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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).

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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).

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Apr 2019

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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

  • 17 Apr 2019 According to a Circassia media release, the product is approved worldwide, including in the European Union, under a number of brand names.
  • 01 Apr 2019 According to a Circassia media release, the company announces the US Food and Drug Administration (FDA) has approved Duaklir Pressair for the maintenance treatment of chronic obstructive pulmonary disease. The approval is based on a broad clinical database, including data from three phase III studies, ACLIFORM, AUGMENT, AMPLIFY and phase IV ASCENT study.
  • 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.

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