drugset / Trial / NCT03022097

Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients

NCT03022097

Phase 3 Completed 1625 enrolled AstraZeneca Parexel · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a multiple dose, randomised, parallel, double blind, double dummy, multicentre and multinational Phase III study to determine the efficacy and safety of Aclidinium bromide/Formoterol fumarate compared with individual components and placebo and Aclidinium bromide compared with Placebo when administered to patients with stable Chronic Obstructive Pulmonary Disease (COPD).

Timeline

Start
2017-02-02
Primary completion
2022-04-14
Completion
2022-04-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Aclidinium Small molecule 400 ug Inhaled
Subject Formoterol Other / unclassified 12 ug Inhaled