Bronchial Thermoplasty 10+ Year Study

Boston Scientific

Status: Completed

Conditions: Asthma

Treatments: Other: Bronchial Thermoplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT03243292

92115848

Details and patient eligibility

About

To confirm the long-term efficacy and safety of Bronchial Thermoplasty (BT) at 10 years follow-up or beyond in subjects previously enrolled in any of the following Boston Scientific-sponsored, controlled pre-approval studies: AIR, RISA and AIR2.

Full description

Compare rates of severe asthma exacerbations of subjects during the first and fifth year after BT treatment with the proportion of subjects who experience severe asthma exacerbations during the 12 months period prior to enrollment.

Compare baseline HRCT scans from subjects from the AIR2 study that enroll in BT 10+ study to examine if there are any clinically significant post-treatment respiratory changes following BT defined as bronchiectasis or bronchial stenosis.

Enrollment: 192 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Subjects previously enrolled in AIR, RISA or AIR2
• Subjects who received active BT treatment and had last BT treatment at least 10 years and 6 weeks prior to enrollment
• Control/Sham subjects with at least 10 years of long-term follow-up from index date plus 6 weeks
• Subject is able to read, understand and sign a written Informed Consent to participate in the Study and able to comply with the study requirements

Exclusion Criteria:

• Severe asthma exacerbation or chest infection in the past 4 weeks. Subject entry into this study should be delayed until free from severe asthma exacerbation or chest infection for a minimum of 4 weeks.

Trial design

192 participants in 3 patient groups

Treated

Description:

Subjects that received Bronchial Thermoplasty in a prior study (AIR, RISA, or AIR2)

Treatment:

Other: Bronchial Thermoplasty

Control

Description:

Subjects that participated in prior study (AIR) or (RISA) but did not receive Bronchial Thermoplasty Treatment. Determine if the Control group of subjects asthma has progressed any different from those subjects treated with BT.

Treatment:

Other: Bronchial Thermoplasty

Sham

Description:

Subjects that participated in the AIR2 study, were blinded and did not receive the treatment. Determine if the Sham group of subjects asthma has progressed any different from those subjects treated with BT.

Treatment:

Other: Bronchial Thermoplasty