A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (7 Days), Four-Period, Eight-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Two Doses of PT003, Two Doses of PT005 and One Dose of PT001 in Patients With Moderate to Very Severe COPD, Compared With Foradil Aerolizer (12 microg, Open-Label) and Spiriva Handihaler (18 microg, Open-Label) as Active Controls.

Trial Profile

A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (7 Days), Four-Period, Eight-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Two Doses of PT003, Two Doses of PT005 and One Dose of PT001 in Patients With Moderate to Very Severe COPD, Compared With Foradil Aerolizer (12 microg, Open-Label) and Spiriva Handihaler (18 microg, Open-Label) as Active Controls.

Completed
Phase of Trial: Phase II

Latest Information Update: 29 Apr 2017

At a glance

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

    • 11 Sep 2013 Pooled tolerability results presented at the 23rd Annual Congress of the European Respiratory Society.
    • 21 May 2012 Results reported at the 108th International Conference of the American Thoracic Society.
    • 21 May 2012 Results reported at the 108th International Conference of the American Thoracic Society.
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