title: Long-term safety study of levalbuterol administered via metered-dose inhaler in patients with asthma.
abstract: BACKGROUND
  Previous studies have raised concerns regarding the safety of regular use of beta2-agonists for treating asthma. Few studies have explored the safety of at least 1 year of use of racemic albuterol, and none have examined long-term dosing of levalbuterol.
  
  
  OBJECTIVE
  To examine the long-term safety of levalbuterol hydrofluoroalkane (HFA) vs racemic albuterol HFA administered via metered-dose inhaler (MDI) in patients with stable asthma.
  
  
  METHODS
  Patients with mild to moderate asthma (mean forced expiratory volume in 1 second [FEVI], 68.3% of predicted) 12 years or older participated in a multicenter, parallel-group, open-label study. Patients were randomized to levalbuterol HFA MDI (90 microg; 2 actuations of 45 microg; n = 496) or racemic albuterol HFA MDI (180 microg; 2 actuations of 90 microg; n = 250) for 52 weeks of 4 times daily dosing. The primary end point was the incidence of postrandomization adverse events. Asthma exacerbations and pulmonary parameters were also assessed.
  
  
  RESULTS
  The overall incidence of adverse events was similar for levalbuterol (72.0%) and racemic albuterol (76.8%). Rates of beta-mediated adverse events, serious adverse events, and discontinuations because of adverse events were low (<15%) and were comparable between groups. Rates of asthma adverse events for levalbuterol and racemic albuterol were 18.3% and 19.6%, respectively. Mean percentage of predicted FEV1 improved after dosing and was stable for both groups.
  
  
  CONCLUSIONS
  In this trial, up to 52 weeks of regular use of levalbuterol HFA MDI or racemic albuterol HFA MDI was well tolerated, and no deterioration of lung function was detected during the study period.
authors.affiliation: Massachusetts General Hospital, Boston, Massachusetts, USA.
authors.forename: Daniel L
authors.initials: DL
authors.lastname: Hamilos
authors.forename: Anthony
authors.initials: A
authors.lastname: D'Urzo
authors.forename: Robin J
authors.initials: RJ
authors.lastname: Levy
authors.forename: Michael
authors.initials: M
authors.lastname: Marcus
authors.forename: Kenneth
authors.initials: K
authors.lastname: Tripp
authors.forename: Merdad
authors.initials: M
authors.lastname: Parsey
authors.forename: Rudolf A
authors.initials: RA
authors.lastname: Baumgartner
authors.forename: William K
authors.initials: WK
authors.lastname: McVicar
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000420:Albuterol / Q000008:administration & dosage* / Q000009:adverse effects; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D002648:Child; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers
chemical_list: D000318:Adrenergic beta-Agonists; D000420:Albuterol