NCT02643082

A Study to Assess the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD

A Randomized, Double-Blind, Two Treatment, Two Period, Chronic Dosing (2 Weeks), Cross-Over, Single-Center Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Pearl Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance With Moderate to Severe COPD.

Detailed description

Enrolled patients with COPD who were randomized to receive either PT003 MDI or Placebo MDI first and then crossed over to receive the opposite intervention. The study consisted of 2 treatment periods of 14 days separated by a washout period of 5-21 days.

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	GFF MDI (PT003) 14.4/9.6μg	Glycopyrronium and Formoterol Fumarate
DRUG	Placebo MDI	Comparator: Placebo MDI which contains no active ingredients

Timeline

• Start date: 2015-12-23
• Primary completion: 2017-01-26
• Completion: 2017-01-26
• First posted: 2015-12-30
• Last updated: 2019-03-19
• Results posted: 2019-03-19

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study