drugset / Trial / NCT02433834

Chronic Dosing Cross-Over Study to Assess the Efficacy and Safety of Glycopyrronium (PT001) in Adult Subjects With Intermittent Asthma or Mild to Moderate Persistent Asthma

NCT02433834

Phase 2 Completed 248 enrolled Pearl Therapeutics, Inc.
RandomizedCrossoverQuadruple-blindTreatment

Summary

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

Timeline

Start
2015-05-27
Primary completion
2016-03-26
Completion
2016-03-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Glycopyrronium Unknown 1.9 ug Inhaled
Subject Glycopyrronium Unknown 3.6 ug Inhaled
Subject Glycopyrronium Unknown 7.2 ug Inhaled
Subject Glycopyrronium Unknown 14.4 ug Inhaled
Subject Glycopyrronium Unknown 28.8 ug Inhaled
Comparator salmeterol xinafoate Unknown 50 ug Inhaled

Indications