Efficacy and Safety of Glycopyrronium/Formoterol Fumarate Fixed-dose Combination Relative to Umeclidinium/Vilanterol Fixed-dose Combination Over 24 Weeks in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Summary

This is a phase IIIb randomised, double-blind, double-dummy, multicentre, parallel group, 24 week study to assess the efficacy and safety of Glycopyrronium/Formoterol Fumarate (GFF) fixed-dose combination 7.2/4.8 μg 2 inhalations twice daily compared to Umeclidinium/Vilanterol (UV) 62.5/25 μg fixed-dose combination 1 inhalation once daily in Patients with moderate to very severe COPD.

Timeline

Start

2017-05-25

Primary completion

2018-05-04

Completion

2018-05-04

Outcome

Mixed primary results

paper For the primary endpoints, GFF MDI was non-inferior to UV DPI (using a margin of - 50 mL) for peak FEV1 PMID 31267366 ↗

paper but not for trough FEV1 (LSM difference - 87.2 mL; - 117.0, - 57.4). PMID 31267366 ↗

registry analysis (superiority test); Glycopyrronium/Formoterol Fumarate vs Umeclidinium/Vilanterol; p = 0.5516; Least Square Mean Difference -1.7 (97.5% CI -30.3 to 27.0); Repeated measures analysis NCT03162055 ↗

Publications

• Maltais F, Ferguson GT, Feldman GJ, Deslee G, Bourdin A, Fjallbrant H, Siwek-Posluszna A, Jenkins MA, Martin UJ. A Randomized, Double-Blind, Double-Dummy Study of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Relative to Umeclidinium/Vilanterol Dry Powder Inhaler in COPD. Adv Ther. 2019 Sep;36(9):2434-2449. doi: 10.1007/s12325-019-01015-3. Epub 2019 Jul 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Formoterol	Other / unclassified	4.8 ug	Inhaled
Subject	Glycopyrronium	Unknown	7.2 ug	Inhaled
Comparator	Umeclidinium	Other / unclassified	62.5 ug	Inhaled
Comparator	Vilanterol	Other / unclassified	25 ug	Inhaled

Indications