title: Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial.
abstract: BACKGROUND
  Bronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure.
  
  
  METHODS
  Patients enrolled in the Asthma Intervention Research Trial were on inhaled corticosteroids ≥200 μg beclomethasone or equivalent + long-acting-beta2-agonists and demonstrated worsening of asthma on long-acting-β2-agonist withdrawal. Following initial evaluation at 1 year, subjects were invited to participate in a 4 year safety study. Adverse events (AEs) and spirometry data were used to assess long-term safety out to 5 years post-BT.
  
  
  RESULTS
  45 of 52 treated and 24 of 49 control group subjects participated in long-term follow-up of 5 years and 3 years respectively. The rate of respiratory adverse events (AEs/subject) was stable in years 2 to 5 following BT (1.2, 1.3, 1.2, and 1.1, respectively,). There was no increase in hospitalizations or emergency room visits for respiratory symptoms in Years 2, 3, 4, and 5 compared to Year 1. The FVC and FEV1 values showed no deterioration over the 5 year period in the BT group. Similar results were obtained for the Control group.
  
  
  CONCLUSIONS
  The absence of clinical complications (based on AE reporting) and the maintenance of stable lung function (no deterioration of FVC and FEV1) over a 5-year period post-BT in this group of patients with moderate to severe asthma support the long-term safety of the procedure out to 5 years.
authors.affiliation: Gartnavel General Hospital, University of Glasgow, Glasgow, UK. neil.thomson@glasgow.ac.uk
authors.forename: Neil C
authors.initials: NC
authors.lastname: Thomson
authors.forename: Adalberto S
authors.initials: AS
authors.lastname: Rubin
authors.forename: Robert M
authors.initials: RM
authors.lastname: Niven
authors.forename: Paul A
authors.initials: PA
authors.lastname: Corris
authors.forename: Hans Christian
authors.initials: HC
authors.lastname: Siersted
authors.forename: Ronald
authors.initials: R
authors.lastname: Olivenstein
authors.forename: Ian D
authors.initials: ID
authors.lastname: Pavord
authors.forename: David
authors.initials: D
authors.lastname: McCormack
authors.forename: Michel
authors.initials: M
authors.lastname: Laviolette
authors.forename: Narinder S
authors.initials: NS
authors.lastname: Shargill
authors.forename: Gerard
authors.initials: G
authors.lastname: Cox
mesh_terms: D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D058666:Adrenergic beta-2 Receptor Agonists / Q000627:therapeutic use; D000328:Adult; D001249:Asthma / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery*; D001999:Bronchoscopy / Q000009:adverse effects* / Q000379:methods*; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005541:Forced Expiratory Volume / Q000502:physiology; D006801:Humans; D008137:Longitudinal Studies; D008168:Lung / Q000503:physiopathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D009130:Muscle, Smooth / Q000503:physiopathology / Q000601:surgery*; D012720:Severity of Illness Index; D013147:Spirometry; D016896:Treatment Outcome; D014797:Vital Capacity / Q000502:physiology
chemical_list: D000305:Adrenal Cortex Hormones; D058666:Adrenergic beta-2 Receptor Agonists