Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-dose Combinations Compared With Individual Components and Placebo When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.

Trial Profile

Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-dose Combinations Compared With Individual Components and Placebo When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.

Completed
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 ACLIFORM; ACLIFORM/COPD
  • Sponsors Almirall S.A.
  • Most Recent Events

    • 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.
    • 05 Nov 2013 Results from this trial supported a MAA in the EU.
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