NCT02727660

A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)

A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,876 (actual)
• Sponsor: Pearl Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.

Detailed description

This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be randomized to one of the following three treatment groups: PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 52 weeks.

Conditions

• Chronic Obstructive Pulmonary Disorder

Interventions

Type	Name	Description
DRUG	BFF MDI (PT009) 320/9.6 μg	Blinded Treatment
DRUG	BFF MDI (PT009) 160/9.6 μg	Blinded Treatment
DRUG	FF MDI (PT005) 9.6 μg	Blinded Treatment

Timeline

• Start date: 2016-04-29
• Primary completion: 2018-04-04
• Completion: 2018-04-04
• First posted: 2016-04-04
• Last updated: 2019-09-26
• Results posted: 2019-09-26

Locations

282 sites across 19 countries: United States, Argentina, Austria, Belgium, Brazil, Canada, Chile, Denmark, Germany, Italy, Mexico, Norway, Peru, Puerto Rico, Russia, South Africa, Spain, Sweden, United Kingdom