Peak Inspiratory Flow and Dry Powder Inhaler Performance in COPD

Phase 4 Completed 30 enrolled Pulmonary Research Institute of Southeast Michigan GlaxoSmithKline · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of the study is to determine whether PIF is clinically important when using the Ellipta DPI device. In addition, the study will validate the best/most clinically appropriate way to perform a PIF maneuver, to determine the testing capabilities of the preferred PIF maneuver and to relate this PIF measurement to meaningful clinical outcomes in COPD patients

Timeline

Start: 2020-12-02
Primary completion: 2021-12-15
Completion: 2021-12-15

Outcome

Missed primary endpoint

registry analysis (superiority test); Suboptimal PIF vs Normal PIF; p = 0.33; Mean Difference (Final Values) 1; Chi-squared NCT04606394 ↗

Publications

Perugini V, Rhee CK, Moon JY, Pei Yee T, Ra SW, Pirina P, Yoo KH, Navarrete BA, Gouder C, Pacheco A, Navarro-Rolon A, Harlander M, Lapperre T, Loh SCH, Fole D, Naval E, Palacios PJR, Miravitlles M, Usmani O. Assessment of peak inspiratory flow in patients with chronic obstructive pulmonary disease: a multicentre, observational, prospective, real-life study. BMJ Open Respir Res. 2025 Sep 25;12(1):e002408. doi: 10.1136/bmjresp-2024-002408.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Salbutamol	Unknown	90 ug	Inhaled
Subject	Trelegy Ellipta	Unknown	25 ug	Inhaled
Subject	Trelegy Ellipta	Unknown	62.5 ug	Inhaled
Subject	Trelegy Ellipta	Unknown	100 ug	Inhaled