TASMA Extension Study: Long Term Efficacy and Safety of Bronchial Thermoplasty in Severe
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Emergency room visit for respiratory symptoms rate
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Emergency room visit for respiratory symptoms rate
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Fractional exhaled nitric oxide (FeNO)(measured yearly over 5 years)
- Rescue medication use(measured yearly over 5 years)
- Airway-resistance (sRaw) mechanics(measured yearly over 5 years)
- Asthma Quality of Life Questionnaire (AQLQ) scores(measured yearly over 5 years)
- Airway smooth muscle (ASM) mass(2 years after inclusion, 2,5 years after BT)
- Asthma Control Questionnaire (ACQ) scores(measured yearly over 5 years)
- Pre-and post bronchodilator forced expiratory volume at one second (FEV1) and related FEV1 % reversibility(measured yearly over 5 years)
- provocative concentration causing a 20% fall (PC20 ) methacholine test(measured yearly over 5 years)
- Airway-conductance(sGaw) mechanics(measured yearly over 5 years)
- forced oscillation technique (FOT)(measured over 5 years)
- Maintenance dose of oral steroids(measured yearly over 5 years)
- Maintenance dose of inhaled steroids(measured yearly over 5 years)
- optical coherence tomography (OCT) determined changes(2 years after inclusion, 2,5 years after BT)
Investigators
Prof J.T. Annema
Prof. Dr. J.T. Annema
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)