title: Twelve- and 52-week safety of albuterol multidose dry powder inhaler in patients with persistent asthma.
abstract: OBJECTIVE
  Evaluate the safety of albuterol multidose dry powder inhaler (MDPI), a novel, inhalation-driven device that does not require coordination of actuation with inhalation, in patients with persistent asthma.
  
  
  METHODS
  We report pooled safety data from two 12-week, multicenter, randomized, double-blind, repeat-dose, parallel-group studies and the 12-week double-blind phase of a 52-week multicenter safety study as well as safety data from the 40-week open-label phase of the 52-week safety study. In each study, eligible patients aged ≥ 12 years with persistent asthma received placebo MDPI or albuterol MDPI 180 µg (2 inhalations × 90 µg/inhalation) 4 times/day for 12 weeks. In the 40-week open-label phase of the 52-week safety study, patients received albuterol MDPI 180 μg (2 inhalations × 90 μg/inhalation) as needed (PRN).
  
  
  RESULTS
  During both 12-week studies and the 12-week double-blind phase of the 52-week study, adverse events were more common with placebo MDPI (50%; n = 333) than albuterol MDPI (40%; n = 321); most frequent were upper respiratory tract infection (placebo MDPI 11%, albuterol MDPI 10%), nasopharyngitis (6%, 5%), and headache (6%, 4%). Incidences of β2-agonist-related events (excluding headache) during the pooled 12-week dosing periods were low (≤ 1%) in both groups. The safety profile with albuterol MDPI PRN during the 40-week open-label phase [most frequent adverse events: nasopharyngitis (12%), sinusitis (11%), upper respiratory tract infection (9%)] was similar to that observed during the 12-week pooled analysis.
  
  
  CONCLUSIONS
  The safety profile of albuterol MDPI 180 μg in these studies was comparable with placebo MDPI and consistent with the well-characterized profile of albuterol in patients with asthma.
authors.affiliation: a Bethesda Allergy Asthma and Research Center , LLC , Bethesda , MD , USA .
authors.forename: Gordon
authors.initials: G
authors.lastname: Raphael
authors.affiliation: b Teva Pharmaceuticals , Miami , FL , USA and.
authors.forename: Herminia
authors.initials: H
authors.lastname: Taveras
authors.affiliation: b Teva Pharmaceuticals , Miami , FL , USA and.
authors.forename: Harald
authors.initials: H
authors.lastname: Iverson
authors.affiliation: b Teva Pharmaceuticals , Miami , FL , USA and.
authors.forename: Christopher
authors.initials: C
authors.lastname: O'Brien
authors.affiliation: c Northeast Medical Research Associates , North Dartmouth , MA , USA.
authors.forename: David
authors.initials: D
authors.lastname: Miller
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D004311:Double-Blind Method; D058995:Dry Powder Inhalers; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D001993:Bronchodilator Agents; D000420:Albuterol
keywords: Albuterol; asthma; dry powder inhaler; inhalation device; safety