NCT02937584

A Study to Assess the Effects of PT001 and PT005 MDI on Specific Image Based Parameters in Subjects With Moderate to Severe COPD

A Randomized, Double-Blind, Two Treatment, Two Period, Chronic Dosing (2 Weeks), Cross-Over, Multi-Center Study to Evaluate the Effects of PT001 and PT005 on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Pearl Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To assess the effect of treatment with Glycopyronnium (GP) MDI administered twice daily (BID) and Formoterol Fumarate (FF) MDI administered BID on specific image-based airway volumes and resistance in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) following chronic dosing after approximately two weeks treatment.

Conditions

• COPD, Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	GP MDI (PT001) 14.4 μg	Glycopyrronium
DRUG	FF MDI (PT005) 9.6 μg	Formoterol Fumarate

Timeline

• Start date: 2016-12-29
• Primary completion: 2018-05-28
• Completion: 2018-05-28
• First posted: 2016-10-18
• Last updated: 2019-07-24
• Results posted: 2019-07-24

Locations

2 sites across 1 country: Belgium

Regulatory

• FDA-regulated drug study