NCT02454959

Crossover Study to Assess the Efficacy of PT003 With and Without a Valved Holding Chamber in Subjects With Moderate to Severe COPD

A Randomized, Phase III, Two-period, Open-label, Chronic-dosing (7 Days), Multicenter, Crossover Study to Assess the Efficacy, Safety and Pharmacokinetics of PT003 in Subjects With Moderate to Very Severe COPD With and Without a Valved Holding Chamber

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

Summary

This is a Randomized, Phase III, Two-period, Open-label, Chronic-dosing (7 Days), Multi-center, Crossover Study to Assess the Efficacy of PT003 in Subjects with Moderate to Severe COPD with and without a Valved Holding Chamber.

Conditions

• COPD

Interventions

Type	Name	Description
DEVICE	GFF MDI (PT003) with Aerochamber	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) with Aerochamber Plus Valved Holding Chamber
DEVICE	GFF MDI (PT003) without Aerochamber	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) without Aerochamber Plus Valved Holding Chamber

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-03-25
• Completion: 2016-03-25
• First posted: 2015-05-27
• Last updated: 2017-04-19
• Results posted: 2017-04-19

Locations

6 sites across 1 country: United States