NCT02685293

Study to Evaluate the Treatment Effect of PT003 on Cardiovascular Hemodynamics in Subjects With Moderate to Severe COPD

A Randomized, Phase IIIb, Two-period , Double-blind, Two-treatment, Chronic-dosing (7 Days), Single-center Crossover Study to Evaluate the Treatment Effect of PT003 on Cardiovascular Hemodynamics in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease, Compared With Placebo

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Pearl Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, single-center, chronic-dosing (7 days), two-period, two-treatment, cross-over study to evaluate the treatment effect of PT003 compared with that of Placebo MDI on Cardiovascular Hemodynamics following chronic-dosing (7 days) in subjects with moderate to severe COPD.

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	GFF MDI (PT003)	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)
DRUG	Placebo MDI	Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol

Timeline

• Start date: 2016-12-09
• Primary completion: 2018-06-06
• Completion: 2018-06-06
• First posted: 2016-02-18
• Last updated: 2019-08-28
• Results posted: 2019-08-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study