A 24 Week Treatment, Multicenter, Randomized, Double Blinded, Double Dummy, Parallel-group, Clinical Trial Evaluating the Efficacy and Safety of Aclidinium Bromide 400 μg/Formoterol Fumarate 12 μg Fixed-dose Combination BID Compared With Each Monotherapy (Aclidinium Bromide 400 μg BID and Formoterol Fumarate 12 μg BID) and Tiotropium 18 μg QD When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.

Trial Profile

A 24 Week Treatment, Multicenter, Randomized, Double Blinded, Double Dummy, Parallel-group, Clinical Trial Evaluating the Efficacy and Safety of Aclidinium Bromide 400 μg/Formoterol Fumarate 12 μg Fixed-dose Combination BID Compared With Each Monotherapy (Aclidinium Bromide 400 μg BID and Formoterol Fumarate 12 μg BID) and Tiotropium 18 μg QD When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.

Completed
Phase of Trial: Phase III

Latest Information Update: 07 Sep 2017

At a glance

  • Drugs Aclidinium bromide/formoterol (Primary) ; Aclidinium bromide; Formoterol; Tiotropium bromide
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Acronyms AMPLIFY
  • Sponsors AstraZeneca
  • Most Recent Events

    • 07 Sep 2017 According to a Circassia media relaese, primary endpoint has been met. (Change from baseline in 1-hour morning post-dose dose FEV1 of AB/FF 400/12 g compared to AB 400 g at week 24.)
    • 07 Sep 2017 According to a Circassia media relaese, primary endpoint has been met. (Change from baseline in morning predose (trough) FEV1 of AB/FF 400/12 g compared to FF 12 g at week 24.)
    • 07 Sep 2017 According to a Circassia media relaese, primary endpoint has been met. (Change from baseline in morning predose (trough) FEV1 at week 24 comparing AB 400 g versus TIO 18 g to demonstrate non-inferiority.)
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