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| Name | Class |
|---|---|
| University Medical Center Groningen | OTHER |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | measured yearly over 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | measured yearly over 5 years |
| provocative concentration causing a 20% fall (PC20 ) methacholine test |
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Inclusion Criteria:
Exclusion Criteria:
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All subjects who underwent BT treatment in the TASMA study (protocol No.NL45394.018.13) and were not lost to follow-up at the end of the 30 week pre-marked visit, and those willing to comply with the study protocol and routine visits for the duration of the study will be included. The expected number of patients included in the TASMA study is n=40. These are patients with severe asthma despite maximal asthma therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Peter Bonta, MD PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academisch Medisch Centrum | Amsterdam | North Holland | 1105 AZ | Netherlands |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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Two years after BT blood DNA/RNA will be retained
measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment |
| 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 | measured yearly over 5 years |
| Airway-resistance (sRaw) mechanics | measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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). | 2 years after inclusion, 2,5 years after BT |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |