A Phase III, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo for 24- Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD).
Phase of Trial: Phase III
Latest Information Update: 01 Jun 2018
At a glance
- Drugs Aclidinium bromide/formoterol (Primary) ; Aclidinium bromide; Formoterol
- Indications Chronic obstructive pulmonary disease
- Focus Registrational; Therapeutic Use
- Acronyms AUGMENT; AUGMENT/COPD
- Sponsors Forest Laboratories
- 01 Jun 2018 According to a Circassia media release, company announced the submission of a New Drug Application to the United States Food and Drug Administration for Duaklir Pressair for the treatment of chronic obstructive pulmonary disease. The NDA is supported by the data from the AMPLIFY study, results from two previous Duaklir phase III studies, ACLIFORM and AUGMENT, and exacerbation data from the ASCENT trial.
- 22 May 2018 According to a Circassia media relaese, Submission of a New Drug Application (NDA) seeking marketing approval for Duaklir in the United States is anticipated in the coming weeks. The NDA will include data from the AMPLIFY study, results from two previous Duaklir phase III studies, ACLIFORM and AUGMENT, and exacerbation data from the ASCENT trial.
- 24 May 2017 Results for the dvelopment and validation of the early morning symptoms of COPD instrument (EMSCI), presented at the 113th International Conference of the American Thoracic Society.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History