title: A Preference Study of Two Placebo Dry Powder Inhalers in Adults with COPD: ELLIPTA® Dry Powder Inhaler (DPI) versus DISKUS® DPI.
abstract: Patients' preference is an important factor in selecting an inhaler treatment for COPD. The DISKUS® dry powder inhaler (DPI), which has been available to deliver several COPD medications for a decade, and the ELLIPTA® DPI, developed for the delivery of newer once-daily medications for patients with COPD, were studied in terms of patient preference and inhaler-specific attributes. We conducted a randomized, open-label, crossover study in patients with COPD. Patients used placebo ELLIPTA DPI once daily and placebo DISKUS DPI twice daily, for ∼1 week each, while continuing their COPD medications. Endpoints were: inhaler preference based on size of the numbers on the dose-counter (primary); the number of steps needed and inhaler size (secondary); and based on comfort of the mouthpiece, ease of opening, overall preference, and dosing regimen preference ('other'). Safety assessments included adverse events (AEs). A total of 287 patients were randomized. A significantly (p < 0.001) larger proportion of patients preferred the ELLIPTA DPI over DISKUS DPI for each of the tested attributes and overall, and preferred once-daily over twice-daily dosing. AEs were reported for 36 patients (13%); one (dry mouth) was considered to be related to the placebo-containing DISKUS DPI. Three patients had five non-fatal serious AEs, none were deemed inhaler-related. This study demonstrated that more patients with COPD preferred five specific inhaler attributes of the ELLIPTA DPI over DISKUS DPI and overall, and preferred once-daily versus twice-daily dosing. Safety profiles were consistent with those expected for COPD.
authors.affiliation: a 1 GSK, Research Triangle Park , North Carolina , USA.
authors.forename: Suyong
authors.initials: S
authors.lastname: Yun Kirby
authors.affiliation: b 2 GSK, Uxbridge , Middlesex , United Kingdom.
authors.forename: Chang-Qing
authors.initials: CQ
authors.lastname: Zhu
authors.affiliation: c 3 Clinical Research Institute of Southern Oregon , Medford , Oregon , USA.
authors.forename: Edward M
authors.initials: EM
authors.lastname: Kerwin
authors.affiliation: a 1 GSK, Research Triangle Park , North Carolina , USA.
authors.forename: Richard H
authors.initials: RH
authors.lastname: Stanford
authors.affiliation: a 1 GSK, Research Triangle Park , North Carolina , USA.
authors.forename: George
authors.initials: G
authors.lastname: Georges
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D058995:Dry Powder Inhalers; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D001993:Bronchodilator Agents
keywords: dosing frequency; drug delivery; inhaler attributes; patient adherence; patient preference; treatment outcomes