Recent Developments In Bronchial Thermoplasty For Severe Asthma

Figures & data

Table 1 Key Eligibility Criteria For Bronchial Thermoplasty Used In Clinical Trials And In Clinical Practice

Criteria	Key Inclusion And Exclusion Criteria For Bronchial Thermoplasty Used In AIR2^Citation16 And RISA Trials^Citation15^a	Eligibility Criteria For Bronchial Thermoplasty Used In Clinical Practice From Selected Case Reports And Case Series
Age	Inclusion criteria: Adult; age 18–65 years.	Adult; age >65 years^Citation53,Citation60,Citation63
Current treatment	Inclusion criteria: Asthma requiring regular maintenance medications that includes inhaled corticosteroids (>1000 μg beclometasone per day or equivalent (AIR2 trial); >750 μg fluticasone propionate per day or equivalent (RISA trial)); and long-acting β2-agonist (≥100 μg salmeterol per day or equivalent), with or without other asthma medications. Oral corticosteroids at a dosage ≤ 10 mg per day (AIR2 trial) or ≤ 30 mg per day (RISA trial).	Oral corticosteroids at a dosage >10 mg per day^Citation33,Citation42,Citation57,Citation63,Citation71
Asthma Quality of Life Questionnaire (AQLQ) score	Inclusion criteria: Baseline AQLQ score 6.25 or lower.
Medical history	Exclusion criteria: chronic sinus disease (AIR2 trial), uncontrolled sinus disease (RISA trial); anticoagulants; use of immunosuppressants other than corticosteroids	Chronic sinus disease (PAS2 study)^Citation33
Smoking status	Inclusion criteria: Nonsmoker for 1 year or greater with a less than 10 pack-years smoking history.	Former smokers >10 pack-years total smoking history^Citation54 Current smoker, n=1^Citation60
Lung function	Inclusion criteria: pre-bronchodilator FEV1 ≥60% predicted (AIR2); FEV1 ≥50% predicted (RISA trial); Exclusion criteria: post-bronchodilator FEV1 <55% predicted (RISA trial); diffusing capacity (DLCO) <70% predicted (RISA trial)	Prebronchodilator FEV1 <60% predicted^Citation31,Citation35,Citation53,Citation58,Citation60^–^Citation63,Citation110
None of the following within the past 12 months	Exclusion criteria i. Three or more lower respiratory tract infections (AIR2 trial); in the last 3 months (RISA trial) ii. Four or more oral corticosteroid pulses for asthma exacerbation iii. Three or more hospitalizations for asthma
None of the following within the past 24 months	Exclusion criteria History of life-threatening asthma (history of intubation for asthma or intensive care unit admission for asthma)	History of life-threatening asthma^Citation63
Suitability to undergo bronchoscopy	Inclusion criteria Patient considered suitable for bronchoscopy

Note: ^aSimilar key exclusion criteria were used in the PAS2 study³³ and AIR2 trial¹⁶, except for chronic sinus disease, which was an exclusion criterion in AIR2.

Abbreviations: AIR, Asthma Intervention Research; DLCO, diffusing capacity of lung for carbon monoxide; PAS2, Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma; RISA, Research in Severe Asthma.

Figure 1 Algorithm to guide the selection of patients with severe refractory asthma for treatment with biologics and bronchial thermoplasty.

Note: ^aBiologics and bronchial thermoplasty are treatment options for patients with severe asthma (Step 5) who have uncontrolled asthma despite high-dose ICS plus long-acting β2-agonist and the long-acting muscarinic antagonist tiotropium and after assessment and management of causes of difficult-to-control asthma, such as nonadherence, poor inhaler technique, comorbidities, under treatment, and other behavioral factors.

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