Yale-New Haven Hospital, Yale University School of Medicine, New Haven, CT, USA
Institut Universitaire de cardiologie et pneumonologie de Quebec, Université Laval, Quebec, QC, Canada.
Eur Respir J. 2017 Aug 31;50(2). doi: 10.1183/13993003.00017-2017. Print 2017 Aug.
Bronchial thermoplasty is an endoscopic therapy for severe asthma. The previously reported, randomised sham-controlled AIR2 (Asthma Intervention Research 2) trial showed a significant reduction in severe asthma exacerbations, emergency department visits and hospitalisations after bronchial thermoplasty. More "real-world" clinical outcome data is needed.This article compares outcomes in bronchial thermoplasty subjects with 3 years of follow-up from the ongoing, post-market PAS2 (Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma) study with those from the AIR2 trial.279 subjects were treated with bronchial thermoplasty in the PAS2 study. We compared the first 190 PAS2 subjects with the 190 bronchial thermoplasty-treated subjects in the AIR2 trial at 3 years of follow-up. The PAS2 subjects were older (mean age 45.9 40.7 years) and more obese (mean body mass index 32.5 29.3 kg·m) and took higher doses of inhaled corticosteroids (mean dose 2301 1961 μg·day). More PAS2 subjects had experienced severe exacerbations (74% 52%) and hospitalisations (15.3% 4.2%) in the 12 months prior to bronchial thermoplasty. At year 3 after bronchial thermoplasty, the percentage of PAS2 subjects with severe exacerbations, emergency department visits and hospitalisations significantly decreased by 45%, 55% and 40%, respectively, echoing the AIR2 results.The PAS2 study demonstrates similar improvements in asthma control after bronchial thermoplasty compared with the AIR2 trial despite enrolling subjects who may have had poorer asthma control.
支气管热成形术是一种治疗严重哮喘的内镜治疗方法。此前报道的随机、假对照 AIR2(哮喘干预研究 2)试验显示,支气管热成形术后严重哮喘加重、急诊就诊和住院的次数显著减少。需要更多的“真实世界”临床结果数据。本文比较了正在进行的、上市后 PAS2(支气管热成形术治疗严重持续性哮喘的 FDA 批准后临床试验)研究中具有 3 年随访结果的支气管热成形术受试者的结局,与 AIR2 试验中的结果进行比较。在 PAS2 研究中,279 例患者接受了支气管热成形术治疗。我们比较了 PAS2 研究中前 190 例患者和 AIR2 试验中支气管热成形术治疗的 190 例患者在 3 年随访时的结果。PAS2 组患者年龄较大(平均年龄 45.9 40.7 岁),更肥胖(平均体重指数 32.5 29.3 kg·m),吸入皮质激素剂量较高(平均剂量 2301 1961 μg·day)。更多的 PAS2 患者在支气管热成形术治疗前 12 个月经历了严重加重(74% 52%)和住院治疗(15.3% 4.2%)。在支气管热成形术后 3 年,PAS2 组患者严重加重、急诊就诊和住院的比例分别显著下降了 45%、55%和 40%,与 AIR2 试验结果一致。尽管 PAS2 研究纳入的患者可能控制较差,但研究结果表明,支气管热成形术治疗后哮喘控制情况也有类似的改善。