1. Inhaler Preference Comparing Two Alternative Dual Bronchodilator Regimens
Poster No: PA972
Riley JH1, Fahy WA2, Vahdati-Bolouri M2, Tabberer M2
1Respiratory Global Franchise, GSK, Medicines Research Centre, Stevenage, UK; 2 Respiratory Discovery Medicine, GSK, Stockley Park West, Middlesex, UK
Aims
Patient population
Of the 1,190 patients enrolled in the study, 967 were randomised and 961 were included in the ITT population (n=482 for UMEC/VI; n=479 for IND+TIO).
Demographics were similar between the two treatment groups: patients were predominantly male (74% in the UMEC/VI group; 71% in the IND+TIO group), White (94% in both groups) and had a mean age of 64 years (both groups).
Lung function at baseline was similar between the two groups: patients were mainly classified as Global Obstructive Lung Disease (GOLD) stage II or III (44%/46%, respectively, in the UMEC/VI group; 42%/46% in the IND+TIO group) with the remainder classified as GOLD stage IV. The majority of patients were in GOLD category D using mMRC (66% in the UMEC/VI group; 65% in the IND+TIO group).
Figure 1. Study design
Figure 2. Comparison of patient preferences for active or inactive inhalers by criterion (mITT)a
Bronchodilators, including long-acting muscarinic antagonists (LAMAs) and long-acting β2-agonists (LABAs), are an integral part of symptom management of stable chronic obstructive pulmonary disease (COPD).1
Simplifying inhaled drug delivery and dosing regimen may improve adherence to medication in chronic respiratory diseases.2
Many treatment combinations are available and inhaler types differ considerably.
This poster reports inhaler preference data from a triple-dummy study using two dual bronchodilator combinations.
TIO/IND – both once per day
Number of steps
Screen (-5 to -7 days prior to Visit 2)
Follow-up
Visit 1 2 3 4 5 6 7 8
7(±2) days
Pre-screen
Entry
Day 1
Day 2
Week 2
Week 4
Week 8
Week 12
Day 84 +1
Follow-up
UMEC/VI – once per day
Methods
Study design
Phase IIIb, multicentre, randomised, blinded, triple-dummy, parallel-group study (NCT ; GSK Study: ) performed over 12 weeks in 12 countries (Figure 1).3
Subjects completed a 5–7-day run-in period prior to randomisation.
The primary endpoint and study details are reported elsewhere.3
The triple-dummy design allowed the comparison of the ELLIPTA™ device with two other inhalers used in patients with COPD.
Overall inhaler preference
Overall, more patients indicated a preference for the ELLIPTA™ inhaler across evaluations for number of steps, time to use and overall preference compared with the Breezhaler® and HandiHaler® (Table 1).
12-week double-blind phase
Time to use
Comparison of preferences for active or placebo inhalers
When inhaler preference was compared for those receiving either active ELLIPTA™ (UMEC/VI) plus placebo HandiHaler® and Breezhaler®, or active HandiHaler® and Breezhaler® (TIO/IND) plus placebo ELLIPTA™, patients consistently preferred the ELLIPTA inhaler regardless of whether it contained active drug or placebo (Figure 2).
Over 63% of patients preferred the ELLIPTA™ inhaler in each case.
Results
Treatment
Patients received either once-daily umeclidinium/vilanterol (UMEC/VI) 62.5/25 mcg (delivering 55/22 mcg) via the ELLIPTA™ inhaler, placebo via the HandiHaler®, and placebo via the Breezhaler®, or once-daily indacaterol (IND) 150 mcg via the Breezhaler®, tiotropium (TIO) 18 mcg via the HandiHaler® and placebo via the ELLIPTA™ inhaler for 12 weeks.
Patients
Inclusion criteria were: age ≥40 years; a diagnosis of COPD; a smoking history ≥10 pack years; Modified Medical Research Council Dyspnoea Scale (mMRC) score ≥2; and pre- and post-salbutamol forced expiratory volume in 1 second (FEV1) ≤70% of predicted values.
Patient preference
In addition to the primary aim of this study, to demonstrate the non-inferiority of UMEC/VI compared with combined IND and TIO therapy in patients with moderate to very severe COPD, the study also compared subject preference across the ELLIPTA™, HandiHaler® and Breezhaler® inhalers.
Subjects completed the inhaler preference questionnaire5 at Day 84 or early withdrawal, if applicable.
Three questions regarding preference for the number of steps to use, time needed to use and ease of use were completed by the study subjects:
Which device do you prefer based on the number of steps needed to take your COPD medication?
Which device do you prefer based on the time needed to take your COPD medication?
Which device do you prefer based on how easy the device is to use?
Table 1. Summary of patient preference (mITT)
Criterion
Preferred inhaler
Subjects, n (%) N=961
Number of steps (n=942)
Breezhaler®
140 (15)
ELLIPTA™
595 (63)
HandiHaler®
64 (7)
No preference
143 (15)
Time to use (n=942)
118 (13)
620 (66)
62 (7)
142 (15)
Ease of use (n=942)
133 (14)
627 (67)
54 (6)
128 (14)
Conclusions
In this triple-dummy efficacy study, patients demonstrated a preference for the ELLIPTA™ inhaler compared with either the HandiHaler® or Breezhaler® with regards to number of steps, time needed for use and ease of use of each inhaler type.
Inhaler preference results were independent of whether patients received active or placebo medication for each inhaler type.
Ease of use
References
GOLD, Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease, [accessed June 2016].
Bryant J, et al. Respir Res 2013;14:109.
Kalberg C, et al. Drugs R D 2016;16:217–227.
Quanjer PH, et al. Eur Respir J. 2012;40:1324–1343.
Clark, M, et al. Value Health 2011;14:A255.
Acknowledgements
The presenting author (JHR), WAF, MV-B and MT are employees of GlaxoSmithKline (GSK) and hold GSK stocks/shares.
The authors wish to thank Amy Newlands for her participation in the study including protocol development, data analysis and interpretation, and her authorship of the corresponding abstract.
This study was funded by GSK (NCT ; GSK identifier: ).
Editorial support (in the form of writing assistance, assembling tables and figures, collating authors comments, grammatical editing, and referencing) was provided by Rachel Edwards, PhD, and Elizabeth Jameson, PhD, at Fishawack Indicia Ltd, UK, and was funded by GSK.
Breezhaler®
HandiHaler®
ELLIPTA™
No preference
mITT, patients from the modified intent-to-treat population that expressed a preference.
aInhalers were defined as active if they contained an active drug, and inactive if they contained placebo.
ELLIPTA® is a registered trademark of the GSK group of companies.
HandiHaler® is a registered trademark of Boehringer Ingelheim International GmbH.
Breezhaler® is a registered trademark of Novartis AG.
Presented at the European Respiratory Society (ERS) International Congress, London, UK, September 3–7, 2016