title: Prospective, open-label evaluation of a new albuterol multidose dry powder inhaler with integrated dose counter.
abstract: BACKGROUND
  Albuterol multidose dry powder inhaler (MDPI) with an integrated dose counter allows patients to track the number of remaining doses and to simplify dosing by eliminating the need to coordinate inhalation with actuation associated with metered-dose inhalers.
  
  
  OBJECTIVE
  To evaluate the functionality, reliability, and accuracy of the albuterol MDPI integrated dose counter in a real-world clinical setting.
  
  
  METHODS
  This open-label, phase III study enrolled patients ages ≥4 years with asthma or chronic obstructive pulmonary disease. Patients who demonstrated adequate MDPI inhaler technique and ≥90% compliance with dosing and diary completion during a run-in period qualified for treatment with albuterol MDPI with a dose counter (2 inhalations/dose; 90 μg/inhalation) twice daily for up to 50 days. Patient-reported counter readings and patient-reported actuations were recorded in daily diaries and were used to assess dose counter accuracy. An ease-of-use and satisfaction questionnaire was given at the final visit.
  
  
  RESULTS
  A total of 317 patients were enrolled in the study. The dose-cycle undercount (i.e., actuation occurred, but the counter display did not count down) was 2.05 per 200 actuations. The estimated mean ± standard error absolute value of the total discrepancy size after 200 actuations was 2.07 ± 0.140. Most patients (83%) were somewhat or very satisfied, and >90% were satisfied with ease of holding and/or handling, using and taking, and inhaling a dose from the device. The albuterol MDPI was generally well tolerated.
  
  
  CONCLUSIONS
  The albuterol MDPI dose counter functioned reliably and accurately. Albuterol MDPI was well tolerated, with a high degree of patient satisfaction in a real-world setting.
  
  
  BACKGROUND
  NCT01857323.
authors.affiliation: Allergy and Respiratory Center, Canton, Ohio, and 2Teva Pharmaceuticals, Miami, Florida, USA.
authors.forename: John
authors.initials: J
authors.lastname: Given
authors.forename: Herminia
authors.initials: H
authors.lastname: Taveras
authors.forename: Harald
authors.initials: H
authors.lastname: Iverson
mesh_terms: D000293:Adolescent; D000328:Adult; D000420:Albuterol / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy; D002648:Child; D002675:Child, Preschool; D004361:Drug Tolerance; D058995:Dry Powder Inhalers / Q000592:standards*; D006801:Humans; D036501:Metered Dose Inhalers / Q000592:standards*; D008875:Middle Aged; D009330:Nebulizers and Vaporizers / Q000592:standards; D017060:Patient Satisfaction / Q000706:statistics & numerical data*; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy; D011795:Surveys and Questionnaires
chemical_list: D000420:Albuterol