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).

Trial Profile

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).

Completed
Phase of Trial: Phase III

Latest Information Update: 24 May 2017

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
  • Most Recent Events

    • 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.
    • 05 Nov 2013 Results from this trial supported a MAA in the EU.
    • 14 Aug 2013 The planned Q4 2013 submission of the NDA will be delayed, according to Forest Laboratories and Almirall S.A. The delay is related to resolving chemistry, manufacturing and control specifications associated with the combination formulation.
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