A Randomized, Double Blind, Chronic Dosing, Placebo-Controlled, Parallel Group, Multi Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo and Spiriva Handihaler (Tiotropium Bromide 18 mcg Open-Label) as an Active Control

Trial Profile

A Randomized, Double Blind, Chronic Dosing, Placebo-Controlled, Parallel Group, Multi Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo and Spiriva Handihaler (Tiotropium Bromide 18 mcg Open-Label) as an Active Control

Completed
Phase of Trial: Phase III

Latest Information Update: 15 Jul 2017

At a glance

  • Drugs Formoterol (Primary) ; Formoterol/glycopyrrolate (Primary) ; Glycopyrrolate (Primary) ; Tiotropium bromide
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Acronyms PINNACLE 1
  • Sponsors Pearl Therapeutics
  • Most Recent Events

    • 15 Jul 2017 Results of post-hoc analysis assessing the impact of baseline symptom score on benefits of Glycopyrrolate/Formoterol using pooled data (n=3699) from PINNACLE-1 and PINNACLE-2 studies, published in the Chest Journal.
    • 24 May 2017 Results of a pooled post hoc analysis from PINNACLE-1 and PINNACLE-2 trials (n=3249) presented at the 113th International Conference of the American Thoracic Society
    • 24 May 2017 Results (n=3699) of post hoc analysis of pooled data from two phase III studies (NCT01854645 and NCT01854658) presented at the 113th International Conference of the American Thoracic Society
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