A randomised open-label cross-over study of inhaler errors, preference and time to achieve correct inhaler use in patients with COPD or asthma: comparison of ELLIPTA with other inhaler devices.

Job Van Der Palen,Anoop J Chauhan,Paul Dlpm Van Der Valk,Chang-Qing Zhu,Martijn Goosens,Carol Stonham,Henry Chrystyn,Varsha Imber,Raj K Sharma,Henrik Svedsater,Mike Thomas,Tom Wilkinson,Neil C Barnes

doi:10.1038/npjpcrm.2016.79

Abstract

Errors in the use of different inhalers were investigated in patients naive to the devices under investigation in a multicentre, single-visit, randomised, open-label, cross-over study. Patients with chronic obstructive pulmonary disease (COPD) or asthma were assigned to ELLIPTA vs DISKUS (Accuhaler), metered-dose inhaler (MDI) or Turbuhaler. Patients with COPD were also assigned to ELLIPTA vs Handihaler or Breezhaler. Patients demonstrated inhaler use after reading the patient information leaflet (PIL). A trained investigator assessed critical errors (i.e., those likely to result in the inhalation of significantly reduced, minimal or no medication). If the patient made errors, the investigator demonstrated the correct use of the inhaler, and the patient demonstrated inhaler use again. Fewer COPD patients made critical errors with ELLIPTA after reading the PIL vs: DISKUS, 9/171 (5%) vs 75/171 (44%); MDI, 10/80 (13%) vs 48/80 (60%); Turbuhaler, 8/100 (8%) vs 44/100 (44%); Handihaler, 17/118 (14%) vs 57/118 (48%); Breezhaler, 13/98 (13%) vs 45/98 (46%; all P<0.001). Most patients (57–70%) made no errors using ELLIPTA and did not require investigator instruction. Instruction was required for DISKUS (65%), MDI (85%), Turbuhaler (71%), Handihaler (62%) and Breezhaler (56%). Fewer asthma patients made critical errors with ELLIPTA after reading the PIL vs: DISKUS (3/70 (4%) vs 9/70 (13%), P=0.221); MDI (2/32 (6%) vs 8/32 (25%), P=0.074) and significantly fewer vs Turbuhaler (3/60 (5%) vs 20/60 (33%), P<0.001). More asthma and COPD patients preferred ELLIPTA over the other devices (all P⩽0.002). Significantly, fewer COPD patients using ELLIPTA made critical errors after reading the PIL vs other inhalers. More asthma and COPD patients preferred ELLIPTA over comparator inhalers.

Highlights

Inhaled medication has an important role in the treatment of chronic obstructive pulmonary disease (COPD) and asthma, and the effectiveness of inhaled medications is strongly influenced by the adherence to these medications.[1,2,3,4,5]
A decrease in medication delivery associated with an incorrect inhaler technique can lead to poor efficacy,[6,7] with studies showing that 460% of patients use their inhaler ineffectively.[8,9,10,11]
32 of the planned 50 patients were entered into the ELLIPTA inhaler vs metered-dose inhaler (MDI) substudy due to a lack of patients who were naive to the MDI

Summary

Introduction

Critical errors made when using inhalers, which significantly reduce or completely inhibit drug delivery, have been identified for various inhalation devices. The development of an easy-to-use inhaler device that delivers the drug to the lungs effectively is important.[21] In addition, patient preference and satisfaction has been of increased interest over the past decade; preference for a particular medication or inhaler device may be associated with improved adherence with therapeutic regimens.[22] The choice of inhalation device is an important consideration because it can influence patients’ adherence to treatment, and potentially affects the long-term outcome.[22] device preference is interesting, errors in use are likely to have a greater effect on outcomes

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Results

Conclusion