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. 2020 Jul 14:15:1713-1727.
doi: 10.2147/COPD.S248760. eCollection 2020.

Observational Real-World Study to Assess Clinical Characteristics and Device Satisfaction in Patients with COPD Treated with Glycopyrrolate/eFlow® CS

Judith J Stephenson  1 , Carole Dembek  2 , Amanda Caldwell-Tarr  3 , Rebecca M Conto  1 , Mark Paullin  1 , Edward M Kerwin  4
Affiliations

Observational Real-World Study to Assess Clinical Characteristics and Device Satisfaction in Patients with COPD Treated with Glycopyrrolate/eFlow® CS

Judith J Stephenson et al. Int J Chron Obstruct Pulmon Dis. .

Abstract

Purpose: To assess clinical characteristics and device satisfaction of patients with chronic obstructive pulmonary disease (COPD) treated with glycopyrrolate/eFlow® Closed System (CS) nebulizer (further referred to as eFlow) under real-world conditions.

Participants and methods: Patients with COPD currently using eFlow were identified by the study sponsor. Consenting patients who met study inclusion criteria completed a cross-sectional survey that included a device satisfaction questionnaire. Means, medians, and standard deviations were calculated.

Results: Sixty-six patients met inclusion criteria and completed the survey. Participants' mean ± standard deviation age was 64.9 ± 11.9 years and the majority were white (86.4%) and female (59.1%). Almost two-thirds were former smokers. Thirty-nine (59.1%) reported their COPD to be severe/very severe and 38 (57.6%) reported a COPD exacerbation resulting in a hospitalization, ER visit, or medication modification over the past 12 months. Among 55 participants who had previously used another type of nebulizer, 44 (80%) were overall "much more"/"somewhat more" satisfied with the eFlow compared with their previous nebulizer(s). Regardless of prior nebulizer use, 60 (90.9%) participants were "satisfied"/"very satisfied" overall with the eFlow. Assembly and disassembly, operation, and cleaning were perceived as being "easy"/"very easy" by at least 65% of participants. Among all participants, 57 (86.4%) were "confident"/"very confident" of glycopyrrolate administration. On a Likert scale of 1 ("I don't like it") to 7 ("I like it a lot"), mean scores were at least 5.9 for portability, ease of cleaning, size, weight, short administration time, and relative silence of the device. Over 80% of participants said they "probably"/"definitely" would continue to use eFlow.

Conclusion: Based on this real-world study, the majority of patients were highly satisfied with, and confident in, using eFlow.

Keywords: COPD; cross-sectional; device satisfaction; nebulizer; survey.

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Conflict of interest statement

Carole Dembek is an employee of Sunovion Pharmaceuticals Inc. Edward M Kerwin has received consultancy and advisory fees from Amphastar, AstraZeneca, Boehringer Ingelheim, Cipla, GlaxoSmithKline, Mylan, Novartis, Oriel, Pearl, Sunovion, Teva, and Theravance. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Survey sample disposition.
Figure 2
Figure 2
COPD symptomatology scores from the (A) CAT and (B) mMRC Dyspnea Scale. Abbreviations: CAT, COPD Assessment Test; mMRC, modified Medical Research Council.
Figure 3
Figure 3
eFlow CS characteristics ratings. Note: Scale: ‘1’ =“I don’t like it” and ‘7’ = “I like it a lot”. Abbreviation: SD, standard deviation.
Figure 4
Figure 4
Participants’ rating of the eFlow CS device (A) compared with previously used nebulizer(s) (B) regardless of previous nebulizer use.
Figure 5
Figure 5
eFlow CS device satisfaction questionnaire: comparison of positive responses from participants in the current real-world study versus the Phase 3 GOLDEN 5 clinical trial. Abbreviation: N/A, not applicable.
See this image and copyright information in PMC

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