Bronchial Thermoplasty 10+ Year Study

Status:	Active, not recruiting
Conditions:	Asthma, Asthma
Therapuetic Areas:	Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	Any
Updated:	3/31/2019
Start Date:	December 11, 2017
End Date:	May 11, 2019

Ten Year Follow-up of Subjects From 3 Landmark Randomized Controlled Bronchial Thermoplasty (BT) Studies

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.

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.

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.

We found this trial at

sites

Washington University Medical Center

Saint Louis, Missouri 63110

Phone: 314-362-3010

from

Saint Louis, MO