An Open-Label Study Evaluating the Performance of the Dose Indicator in a Metered Dose Inhaler Delivering Glycopyrrolate and Formoterol Fumarate in Patients with Moderate-to-Very Severe Chronic Obstructive Pulmonary Disease

Krishna Pudi, Gregory Feldman, Faisal Fakih, Peter Mack, Andrea Maes, Shahid Siddiqui, Earl St Rose, Colin Reisner, Krishna Pudi, Gregory Feldman, Faisal Fakih, Peter Mack, Andrea Maes, Shahid Siddiqui, Earl St Rose, Colin Reisner

Abstract

Background: GFF MDI is a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler formulated using co-suspension delivery technology. This open-label, single-arm multicenter study (NCT02268396) evaluated the accuracy, reliability, and functionality of the GFF MDI AeroCount® dose indicator when used by patients with chronic obstructive pulmonary disease (COPD).

Patients and methods: The study enrolled subjects (40-80 years of age) with an established clinical history (≥6 months) of COPD, who completed an electronic diary twice daily to record study-drug administration time, the number of actuations used, and pre- and post-dose dose indicator readings. The primary endpoint was the percentage of devices for which the number of subject-reported actuations was consistent (±20 actuations) with the dose indicator-based actuation count (equal to 130 minus the dose indicator reading) at the end of the treatment period (4 weeks). Safety was monitored throughout the study.

Results: A total of 138 subjects with moderate-to-very severe COPD (50.7% male; mean [standard deviation (SD)] age 62.1 [8.3] years) were enrolled and treated. Subject-reported actuation count and dose indicator-based actuation counts were consistent for 96.4% (132/137) of devices at the end of the treatment period (4 weeks) in the intent-to-treat (ITT) population and for all devices in the per-protocol (PP) population. The mean (SD) dose indicator-based actuation and subject-reported actuation counts in the ITT population (n = 137) were 113.4 (18.9) and 117.0 (19.0), respectively, with a mean (SD) difference of 3.6 (7.9). The mean (SD) dose indicator-based actuation and subject-reported actuation counts in the PP population (n = 112) were 116.8 (8.7) and 119.7 (8.1), respectively. There were no unexpected safety findings.

Conclusions: This study supported the accuracy, reliability, and utility of the dose indicator integrated into the GFF MDI device when used by patients with COPD.

Keywords: GFF MDI; chronic obstructive pulmonary disease; co-suspension delivery technology; dose indicator.

Conflict of interest statement

K.P. and G.F. have no potential conflicts of interest to disclose. F.F. is an employee of Florida Premier Research Institute, LLC, and has performed clinical trials for AstraZeneca and Pearl—a member of the AstraZeneca Group. E.S.R., P.M., and A.M. are employees of Pearl—a member of the AstraZeneca Group. C.R. is an employee of Pearl—a member of the AstraZeneca Group and an employee of AstraZeneca. S.S. is an employee of AstraZeneca and former employee of Pearl—a member of the AstraZeneca Group.

Figures

FIG. 1.
FIG. 1.
Study design. BID, twice daily; GFF, glycopyrrolate/formoterol fumarate; MDI, metered dose inhaler; PRN, as required; QID, four times daily. *Compliance reassessment visit.
FIG. 2.
FIG. 2.
Schematic of a GFF MDI device with the AeroCount® dose indicator. Reprinted by permission from AstraZeneca Pharmaceuticals LP.(4)
FIG. 3.
FIG. 3.
Subject-recorded actuation count versus dose indicator-based actuation count at the last available visit for (A) ITT population (n = 137) and (B) PP population (n = 112). GFF, glycopyrrolate/formoterol fumarate; ITT, intent-to-treat; MDI, metered dose inhaler; PP, per-protocol.

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Source: PubMed

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