A Randomized, Double Blind, (Test Products), Chronic Dosing (7 Days), Four Period, Eight Treatment , Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Five Doses of PT003, One Dose of PT001 and One Dose of PT005 in Patients With Moderate to Severe COPD, Compared With Spiriva Handihaler (Tiotropium Bromide 18 microg, Open Label) as Active Control

Trial Profile

A Randomized, Double Blind, (Test Products), Chronic Dosing (7 Days), Four Period, Eight Treatment , Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Five Doses of PT003, One Dose of PT001 and One Dose of PT005 in Patients With Moderate to Severe COPD, Compared With Spiriva Handihaler (Tiotropium Bromide 18 microg, Open Label) as Active Control

Completed
Phase of Trial: Phase II

Latest Information Update: 01 Aug 2017

At a glance

  • Drugs Formoterol (Primary) ; Formoterol/glycopyrrolate (Primary) ; Glycopyrrolate (Primary) ; Tiotropium bromide
  • Indications Chronic obstructive pulmonary disease
  • Focus Therapeutic Use
  • Sponsors Pearl Therapeutics
  • Most Recent Events

    • 01 Aug 2017 Results published in the Respiratory Medicine
    • 01 Nov 2016 Results assessing safety and efficacypublished in the Respiratory Medicine.
    • 12 May 2014 According to the AstraZeneca media release, final results of this trial presented at the American Thoracic Society (ATS) 2014, on 19 May 2014.
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