title: The functionality of a budesonide/formoterol pressurized metered-dose inhaler with an integrated actuation counter.
abstract: Integration of an actuation counter into pressurized metered-dose inhalers (pMDIs) can allow patients to accurately determine the remaining number of medication doses. This study was designed to assess the functionality of budesonide/formoterol (Symbicort; AstraZeneca, Dunkerque, France) pMDI with an integrated actuation counter in a clinical setting. Children aged > or =6 years, adolescents, and adults with inhaled corticosteroid-dependent asthma participated in this 6-week, randomized, open-label, multicenter study (SD-039-0743; D5896C00743). Patients were treated with budesonide/formoterol pMDI with no actuation counter (80/4.5 micrograms x 2 inhalations [160/9 micrograms] twice daily) during a 7- to 10-day run-in period. Qualifying patients were then randomized into one of three groups treated with budesonide/formoterol pMDI with actuation counter (80/4.5 micrograms x 2 inhalations [160/9 micrograms] twice daily): group 1, 96 actuations (24 days); group 2, 120 actuations (30 days); or group 3, 128 actuations (32 days). Actuation count was assessed using position of the counter arrow, patient/caregiver reports (daily log and actuation counter final reading), and device (canister plus actuation counter assembly) weight change. Patients/caregivers rated ease of device use. There was good agreement across treatment groups (n = 254) between patient/caregiver-reported actuation counts and counts determined by the angular position of the arrow. Analysis of device weight change versus other estimates of actuation counts in groups 1 and 2 indicated that the device did not undercount the number of actuations sprayed. Most patients (93%) indicated the device was "extremely easy" or "very easy" to use. Clinical functionality and reliability of the budesonide/formoterol pMDI device with an actuation counter were established.
authors.affiliation: PA Allergy and Asthma Consultants, 555 Second Avenue, Collegeville, PA 19426, USA.
authors.forename: Shailen
authors.initials: S
authors.lastname: Shah
authors.forename: Martha
authors.initials: M
authors.lastname: White
authors.forename: Tom
authors.initials: T
authors.lastname: Uryniak
authors.forename: Christopher D
authors.initials: CD
authors.lastname: O'Brien
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy*; D019819:Budesonide / Q000008:administration & dosage* / Q000627:therapeutic use; D000069502:Budesonide, Formoterol Fumarate Drug Combination; D002648:Child; D004338:Drug Combinations; D004983:Ethanolamines / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers / Q000009:adverse effects / Q000706:statistics & numerical data*; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents; D000069502:Budesonide, Formoterol Fumarate Drug Combination; D004338:Drug Combinations; D004983:Ethanolamines; D019819:Budesonide; D000068759:Formoterol Fumarate