AMPLIFY - D6571C00001 Duaklir USA Phase III Study

Summary

This is a multiple dose, randomized, parallel, double-blind, double-dummy, multicenter and multinational Phase III study to determine the efficacy and safety of Aclidinium bromide 400μg/Formoterol Fumarate (AB/FF) 12 μg compared to individual components and TIO (Tiotropium) 18 μg when administered to patients with stable chronic obstructive pulmonary disease (COPD).

Timeline

Start

2016-07-05

Primary completion

2017-06-08

Completion

2017-06-08

Outcome

Met primary endpoint

registry analysis (superiority test); AB/FF 400/12 μg vs AB 400 μg; p <0.0001; LS mean difference 0.084 (95% CI 0.051 to 0.117); Mixed model for repeated measures NCT02796677 ↗

registry analysis (superiority test); AB/FF 400/12 μg vs FF 12 μg; p = 0.0009; LS mean difference 0.055 (95% CI 0.023 to 0.088); Mixed model for repeated measures NCT02796677 ↗

paper AB/FF significantly improved trough FEV1 vs FF (55 mL, P<0.001) and AB was non-inferior to TIO. PMID 30962681 ↗

release “AstraZeneca today announced positive top-line results from the Phase III AMPLIFY trial for Duaklir* (aclidinium bromide/formoterol 400µg/12µg twice-daily), which met its primary endpoints” astrazeneca.com ↗

Publications

• Sethi S, Kerwin E, Watz H, Ferguson GT, Mroz RM, Segarra R, Molins E, Jarreta D, Garcia Gil E. AMPLIFY: a randomized, Phase III study evaluating the efficacy and safety of aclidinium/formoterol vs monocomponents and tiotropium in patients with moderate-to-very severe symptomatic COPD. Int J Chron Obstruct Pulmon Dis. 2019 Mar 22;14:667-682. doi: 10.2147/COPD.S189138. eCollection 2019.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aclidinium	Unknown	400 ug	Inhaled
Subject	Formoterol	Other / unclassified	12 ug	Inhaled
Subject	Tiotropium	Other / unclassified	18 ug	Inhaled

Indications