A randomized, open-label, single-visit, crossover study simulating triple-drug delivery with Ellipta compared with dual inhaler combinations in patients with COPD

Abstract

Background

Administering maintenance COPD therapy with a combination of multiple inhalers may increase inhaler errors. This study evaluated the potential benefits of using a single Ellipta dry powder inhaler (DPI) compared with two combinations of DPIs commonly used to deliver triple maintenance therapy.

Methods

Patients receiving inhaled COPD medication were enrolled in this multicenter, randomized, open-label, placebo-device, crossover study with a 2×2 complete block design (NCT298218), which comprised two substudies: Ellipta vs Diskus + HandiHaler (substudy 1) or Turbuhaler + HandiHaler (substudy 2). Patients demonstrated inhaler use after reading the relevant patient information leaflet (PIL). A trained investigator assessed user errors (critical errors [errors likely to result in no or significantly reduced medication being inhaled] and overall errors). The primary endpoint was the proportion of patients making ≥1 critical error after reading the PIL. The secondary endpoints included error rates during ≤2 reassessments following investigator instruction (if required), instruction time, and patient preference.

Results

After reading the PIL, significantly fewer patients made critical errors with Ellipta compared with Diskus + HandiHaler (9% [7/80] vs 75% [60/80], respectively; P<0.001) or Turbuhaler + HandiHaler (9% [7/79] vs 73% [58/79], respectively; P<0.001). The number of patients making overall errors was also lower with Ellipta vs tested inhaler combinations (P<0.001 for each substudy). The median instruction time needed for error-free use was shorter with Ellipta in substudies 1 and 2 (2.7 and 2.6 minutes, respectively) vs either combination (10.6 [Diskus + HandiHaler] and 11.3 minutes [Turbuhaler + HandiHaler], respectively). Significantly more patients preferred Ellipta over Diskus + HandiHaler or Turbuhaler + HandiHaler overall for taking their COPD medication (81% vs 9% and 84% vs 4%, respectively) and per the number of steps for taking their COPD medication (89% vs 8% and 91% vs 5%, respectively).

Conclusion

Fewer patients with COPD made critical errors with the single DPI, and patients required less instruction time, compared with each dual DPI combination.

Keywords:

• COPD
• triple therapy
• instruction
• patient preference
• inhaler technique
• critical errors

Acknowledgments

The authors would like to thank Valerie Millar (GSK, Uxbridge, UK), Rehan Ali (Lorien, UK), and Collins Mutua (Phastar, Kenya) for their support in data analysis for this paper. Editorial support (in the form of writing assistance, collating author comments, assembling tables and/or figures, grammatical editing, fact checking, and referencing) was provided by Catherine Elliott, BSc, of Gardiner-Caldwell Communications (Macclesfield, UK) and was funded by GSK. Ellipta and Diskus are trademarks owned by or licensed to the GSK group of companies. Turbuhaler is a trademark of AstraZeneca. HandiHaler is a trademark of Boehringer Ingelheim. This study was funded by GSK (ClinicalTrials.gov number NCT2982187; GSK study 206215).

Author contributions

Literature search: DM, JvdP. Study design: DM, JvdP, AP. Data collection: WMvB. All authors contributed toward data analysis and interpretation, drafting and critically revising the paper, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.

Disclosure

AP, RS, DM, and NB are employees of GSK and hold stocks and/or shares. The authors report no other conflicts of interest in this work.