TASMA Extension Study: Long Term Efficacy and Safety of Bronchial Thermoplasty in Severe Asthma.
Recruiting
- Conditions
- asthmaasthmatic bronchitisreversible airway obstruction10006436
- Registration Number
- NL-OMON44139
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 35
Inclusion Criteria
participation in the TASMA study
Exclusion Criteria
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 invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint is the health care utilization ( Emergency room visits,<br /><br>Hospitalizations, Severe exacerbations rate) measured yearly over 5 years and<br /><br>compared to the pre- and post BT-treatment. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are the following parameters measured over 5 years compared<br /><br>to the parameters measured pre- and post-BT treatment:<br /><br>1). Clinical outcome parameters, including ACQ/ AQLQ scores, health care<br /><br>utilization ( Emergency room visits, Hospitalizations, Severe exacerbations<br /><br>rate), medication, pulmonary function test (PC20 methacholine, pre- and post<br /><br>bronchodilator FEV1 and FEV1 % revesibility, FeNO, Airway-resistance<br /><br>(sRaw)/-conductance(sGaw)/-mechanics (forced oscillation technique (FOT))<br /><br><br /><br>Optional only for AMC / UMCG recruited patients:<br /><br>2). ASM mass as determined by percentage/absolute ASM surface area and distance<br /><br>of reticular basement membrane (RBM) to ASM layer in endobronchial biopsies.<br /><br><br /><br>3). OCT determined changes in structural airway remodelling as measured by<br /><br>changes in lumen area (Ai) and airway wall thickness (Aaw).</p><br>