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

Active, not recruiting

• Conditions: Severe Asthma

• Registration Number: NCT02975284
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-11-21
• Study First Submitted QC: 2016-11-23
• Study First Posted: 2016-11-29
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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
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-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
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
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
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
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
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
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
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
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
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).

Trial Locations

Locations (1)

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Noord Holland, Netherlands