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36  Bronchial Thermoplasty

 

635

 

 

 

Table 36.1  Bronchial thermoplasty trial l

 

 

 

 

 

 

Study

Study design

Patients, N

Outcomes

AIR [10]

Prospective RCT

112

Primary end point:

 

 

 

• Reduction in exacerbation rates

 

 

 

Secondary end points:

 

 

 

• Improvement in ACQ and AQLQ

 

 

 

• Five-year follow-up: Stable FEV1; stable long-term

 

 

 

safety pro le

RISA [12]

Prospective RCT

32

Primary end point:

 

 

 

• Safety and ef cacy: short-term increase in

 

 

 

hospitalizations due to asthma symptoms

 

 

 

post-procedure

 

 

 

Secondary end points:

 

 

 

• ACQ and decrease in rescue medication use

 

 

 

• Five-year follow-up: Stable FEV1; reduction in

 

 

 

hospitalizations and ER visits

 

 

 

 

AIR2 [13]

Randomized, double-

288

Primary end point:

 

blind, sham controlled

 

• Improvement in AQLQ

 

 

 

Secondary endpoint:

 

 

 

• Reduction in sever exacerbations, ER visits,

 

 

 

and days missed from school/work in 12 months

 

 

 

• Five-year follow-up: Stable FEV1; persistent

 

 

 

reduction in severe exacerbation and ER visits

PAS2 [14]

Post-FDA approval

190

Stable FEV1; persistent decrease in severe

 

study; three-year

 

exacerbations, ER visits, and hospitalization due

 

follow-up of patients

 

to asthma

 

from AIR2 trial

 

 

BT10+ study [4]

Ten-year follow-up

192

FEV1 stable; similar quality of life measures; similar

 

from AIR, RISA, AIR2

 

proportions of severe exacerbations at one, ve, and

 

 

 

ten years (24%, 22%, and 25%, respectively)

 

 

 

 

ACQ Asthma Control Questionnaire, AIR Asthma Intervention Research, AQLQ Asthma Quality of Life Questionnaire, ER, FDA, FEV1, PAS2 post-FDA approval study, RISA Research in Severe Asthma, RCT randomized controlled trial

Patient Selection

Eligibility guidelines are based on the inclusion criteria used in the AIR2 and RISA trials [12, 13]. All patients should be rigorously screened. BT is used for patients with severe refractory asthma despite optimal medical maintenance therapy, including biologics [2]. First and foremost, con-rmation of the correct diagnosis/criteria of severe asthma as de ned by American Thoracic Society/European Respiratory Society (ATS/ ERS) guidelines should be done despite adher-

ence to high-dose ICS and LABA and possible biologics. All patients should be evaluated and treated for contributing factors like environmental triggers (occupational exposures, allergens) and comorbidities (gastroesophageal refux, postnasal drip, obstructive sleep apnea (OSA), vocal cord dysfunction) [2, 11]. Contraindications to BT should be assessed before the procedure (implantable electronic devices such as a pacemaker and/or de brillator, prior BT treatment, tracheal stenosis). See Table 36.2 for inclusion and exclusion criteria.

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