Abstract
Correct use and ease of use of a placebo dry powder inhaler was evaluated in two single-arm, United States-multicenter, phase-IV studies in adults with asthma ( n = 259) or chronic obstructive pulmonary disease (COPD; n = 278) who were receiving maintenance inhaler therapy. Subjects demonstrating correct placebo inhaler use within three attempts at screening were instructed to take once-daily inhalations from the inhaler for 28 ± 2 days (continuing usual maintenance), followed by randomization to complete one of two versions of an ease-of-use questionnaire and reassessment for correct inhaler use. At study end, 96% asthma/93% COPD subjects rated the placebo inhaler as "easy" or "very easy" to use while demonstrating correct use. Furthermore, 99% asthma/99% COPD subjects indicated it was "easy" or "very easy" to determine number of doses remaining, and 81%/84%, respectively, indicated they would be "likely" or "very likely" to request their current medication in the inhaler, if available. Adverse event (AE) rates were 12% asthma/15% COPD, most frequently headache (3%/3%). Treatment-related AEs were reported in one subject with asthma (cough) and four subjects with COPD (cough, n = 3; back pain, n = 1). At study end, most subject...Continue Reading
References
May 12, 1998·The Journal of Asthma : Official Journal of the Association for the Care of Asthma·J van der PalenA M Schildkamp
Feb 2, 2002·Scandinavian Journal of Primary Health Care·A E HesselinkJ T van Eijk
May 15, 2002·Journal of Aerosol Medicine : the Official Journal of the International Society for Aerosols in Medicine·Joan Serra-BatllesUNKNOWN Inhalation Devices Study Group
Jun 29, 2004·The European Respiratory Journal·B R CelliUNKNOWN ATS/ERS Task Force
Mar 29, 2007·Journal of Aerosol Medicine : the Official Journal of the International Society for Aerosols in Medicine·Job Van Der PalenNiek A Vermue
Oct 4, 2007·Respiration; International Review of Thoracic Diseases·Siegfried Wieshammer, Jens Dreyhaupt
Dec 18, 2007·Respiratory Medicine·Federico LavoriniGraham K Crompton
Mar 4, 2011·Respiratory Medicine·Andrea S MelaniUNKNOWN Gruppo Educazionale Associazione Italiana Pneumologi Ospedalieri
Dec 10, 2013·BMC Pulmonary Medicine·Henrik SvedsaterMark W Woepse
May 31, 2014·Respiratory Medicine·Piyush AroraPitambar Chakraborty
Jun 27, 2014·NPJ Primary Care Respiratory Medicine·Henrik SvedsaterEugene R Bleecker
Jun 14, 2015·Respiratory Care·Ariel Berlinski
Sep 16, 2015·Journal of Aerosol Medicine and Pulmonary Drug Delivery·Andrew C GrantKarl Garrill
Mar 2, 2016·Patient Preference and Adherence·Josep DarbàRainel Sánchez-de la Rosa
Apr 22, 2016·NPJ Primary Care Respiratory Medicine·Mark L LevySoren Pedersen
May 22, 2016·International Journal of Pharmaceutics·Sofia von SchantzAnne Juppo
Jun 4, 2016·Patient Preference and Adherence·Suzanne G Bollmeier, Theresa R Prosser
Sep 1, 2016·International Journal of Chronic Obstructive Pulmonary Disease·John H RileyStephanie S Harris
Feb 10, 2017·The European Respiratory Journal·Mathieu MolimardPierre-Olivier Girodet
Mar 24, 2017·NPJ Primary Care Respiratory Medicine·Job van der PalenNeil C Barnes
Apr 5, 2017·NPJ Primary Care Respiratory Medicine·Henry ChrystynMike Thomas