title: Prospective, open-label assessment of albuterol sulfate hydrofluoroalkane metered-dose inhaler with new integrated dose counter.
abstract: Metered-dose inhalers (MDIs) allow patients who require therapy for various respiratory diseases to deliver these therapies directly to the airways via inhalation. MDIs are designed to contain more propellant than required for administration of the labeled number of actuations; therefore, the amount of active medication/actuation remaining after administration of the labeled number of actuations may result in a lower than therapeutic dose of active medication. An MDI with an integrated dose counter provides the only reliable means by which a patient can track the amount of medication remaining in the MDI. This study evaluated the functionality, reliability, accuracy, and patient satisfaction with albuterol sulfate hydrofluoroalkane (HFA) MDI with a new integrated dose counter in the clinical setting. Patients aged ≥4 years with asthma, chronic obstructive pulmonary disease, or both, participated in this phase 4, prospective, open-label study. Treatment was twice-daily dosing with albuterol HFA MDI at 90 micrograms with dose counter for either 5 or 7 weeks. Concordance/agreement between daily patient recordings of actuations and counter readings was assessed with five discrepancy types: fire not count (undercount; primary end point), count not fire (overcount), fire count up within a dose (counter reading increased, instead of decreased, after MDI was actuated), count unknown fire (counter number at the beginning of a dosing session was less than counter number at the end of the previous session), and count up unknown fire (counter number at the beginning of a dosing session was greater than counter number at the end of the previous session). Responses to twelve questions designed to evaluate confidence, ease of use, and patient satisfaction were also analyzed. Overall discrepancy rate was 1.87 per 200 actuations. Primary end point (fire not count rate) was 0.30 per 200 actuations. Overall, ~95-97% of patients were "very satisfied" or "somewhat satisfied" with the albuterol HFA MDI with dose counter, its ease of use, and the ability to tell when it should be replaced. The albuterol HFA MDI with new integrated dose counter functioned reliably and accurately in the clinical setting. Overall patient satisfaction was high with the albuterol HFA MDI with new integrated dose counter and the device was shown to function reliably and accurately. Clinicaltrials.gov identifier: NCT01302587.
authors.affiliation: Allergy and Respiratory Center, Canton, OH, USA. JohnG@GivenMD.com
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
authors.forename: Mark
authors.initials: M
authors.lastname: Lepore
mesh_terms: D000293:Adolescent; D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000420:Albuterol / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D002648:Child; D054796:Drug Dosage Calculations; D005260:Female; D006801:Humans; D006845:Hydrocarbons, Fluorinated / Q000378:metabolism; D008297:Male; D036501:Metered Dose Inhalers; D008875:Middle Aged; D017060:Patient Satisfaction; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D055815:Young Adult; D005466:Fluorocarbons
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D000420:Albuterol; D001993:Bronchodilator Agents; D006845:Hydrocarbons, Fluorinated; C094049:apaflurane; D005466:Fluorocarbons