NCT02465567

Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)

A Randomized, Double-Blind, Multi-Center, Parallel-Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD (Ethos)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8,588 (actual)
• Sponsor: Pearl Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate to very severe COPD.

Detailed description

A randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations over a 52-week treatment period in subjects with moderate to very severe COPD.

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	BGF MDI 320/14.4/9.6 μg	Budensonide, Glycopyrronium, and Formoterol Fumarate
DRUG	GFF MDI 14.4/9.6 μg	Glycopyrronium, and Formoterol Fumarate
DRUG	BGF MDI 160/14.4/9.6 μg	Budensonide, Glycopyrronium, and Formoterol Fumarate
DRUG	BFF MDI 320/9.6 μg	Budensonide, and Formoterol Fumarate

Timeline

• Start date: 2015-06-30
• Primary completion: 2019-07-26
• Completion: 2019-07-26
• First posted: 2015-06-08
• Last updated: 2021-02-02
• Results posted: 2021-02-02

Locations

741 sites across 26 countries: United States, Argentina, Australia, Austria, Belgium, Canada, Chile, China, Czechia, France, Germany, Hungary, Italy, Japan, Mexico, Netherlands, New Zealand, Peru, Poland, Russia, Serbia, South Africa, Spain, Sweden, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study