title: Correct usage, ease of use, and preference of two dry powder inhalers in patients with COPD: analysis of five phase III, randomized trials.
abstract: BACKGROUND
  Handheld inhalers are used to deliver treatment for COPD. Incorrect usage leads to suboptimal disease control. Complex treatment regimens and use of multiple inhalers may reduce patient compliance. The Anoro Ellipta™ dry powder inhaler (DPI) simultaneously delivers umeclidinium bromide (UMEC) and vilanterol (VI) without coformulation being required.
  
  
  OBJECTIVE
  To assess the correct usage and ease of use of the Ellipta™ DPI administering UMEC/VI and to compare patient preference for Ellipta™ with the HandiHaler(®) through exploratory analyses of patient and observer questionnaires in five Phase III studies.
  
  
  METHODS
  Two Phase III, 3-month double-blind, placebo-controlled studies assessed the correct usage of the Ellipta™ DPI at Day 1 and after 6 weeks, and ease of use of the Ellipta™ DPI using a nonvalidated patient questionnaire after 6 weeks or early withdrawal. In three 6-month, blinded double-dummy, active comparator studies (two Phase IIIa and one Phase IIIb), patients completed a COPD device preference questionnaire between the Ellipta™ DPI and the Handi-Haler(®) at Day 168 (Week 24) or early withdrawal.
  
  
  RESULTS
  In the 3-month placebo-controlled studies, ≥98% of patients used the Ellipta™ DPI correctly and 99% of patients found the inhaler easy/very easy-to-use and the dose counter easy/very easy to read. Across the two Phase IIIa active comparator studies, patients consistently stated a preference for the Ellipta™ DPI over HandiHaler(®) regarding the number of steps to use (59% vs 17%), time taken to use (62% vs 14%), and ease of use (63% vs 15%) regardless of which inhaler contained active drug. Results were consistent in the Phase IIIb active comparator study.
  
  
  CONCLUSIONS
  Delivery of UMEC/VI via the Ellipta™ DPI was considered easy-to-use, and patients with COPD demonstrated clear preference for this inhaler compared with HandiHaler(®).
authors: MDC Global Clinical Development - UK, GlaxoSmithKline.
authors: John H
authors: JH
authors: Riley
authors: Value Evidence and Outcomes, GlaxoSmithKline, Uxbridge, Middlesex, UK.
authors: Maggie
authors: M
authors: Tabberer
authors: Respiratory Medicines Development Center, GlaxoSmithKline, Durham, NC, USA.
authors: Nathalie
authors: N
authors: Richard
authors: Respiratory Medicines Development Center, GlaxoSmithKline, Durham, NC, USA.
authors: Alison
authors: A
authors: Donald
authors: Respiratory Medicines Development Center, GlaxoSmithKline, Durham, NC, USA.
authors: Alison
authors: A
authors: Church
authors: Respiratory Medicines Development Center, GlaxoSmithKline, Durham, NC, USA.
authors: Stephanie S
authors: SS
authors: Harris
mesh_terms: D000280:Administration, Inhalation; D001592:Benzyl Alcohols / Q000008:administration & dosage* / Q000009:adverse effects; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002722:Chlorobenzenes / Q000008:administration & dosage* / Q000009:adverse effects; D017326:Clinical Trials, Phase III as Topic; D004311:Double-Blind Method; D004338:Drug Combinations; D058995:Dry Powder Inhalers; D004867:Equipment Design; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D018727:Muscarinic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D010349:Patient Compliance; D010353:Patient Education as Topic; D057240:Patient Preference; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D011812:Quinuclidines / Q000008:administration & dosage* / Q000009:adverse effects; D016032:Randomized Controlled Trials as Topic; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D001592:Benzyl Alcohols; D001993:Bronchodilator Agents; D002722:Chlorobenzenes; D004338:Drug Combinations; C573971:GSK573719; D018727:Muscarinic Antagonists; D011812:Quinuclidines; C550468:vilanterol
keywords: Ellipta™; chronic obstructive pulmonary disease (COPD); ease of use; inhaler; preference; umeclidinium/vilanterol