TASMA Extension Study: Long Term Efficacy and Safety of Bronchial Thermoplasty in Severe Asthma.

Recruiting

• Conditions: asthma; asthmatic bronchitis; reversible airway obstruction; 10006436

• Registration Number: NL-OMON44139
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

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>