NCT02766608

Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD

A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005, PT008, and Open-label Symbicort® Turbuhaler®, as an Active Control, on Lung Function Over a 24-Week Treatment Period in Subjects With Moderate to Very Severe COPD

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,389 (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, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID.

Detailed description

This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be to one of the following five treatment groups:BFF MDI 320/9.6 μg BID (N=660), BFF MDI 160/9.6 μg BID, FF MDI 9.6 μg BID, BD MDI 320 μg BID, Symbicort®, TBH 400/12 μg BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 24 weeks.

Conditions

• Chronic Obstructive Pulmonary Disorder

Interventions

Type	Name	Description
DRUG	BFF MDI 320/9.6 μg	Blinded Treatment
DRUG	BFF MDI 160/9.6 μg	Blinded Treatment
DRUG	FF MDI 9.6 μg	Blinded Treatment
DRUG	BD MDI 320 μg	Blinded Treatment
DRUG	Symbicort® TBH 400/12 μg BID	Open Label

Timeline

• Start date: 2016-05-31
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-05-10
• Last updated: 2019-09-24
• Results posted: 2019-09-24

Locations

259 sites across 8 countries: United States, Canada, Czechia, Germany, Hungary, Poland, Russia, South Korea