A Randomized, Double Blind (Test Products and Placebo), Chronic Dosing (14 Days), Four Period, Eight Treatment, Placebo-Controlled, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Six Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Spiriva Handihaler (Tiotropium Bromide, Open Label) as An Active Control.

Trial Profile

A Randomized, Double Blind (Test Products and Placebo), Chronic Dosing (14 Days), Four Period, Eight Treatment, Placebo-Controlled, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Six Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Spiriva Handihaler (Tiotropium Bromide, Open Label) as An Active Control.

Completed
Phase of Trial: Phase II

Latest Information Update: 05 Dec 2013

At a glance

  • Drugs Glycopyrrolate (Primary) ; Tiotropium bromide
  • Indications Chronic obstructive pulmonary disease
  • Focus Adverse reactions; 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.
    • 13 Sep 2012 Optimal doses for phase III trials have been identified and results will be presented at medical meetings in 2013, according to a Pearl Therapeutics media release.
    • 01 Aug 2012 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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