title: Novel albuterol multidose dry powder inhaler in patients with exercise-induced bronchoconstriction: A single-dose, double-blind, randomized, 2-way crossover study.
abstract: BACKGROUND
  A novel, inhalation-driven, multidose dry powder inhaler (MDPI) was developed that eliminates the need to coordinate device actuation with inhalation as is required with conventional metered-dose inhalers.
  
  
  OBJECTIVE
  To evaluate albuterol MDPI efficacy and safety in patients with exercise-induced bronchoconstriction (EIB).
  
  
  METHODS
  This single-dose, double-blind, 2-way crossover study randomized adolescents and adults with EIB (≥20% fall from pre-exercise challenge FEV(1)) to treatment sequences of albuterol MDPI (180 μg [2 inhalations of 90 μg each])/placebo MDPI (n = 19) or the reverse sequence (n = 19). FEV(1) was measured 30 and 5 min predose, 30 min postdose (ie, 5 min before treadmill exercise challenge; baseline) and 5, 10, 15, 30, and 60 min after exercise challenge. The primary efficacy endpoint was maximum percentage fall from baseline in FEV(1) up to 60 min post-exercise challenge.
  
  
  RESULTS
  Mean maximum percentage fall in FEV(1) within 60 min post-exercise challenge was 6.2 ± 1.4% for albuterol MDPI versus 22.4 ± 1.4% for placebo MDPI (between-treatment difference: -16.2%; 95% CI: -20.2% to -12.1%; P < 0.0001). A significantly higher percentage of albuterol MDPI-treated patients were protected against EIB (<10% maximum FEV(1) fall post-exercise challenge) versus placebo MDPI (84.2% vs 15.8%; P < 0.0001). Protection with albuterol MDPI was evident within 5 min and maintained through 30 min; recovery was complete for both groups at 60 min. Treatment with a single dose of albuterol MDPI was generally well tolerated.
  
  
  CONCLUSIONS
  Albuterol MDPI provides clinically significant protection from EIB in adolescents and adults with EIB; no new safety issues were observed with short-term albuterol MDPI use. ClinicalTrials.gov identifier NCT01791972.
authors.affiliation: Allergy & Asthma Medical Group & Research Center, 5776 Ruffin Road, San Diego, CA 92123, USA. Electronic address: nkostrom@aol.com.
authors.forename: Nancy K
authors.initials: NK
authors.lastname: Ostrom
authors.affiliation: Teva Pharmaceuticals, 74 N.W. 176th Street, Miami, FL 33169, USA. Electronic address: herminia.taveras@tevapharm.com.
authors.forename: Herminia
authors.initials: H
authors.lastname: Taveras
authors.affiliation: Teva Pharmaceuticals, 74 N.W. 176th Street, Miami, FL 33169, USA. Electronic address: harald.iverson@tevapharm.com.
authors.forename: Harald
authors.initials: H
authors.lastname: Iverson
authors.affiliation: Colorado Allergy & Asthma Centers, 125 Rampart Way, Suite 150, Denver, CO 80230, USA. Electronic address: ds.pearlman@coloradoallergy.com.
authors.forename: David S
authors.initials: DS
authors.lastname: Pearlman
mesh_terms: D000293:Adolescent; D000328:Adult; D000420:Albuterol / Q000008:administration & dosage* / Q000494:pharmacology / Q000627:therapeutic use; D001250:Asthma, Exercise-Induced / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000494:pharmacology / Q000627:therapeutic use; D018592:Cross-Over Studies; D004311:Double-Blind Method; D058995:Dry Powder Inhalers; D005080:Exercise Test / Q000379:methods; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D013147:Spirometry / Q000379:methods; D055815:Young Adult
chemical_list: D001993:Bronchodilator Agents; D000420:Albuterol
keywords: Adrenergic beta-2 receptor agonists; Albuterol; Bronchoconstriction; Dry powder inhalers; Exercise-induced bronchospasm