title: Safety of bronchial thermoplasty in patients with severe refractory asthma.
abstract: BACKGROUND
  Patients with severe refractory asthma treated with bronchial thermoplasty (BT), a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle, were followed up for 5 years to evaluate long-term safety of this procedure.
  
  
  OBJECTIVE
  To assess long-term safety of BT for 5 years.
  
  
  METHODS
  Patients with asthma aged 18 to 65 years requiring high-dose inhaled corticosteroids (ICSs) (>750 μg/d of fluticasone propionate or equivalent) and long-acting β2-agonists (LABAs) (at least 100 μg/d of salmeterol or equivalent), with or without oral prednisone (≤30 mg/d), leukotriene modifiers, theophylline, or other asthma controller medications were enrolled in the Research in Severe Asthma (RISA) Trial. Patients had a prebronchodilator forced expiratory volume in 1 second of 50% or more of predicted, demonstrated methacholine airway hyperresponsiveness, had uncontrolled symptoms despite taking maintenance medication, abstained from smoking for 1 year or greater, and had a smoking history of less than 10 pack-years.
  
  
  RESULTS
  Fourteen patients (of the 15 who received active treatment in the RISA Trial) participated in the long-term follow-up study for 5 years. The rate of respiratory adverse events (AEs per patient per year) was 1.4, 2.4, 1.7, and 2.4, respectively, in years 2 to 5 after BT. There was a decrease in hospitalizations and emergency department visits for respiratory symptoms in each of years 1, 2, 3, 4, and 5 compared with the year before BT treatment. Measures of lung function showed no deterioration for 5 years.
  
  
  CONCLUSIONS
  Our findings suggest that BT is safe for 5 years after BT in patients with severe refractory asthma.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00401986.
authors.affiliation: Glenfield General Hospital, University Hospitals of Leicester NHS Trust, Leicester, United Kingdom. Electronic address: ian.pavord@uhl-tr.nhs.uk.
authors.forename: Ian D
authors.initials: ID
authors.lastname: Pavord
authors.forename: Neil C
authors.initials: NC
authors.lastname: Thomson
authors.forename: Robert M
authors.initials: RM
authors.lastname: Niven
authors.forename: Paul A
authors.initials: PA
authors.lastname: Corris
authors.forename: Kian Fan
authors.initials: KF
authors.lastname: Chung
authors.forename: Gerard
authors.initials: G
authors.lastname: Cox
authors.forename: Brian
authors.initials: B
authors.lastname: Armstrong
authors.forename: Narinder S
authors.initials: NS
authors.lastname: Shargill
authors.forename: Michel
authors.initials: M
authors.lastname: Laviolette
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000031:analogs & derivatives / Q000627:therapeutic use; D000730:Androstadienes / Q000627:therapeutic use; D001249:Asthma / Q000628:therapy*; D001980:Bronchi; D001993:Bronchodilator Agents / Q000627:therapeutic use; D001999:Bronchoscopy / Q000009:adverse effects* / Q000379:methods*; D017115:Catheter Ablation; D005260:Female; D000068298:Fluticasone; D005500:Follow-Up Studies; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D016210:Methacholine Chloride; D008875:Middle Aged; D000068299:Salmeterol Xinafoate; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D000730:Androstadienes; D001993:Bronchodilator Agents; D016210:Methacholine Chloride; D000068299:Salmeterol Xinafoate; D000068298:Fluticasone; D000420:Albuterol