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A Randomized, Double-Blind, Chronic-Dosing (14 Days), 5-Period, 7-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multicenter, Dose-ranging Study to Assess the Efficacy and Safety of PT001 Relative to Placebo Metered Dose Inhaler and Open-Label Serevent Diskus in Adult Subjects With Intermittent Asthma or Mild to Moderate Persistent Asthma

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Trial Profile

A Randomized, Double-Blind, Chronic-Dosing (14 Days), 5-Period, 7-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multicenter, Dose-ranging Study to Assess the Efficacy and Safety of PT001 Relative to Placebo Metered Dose Inhaler and Open-Label Serevent Diskus in Adult Subjects With Intermittent Asthma or Mild to Moderate Persistent Asthma

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 14 Jan 2020

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At a glance

  • Drugs Glycopyrrolate (Primary) ; Salmeterol
  • Indications Asthma
  • Focus Therapeutic Use
  • Sponsors Pearl Therapeutics

Most Recent Events

  • 01 Jun 2018 Results published in the Respiratory Medicine
  • 31 May 2017 Status changed from active, no longer recruiting to completed.
  • 24 May 2017 Primary endpoint (Peak Change From Baseline in FEV1 Within 3 Hours Post-dosing on Day 15 for all Glycopyrrolate (GP) MDI doses versus Placebo) has been met, according to results presented at the 113th International Conference of the American Thoracic Society.

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