Ellipta Reports Significantly Better Inhaler Use to Device Combinations

The single-use triple-therapy device has proven significantly more easily managed by patients in a crossover study.

Job van der Palen

A new study has found that patients with chronic obstructive pulmonary disease (COPD) better manage proper inhaler use with 1 branded single-use device than others.

Triple-therapy single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI; Ellipta) showed superior rates of correct patient use and reduced health care provider instruction in a multicenter, single-visit, randomized, open-label, crossover study that compared the GlaxoSmithKline (GSK)-manufactured device to 3 of its market competitors.

The study, funded by GSK, was presented at the 2018 American Thoracic Society (ATS) International Conference in San Diego, CA. The compared therapies included fluticasone/salmeterol (Diskus), tiotropium (HandiHaler), and budersonide/formoterol (Turbuhaler).

Patients with COPD were assigned to 1 of 2 substudies, and randomized to an inhaler sequence and preference questionnaires. The substudies included Ellipta versus Diskus plus Handihaler, and Ellipta versus Turbuhaler plus Handihaler.

Enrolled patients were at least 40 years old, with a smoking history of at least 10 pack-years. Patients were naïve to Ellipta and Handihaler, naïve to Diskus if in substudy 1, and naïve to Turbuhaler if in substudy 2.

Health care providers responded to patient errors in the observed single-use administration by providing up to 2 helpful instructions, with reassessment given after each instruction. A checklist defining critical and overall errors for each inhaler — as developed by previous literature review — was used to assess device use correctness.

Researchers, led by Job van der Palen, of the Medisch Spectrum Twente hospital in Enschede, the Netherlands, anticipated that Ellipta — a device that administers inhaled corticosteroid (ICS), long-acting beta2 agonist (LABA), and long-acting meta agonist (LAMA) in a single use — would report significantly less patient errors than dual inhalers administering the same therapies.

They were proven right by overwhelming study results. Of the 80 patients administered Diskus plus Handihaler in the first substudy, 60 (75%) reported at least 1 critical error (P < 0.001). In the second substudy, 58 of the 79 (73%) patients administered Turbuhaler plus HandiHaler reported at least 1 critical error (P < 0.001). In the ELLIPTA groups from both studies, a combined 18 of 159 (9%) patients reported critical errors — 9 in each group.

Patients with COPD provided ELLIPTA also required significantly fewer instructions from their attending health care provider at administration. In substudy 1, 76% of patients reported correct inhaler use without provider instruction, while just 20% of dual therapy patients did so. In substudy 2, the disparity widened to 78% of patients correctly using ELLIPTA, and another 20% of dual therapy patients correctly using their devices.

In an interview with MD Magazine, van der Palen joked the analysis and its eventual findings did not require rocket science to foresee.

“If you combine more inhalers, you create more opportunities for errors,” van der Palen said. “It confirms that if you have the option of prescribing one inhaler instead of two, yes you should do that.”

Though the study did not speak for patient treatment adherence, van der Palen noted that previous literature indicates that patients with COPD or asthma who preferred an inhaler device to others often have better adherence.

Ellipta — the first and only device of its kind marketed in the US for the delivery of ICS/LABA/LAMA in a single use — is still not the end game for respiratory therapy, van der Palen said. The researcher expressed hope for the further development of smart technology that will allow health care providers to track both patient inhaler adherence and proper use.

“That’s probably going to be a huge step forward, because we’re already sure not a lot of patients adhere to their medication,” van der Palen said.

Van der Palen referred to an ongoing study in his home country country that is testing such a device in children with asthma. Ideally, the device would be capable of measuring and reporting metrics pertaining to tilt, use rate, and variations of flow. Eventually, both adherence and overall asthma care could improve.

“A lot of companies here actually measure activation and not flow, and so as long as you don’t have the flow, it’s no good,” van der Palen said.

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