NCT03162055

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

A Randomised, Double-Blind, Double-Dummy, Multicentre, Parallel Group Study to Assess the 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 (AERISTO)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,119 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 40 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease COPD

Interventions

Type	Name	Description
DRUG	Glycopyrronium/Formoterol Fumarate	Metered dose inhaler (MDI), contains glycopyrronium/formoterol fumarate fixed-dose combination 7.2/4.8 μg per actuation
DRUG	umeclidinium/vilanterol	Dry powder inhaler (DPI), Each metered dose contains umeclidinium/vilanterol 62.5/ 25μg fixed-dose combination per inhalation

Timeline

• Start date: 2017-05-25
• Primary completion: 2018-05-04
• Completion: 2018-05-04
• First posted: 2017-05-22
• Last updated: 2019-05-22
• Results posted: 2019-05-22

Locations

107 sites across 7 countries: United States, Bulgaria, Canada, France, Hungary, Russia, Ukraine

Regulatory

• FDA-regulated drug study