RATIONALE: Bronchial thermoplasty (BT) is designed to reduce airway smooth muscle and improve asthma control. OBJECTIVES: This study was conducted to determine the safety and efficacy of this procedure in subjects with symptomatic, severe asthma. METHODS:Adults who were symptomatic despite treatment with fluticasone or equivalent at more than 750 mug/day, a long-acting beta(2)-agonist, and other medications, which could include 30 mg or less of oralprednisolone/day, were randomized to BT or to a control group. After treatment, subjects entered a 16-week steroid stable phase (Weeks 6-22), a 14-week steroid wean phase (Weeks 22-36), and a 16-week reduced steroid phase (Weeks 36-52). MEASUREMENTS AND MAIN RESULTS:BT resulted in a transient worsening of asthma symptoms. Seven hospitalizations for respiratory symptoms occurred in 4 of 15 BT subjects during the treatment period. Five hospitalizations were within 3 days of treatment. Two subjects had segmental collapse involving the most recently treated lobe; one required bronchoscopy and aspiration of a mucus plug. There were no hospitalizations during this period in the 17 control subjects. The rate of hospitalizations was similar in both groups in the post-treatment period. At 22 weeks, BT subjects had significant improvements versus control subjects in rescue medication use (-26.6 +/- 40.1 vs. -1.5 +/- 11.7 puffs/7 d, P < 0.05), prebronchodilator FEV(1)% predicted (14.9 +/- 17.4 vs. -0.94 +/- 22.3%, P = 0.04), and Asthma Control Questionnaire scores (-1.04 +/- 1.03 vs. -0.13 +/- 1.00, P = 0.02). Improvements in rescue medication use and Asthma ControlQuestionnaire scores remained significantly different from those of controls at 52 weeks. CONCLUSIONS:BT is associated with a short-term increase in asthma-related morbidity. However, there is preliminary evidence of long-lasting improvement in asthma control. Clinical trial registered with www.clinicaltrials.gov (NCT 00214539).
RCT Entities:
RATIONALE: Bronchial thermoplasty (BT) is designed to reduce airway smooth muscle and improve asthma control. OBJECTIVES: This study was conducted to determine the safety and efficacy of this procedure in subjects with symptomatic, severe asthma. METHODS: Adults who were symptomatic despite treatment with fluticasone or equivalent at more than 750 mug/day, a long-acting beta(2)-agonist, and other medications, which could include 30 mg or less of oral prednisolone/day, were randomized to BT or to a control group. After treatment, subjects entered a 16-week steroid stable phase (Weeks 6-22), a 14-week steroid wean phase (Weeks 22-36), and a 16-week reduced steroid phase (Weeks 36-52). MEASUREMENTS AND MAIN RESULTS: BT resulted in a transient worsening of asthma symptoms. Seven hospitalizations for respiratory symptoms occurred in 4 of 15 BT subjects during the treatment period. Five hospitalizations were within 3 days of treatment. Two subjects had segmental collapse involving the most recently treated lobe; one required bronchoscopy and aspiration of a mucus plug. There were no hospitalizations during this period in the 17 control subjects. The rate of hospitalizations was similar in both groups in the post-treatment period. At 22 weeks, BT subjects had significant improvements versus control subjects in rescue medication use (-26.6 +/- 40.1 vs. -1.5 +/- 11.7 puffs/7 d, P < 0.05), prebronchodilator FEV(1)% predicted (14.9 +/- 17.4 vs. -0.94 +/- 22.3%, P = 0.04), and Asthma Control Questionnaire scores (-1.04 +/- 1.03 vs. -0.13 +/- 1.00, P = 0.02). Improvements in rescue medication use and Asthma Control Questionnaire scores remained significantly different from those of controls at 52 weeks. CONCLUSIONS: BT is associated with a short-term increase in asthma-related morbidity. However, there is preliminary evidence of long-lasting improvement in asthma control. Clinical trial registered with www.clinicaltrials.gov (NCT 00214539).
Authors: Michael E Wechsler; Michel Laviolette; Adalberto S Rubin; Jussara Fiterman; Jose R Lapa e Silva; Pallav L Shah; Elie Fiss; Ronald Olivenstein; Neil C Thomson; Robert M Niven; Ian D Pavord; Michael Simoff; Jeff B Hales; Charlene McEvoy; Dirk-Jan Slebos; Mark Holmes; Martin J Phillips; Serpil C Erzurum; Nicola A Hanania; Kaharu Sumino; Monica Kraft; Gerard Cox; Daniel H Sterman; Kyle Hogarth; Joel N Kline; Adel H Mansur; Brian E Louie; William M Leeds; Richard G Barbers; John H M Austin; Narinder S Shargill; John Quiring; Brian Armstrong; Mario Castro Journal: J Allergy Clin Immunol Date: 2013-08-30 Impact factor: 10.793
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
Authors: Diana C Doeing; Amit K Mahajan; Steven R White; Edward T Naureckas; Jerry A Krishnan; Douglas K Hogarth Journal: J Asthma Date: 2012-12-20 Impact factor: 2.515
Authors: Elizabeth L Kramer; Elizabeth M Mushaben; Patricia A Pastura; Thomas H Acciani; Gail H Deutsch; Gurjit K Khurana Hershey; Thomas R Korfhagen; William D Hardie; Jeffrey A Whitsett; Timothy D Le Cras Journal: Am J Respir Cell Mol Biol Date: 2009-02-02 Impact factor: 6.914