Ten year follow-up of subjects from 3 randomized controlled Bronchial Thermoplasty (BT) studies.

Completed

• Conditions: 10038716; Astma

• Registration Number: NL-OMON46716
• Lead Sponsor: Boston Scientific Cooperation International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 7

Inclusion Criteria

- Previously enrolled in AIR, RISA or AIR2
- Subjects who received active BT treatment and had last BT treatment at least 10 years follow-up
- Control/Sham subjects with at least 10 years of long-term follow-up

Exclusion Criteria

Severe asthma exacerbation or chest infection in the past 4 weeks

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>SAFETY:<br /><br>Absence of clinically significant post-treatment respiratory changes, following<br /><br>BT, defined as bronchiectasis or bronchial stenosis, as confirmed by Pulmonary<br /><br>HRCT scan at the BT 10+ study visit in those subjects who had a baseline HRCT<br /><br>scan in the AIR2 Study.<br /><br><br /><br>EFFECTIVENESS:<br /><br>Durability of the treatment effect by comparing the proportion of subjects who<br /><br>experience severe asthma exacerbations during the first and fifth years after<br /><br>BT treatment with the proportion of subjects who experience severe asthma<br /><br>exacerbations during the 12 month period prior to the BT 10+ study visit.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The following additional endpoints will be evaluated for the 12 month period<br /><br>prior to the BT 10+ study visit and will be compared to the first and fifth<br /><br>years after BT treatment:<br /><br>* Severe asthma exacerbation rates (exacerbations / subject / year)<br /><br>* Emergency room visits for respiratory adverse events (rates of emergency room<br /><br>visits and proportion of subjects with emergency room visits for respiratory<br /><br>adverse events)<br /><br>* Hospitalizations for respiratory adverse events (rates of hospitalizations<br /><br>and proportion of subjects with hospitalizations for respiratory adverse events)<br /><br>* Respiratory Serious Adverse Events (SAEs) (rates of respiratory SAEs, and<br /><br>proportion of subjects with respiratory SAEs)</p><br>