BACKGROUND:Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma. OBJECTIVE: We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy. METHODS:BT-treated subjects from the Asthma Intervention Research 2 trial (ClinicalTrials.govNCT01350414) were evaluated annually for 5 years to assess the long-term safety of BT and the durability of its treatment effect. Outcomes assessed after BT included severe exacerbations, adverse events, health care use, spirometric data, and high-resolution computed tomographic scans. RESULTS:One hundred sixty-two (85.3%) of 190 BT-treated subjects from the Asthma Intervention Research 2 trial completed 5 years of follow-up. The proportion of subjects experiencing severe exacerbations and emergency department (ED) visits and the rates of events in each of years 1 to 5 remained low and were less than those observed in the 12 months before BT treatment (average 5-year reduction in proportions: 44% for exacerbations and 78% for ED visits). Respiratory adverse events and respiratory-related hospitalizations remained unchanged in years 2 through 5 compared with the first year after BT. Prebronchodilator FEV₁ values remained stable between years 1 and 5 after BT, despite a 18% reduction in average daily inhaled corticosteroid dose. High-resolution computed tomographic scans from baseline to 5 years after BT showed no structural abnormalities that could be attributed to BT. CONCLUSIONS: These data demonstrate the 5-year durability of the benefits of BT with regard to both asthma control (based on maintained reduction in severe exacerbations and ED visits for respiratory symptoms) and safety. BT has become an important addition to our treatment armamentarium and should be considered for patients with severe persistent asthma who remain symptomatic despite taking inhaled corticosteroids and long-acting β₂-agonists.
RCT Entities:
BACKGROUND: Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma. OBJECTIVE: We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy. METHODS: BT-treated subjects from the Asthma Intervention Research 2 trial (ClinicalTrials.govNCT01350414) were evaluated annually for 5 years to assess the long-term safety of BT and the durability of its treatment effect. Outcomes assessed after BT included severe exacerbations, adverse events, health care use, spirometric data, and high-resolution computed tomographic scans. RESULTS: One hundred sixty-two (85.3%) of 190 BT-treated subjects from the Asthma Intervention Research 2 trial completed 5 years of follow-up. The proportion of subjects experiencing severe exacerbations and emergency department (ED) visits and the rates of events in each of years 1 to 5 remained low and were less than those observed in the 12 months before BT treatment (average 5-year reduction in proportions: 44% for exacerbations and 78% for ED visits). Respiratory adverse events and respiratory-related hospitalizations remained unchanged in years 2 through 5 compared with the first year after BT. Prebronchodilator FEV₁ values remained stable between years 1 and 5 after BT, despite a 18% reduction in average daily inhaled corticosteroid dose. High-resolution computed tomographic scans from baseline to 5 years after BT showed no structural abnormalities that could be attributed to BT. CONCLUSIONS: These data demonstrate the 5-year durability of the benefits of BT with regard to both asthma control (based on maintained reduction in severe exacerbations and ED visits for respiratory symptoms) and safety. BT has become an important addition to our treatment armamentarium and should be considered for patients with severe persistent asthma who remain symptomatic despite taking inhaled corticosteroids and long-acting β₂-agonists.
Authors: Ronald L Sorkness; Eugene R Bleecker; William W Busse; William J Calhoun; Mario Castro; Kian Fan Chung; Douglas Curran-Everett; Serpil C Erzurum; Benjamin M Gaston; Elliot Israel; Nizar N Jarjour; Wendy C Moore; Stephen P Peters; W Gerald Teague; Sally E Wenzel Journal: J Appl Physiol (1985) Date: 2007-11-08
Authors: Mario Castro; Adalberto Rubin; Michel Laviolette; Nicola A Hanania; Brian Armstrong; Gerard Cox Journal: Ann Allergy Asthma Immunol Date: 2011-04-14 Impact factor: 6.347
Authors: Ashley Busacker; John D Newell; Thomas Keefe; Eric A Hoffman; Janice Cook Granroth; Mario Castro; Sean Fain; Sally Wenzel Journal: Chest Date: 2008-08-08 Impact factor: 9.410
Authors: Mario Castro; Adalberto S Rubin; Michel Laviolette; Jussara Fiterman; Marina De Andrade Lima; Pallav L Shah; Elie Fiss; Ronald Olivenstein; Neil C Thomson; Robert M Niven; Ian D Pavord; Michael Simoff; David R Duhamel; Charlene McEvoy; Richard Barbers; Nicolaas H T Ten Hacken; Michael E Wechsler; Mark Holmes; Martin J Phillips; Serpil Erzurum; William Lunn; Elliot Israel; Nizar Jarjour; Monica Kraft; Narinder S Shargill; John Quiring; Scott M Berry; Gerard Cox Journal: Am J Respir Crit Care Med Date: 2009-10-08 Impact factor: 21.405
Authors: Ian D Pavord; Gerard Cox; Neil C Thomson; Adalberto S Rubin; Paul A Corris; Robert M Niven; Kian F Chung; Michel Laviolette Journal: Am J Respir Crit Care Med Date: 2007-09-27 Impact factor: 21.405
Authors: Sumit Gupta; Salman Siddiqui; Pranab Haldar; J Vimal Raj; James J Entwisle; Andrew J Wardlaw; Peter Bradding; Ian D Pavord; Ruth H Green; Christopher E Brightling Journal: Chest Date: 2009-06-19 Impact factor: 9.410
Authors: Neil C Thomson; Adalberto S Rubin; Robert M Niven; Paul A Corris; Hans Christian Siersted; Ronald Olivenstein; Ian D Pavord; David McCormack; Michel Laviolette; Narinder S Shargill; Gerard Cox Journal: BMC Pulm Med Date: 2011-02-11 Impact factor: 3.317
Authors: Bradley E Chipps; Robert S Zeiger; Alejandro Dorenbaum; Larry Borish; Sally E Wenzel; Dave P Miller; Mary Lou Hayden; Eugene R Bleecker; F Estelle R Simons; Stanley J Szefler; Scott T Weiss; Tmirah Haselkorn Journal: Curr Respir Care Rep Date: 2012-09-20
Authors: Alfons Torrego; Ivan Solà; Ana Maria Munoz; Marta Roqué I Figuls; Juan Jose Yepes-Nuñez; Pablo Alonso-Coello; Vicente Plaza Journal: Cochrane Database Syst Rev Date: 2014-03-03