CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,119 enrolled
Drug / intervention
Glycopyrronium/Formoterol Fumarate +1 moredrug
Likely dose
Glycopyrronium/Formoterol Fumarate 4.8 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03162055
NCT03162055Phase 3Completed
CompareCT.gov

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)

AstraZeneca·interventional·Posted May 22, 2017·Updated May 22, 2019

In Brief

A Phase 3 clinical trial evaluating Glycopyrronium/Formoterol Fumarate and umeclidinium/vilanterol for Chronic Obstructive Pulmonary Disease COPD. Completed, enrolled 1,119 participants across 107 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease COPD
CountriesBulgaria, Canada, France, Hungary, Russia, Ukraine, United States
CollaboratorsParexel International Ltd, Cognizant Technology Solution, CISCRP, eResearchTechnology, QuintilesIMS Limited, Corporate Translations Inc

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMay 22, 2017
Enrollment StartMay 25, 2017
Primary CompletionMay 4, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.1 years ago

Interventions

Glycopyrronium/Formoterol Fumaratedrug

Metered dose inhaler (MDI), contains glycopyrronium/formoterol fumarate fixed-dose combination 7.2/4.8 μg per actuation

umeclidinium/vilanteroldrug

Dry powder inhaler (DPI), Each metered dose contains umeclidinium/vilanterol 62.5/ 25μg fixed-dose combination per inhalation