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ORIGINAL PAPER
Fluticasone propionate/salmeterol hydrofluoroalkane via metered-dose inhaler with integrated dose counter: performance and patient satisfaction
K. SHETH 1 , R. L. WASSERMAN 2 , W. R. LINCOURT 3 , N. W. LOCANTORE 3 , J. CARRANZA-ROSENZWEIG 3 , C. CRIM 3
  1 Lafayette Allergy and Asthma Clinic, Lafayette, IN ,   2 Pediatric Allergy/Immunology Associates, PA, Dallas, TX ,   3 GlaxoSmithKline, Research Triangle Park, NC, USA
Correspondence to Ketan Sheth, MD, Lafayette Allergy and Asthma Clinic, 1345 Unity Place, Suite 145A, Lafayette, IN 47905, USA
Tel.: (765) 446-5040
Fax: (765) 446-5041
Email: ksheth@unityhc.com
 

Presented in part at the American Thoracic Society Annual Meeting, 20–25 May 2005, San Diego, CA, USA.
Study results registered at GlaxoSmithKline's Public Clinical Trial Register (SAS30033) at http://ctr.glaxowellcome.co.uk/Summary/fluticasonesalmeterol/studylist.asp.

Copyright 2006 The Authors Journal compilation 2006 Blackwell Publishing Ltd
KEYWORDS
Asthma • chronic obstructive pulmonary disease • dose counter • metered-dose inhaler • fluticasone propionate • salmeterol

Summary

AbstractIntroductionMethodsResultsDiscussionReferences

Currently, patients have to keep track of doses to determine when to replace their metered-dose inhalers (MDIs). This study evaluated the performance and patient satisfaction of a novel MDI with an integrated dose counter. In an open-label study at 38 outpatient centres, patients ≥12 years old with asthma or chronic obstructive pulmonary disease (COPD) received two actuations of fluticasone propionate/salmeterol 125/25 μg (115/21 μg ex-actuator) hydrofluoroalkane (ADVAIR® HFA) via MDI with counter twice a day until all 120 actuations were completed. Concordance between counter and diary recordings in patients who reported use of ≥90% of labelled actuations (completer population, n = 228) was high (discrepancy rate of 0.94%) and the incidence of device firing without changes in counter readings was low (0.13%). Mean expected actuations based on canister weights (114) were slightly lower than mean counter (121) and diary reported actuations (120). Upon study completion, 95% of patients were satisfied with the dose counter and 92% agreed it would help prevent them from running out of medication. Safety assessments (intent-to-treat population, n = 237) indicated that the drug was well tolerated. This integrated MDI counter may help patients maintain better disease control by enabling them to accurately track their medication supply.


Paper received May 2006; accepted July 2006

DIGITAL OBJECT IDENTIFIER (DOI)
10.1111/j.1742-1241.2006.01138.x About DOI

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