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 Type
OBSERVATIONAL
Enrollment
30
Academisch Medisch Centrum
Amsterdam, North Holland, Netherlands
Severe exacerbations rate
exacerbations / subject / year measured yearly over 5 years will be compared to the health care utilization pre- and 6 months post BT-treatment.
Time frame: measured yearly over 5 years
Emergency room visit for respiratory symptoms rate
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.
Time frame: measured yearly over 5 years
Hospitalization for respiratory symptoms rate
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.
Time frame: 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 compared to the parameters measured pre- and 6 months post-BT treatment
Time frame: measured yearly over 5 years
provocative concentration causing a 20% fall (PC20 ) methacholine test
measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Time frame: measured yearly over 5 years
Fractional exhaled nitric oxide (FeNO)
measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Time frame: measured yearly over 5 years
Airway-resistance (sRaw) mechanics
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measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Time frame: measured yearly over 5 years
Airway-conductance(sGaw) mechanics
measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Time frame: measured yearly over 5 years
forced oscillation technique (FOT)
measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Time frame: measured over 5 years
Asthma Control Questionnaire (ACQ) scores
measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Time frame: measured yearly over 5 years
Asthma Quality of Life Questionnaire (AQLQ) scores
measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Time frame: measured yearly over 5 years
Maintenance dose of oral steroids
measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Time frame: measured yearly over 5 years
Maintenance dose of inhaled steroids
measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Time frame: measured yearly over 5 years
Rescue medication use
measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
Time frame: measured yearly over 5 years
Airway smooth muscle (ASM) mass
ASM mass as determined by percentage/absolute ASM surface area and distance of reticular basement membrane (RBM) to ASM layer in endobronchial biopsies
Time frame: 2 years after inclusion, 2,5 years after BT
optical coherence tomography (OCT) determined changes
OCT determined changes in structural airway remodelling as measured by changes in lumen area (Ai) and airway wall thickness (Aaw).
Time frame: 2 years after inclusion, 2,5 years after BT