drugset / Trial / NCT01350128

PT001 MDI Versus Atrovent Study in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT01350128 ↗

Phase 2 Completed 103 enrolled Pearl Therapeutics, Inc.
RandomizedCrossoverQuadruple-blindTreatment

Summary

The overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.

Timeline

Start
2011-05-01
Primary completion
2011-10-01
Completion
2011-10-01

Outcome

Met primary endpoint

paper All GP MDI treatments were superior to placebo MDI for the primary efficacy endpoint (all p < 0.0001). PMID 29506504 ↗

Drugs

EvaluationDrugModalityDoseRoute
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 Ipratropium Small molecule 34 ug Inhaled