title: Albuterol multidose dry powder inhaler and albuterol hydrofluoroalkane versus placebo in children with persistent asthma.
abstract: BACKGROUND
  Many children struggle with albuterol hydrofluoroalkane (HFA) inhalers. Albuterol multidose dry powder inhaler (MDPI) may simplify rescue bronchodilator use in children.
  
  
  OBJECTIVE
  To demonstrate the comparability of albuterol MDPI and albuterol HFA in children with asthma.
  
  
  METHODS
  This phase II, multicenter, double-blind, double-dummy, single-dose, five-period, crossover study randomized patients (ages 4-11 years) with persistent asthma and prestudy forced expiratory volume in 1 second (FEV1) of 60-90% of predicted to 1 of 10 treatment sequences that contained albuterol MDPI (90 and 180 μg), albuterol HFA (90 and 180 μg), and placebo MDPI and placebo HFA. Efficacy was evaluated by measuring the area under the baseline-adjusted percent-predicted FEV1-time curve over 6 hours (PPFEV1 AUC0-6) after dosing. Safety was evaluated by adverse events.
  
  
  RESULTS
  The full analysis set included 61 patients. Albuterol MDPI and albuterol HFA significantly improved PPFEV1 AUC0-6 versus placebo (p ≤ 0.0107). Mean improvement (± standard error [SE]) in PPFEV1 AUC0-6 versus placebo with albuterol MDPI at 90 and 180 μg was similar (21.2 ± 4.87 [95% confidence interval {CI}, 11.60-30.81], and 22.6 ± 4.87 [95% CI, 13.00-32.20], %·hour, respectively). Mean improvement (± SE) with albuterol HFA 180 μg was significantly (p = 0.0226) greater versus albuterol HFA 90 μg (23.7 ± 4.85 [95% CI, 14.13-33.23], and 12.5 ± 4.85 [95% CI, 2.93-22.05], %·hour, respectively). All doses of albuterol were well tolerated.
  
  
  CONCLUSIONS
  Albuterol MDPI 90 and 180 μg and albuterol HFA 180 μg provided similar and significant FEV1 improvements versus placebo; albuterol HFA 90 μg was significant versus placebo but seemed less effective based on absolute improvements in FEV1. ClinicalTrials.gov identifier: NCT01899144.
authors.affiliation: Department of Pediatrics, Hoag Medical Group, Huntington Beach, California, USA.
authors.forename: Paul Y
authors.initials: PY
authors.lastname: Qaqundah
authors.forename: Herminia
authors.initials: H
authors.lastname: Taveras
authors.forename: Harald
authors.initials: H
authors.lastname: Iverson
authors.forename: Paul
authors.initials: P
authors.lastname: Shore
mesh_terms: D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage / Q000009:adverse effects; D000420:Albuterol / Q000008:administration & dosage* / Q000009:adverse effects; D001249:Asthma / Q000175:diagnosis / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D058995:Dry Powder Inhalers; D005260:Female; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers; D012129:Respiratory Function Tests; D016896:Treatment Outcome
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D001993:Bronchodilator Agents; D000420:Albuterol