to the health care utilization pre- and 6 months post BT-treatment.

Secondary

Measure	Time frame	Description
Airway-resistance (sRaw) mechanics	measured yearly over 5 years	measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Airway-conductance(sGaw) mechanics	measured yearly over 5 years	measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
forced oscillation technique (FOT)	measured over 5 years	measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Asthma Control Questionnaire (ACQ) scores	measured yearly over 5 years	measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Asthma Quality of Life Questionnaire (AQLQ) scores	measured yearly over 5 years	measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Pre-and post bronchodilator forced expiratory volume at one second (FEV1) and related FEV1 % reversibility	measured yearly over 5 years	measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Maintenance dose of inhaled steroids	measured yearly over 5 years	measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Rescue medication use	measured yearly over 5 years	measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Airway smooth muscle (ASM) mass	2 years after inclusion, 2,5 years after BT	ASM mass as determined by percentage/absolute ASM surface area and distance of reticular basement membrane (RBM) to ASM layer in endobronchial biopsies
optical coherence tomography (OCT) determined changes	2 years after inclusion, 2,5 years after BT	OCT determined changes in structural airway remodelling as measured by changes in lumen area (Ai) and airway wall thickness (Aaw).
Maintenance dose of oral steroids	measured yearly over 5 years	measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
provocative concentration causing a 20% fall (PC20 ) methacholine test	measured yearly over 5 years	measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Fractional exhaled nitric oxide (FeNO)	measured yearly over 5 years	measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment

Countries

Netherlands

Outcome results