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: 08 Mar 2017

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

    • 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.
    • 29 Jul 2013 As the timing for results presentation didn't coincide with the European Respiratory Congress (ERC) submission deadline, results will be presented at a later scientific congress, according to an Almirall media release.
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