NCT03081247

To Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

A Randomized, Double-Blind, Parallel-Group, 12-Week, Chronic Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Pearl Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a 12-week chronic-dosing study to assess the efficacy and safety of BGF MDI compared to BFF MDI in subjects with moderate to very severe COPD.

Detailed description

This is a multicenter, randomized, double-blind, parallel-group, 12-week chronic-dosing study to assess the efficacy and safety of BGF MDI compared to BFF MDI in subjects with moderate to very severe COPD. The study has a total of 7 visits over a Screening Period of up to 28 days and a Treatment Period of 12 weeks followed by a telephone follow-up call 14 days after the last dose of study drug.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	BGF 320/14.4/9.6 µg MDI	Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI)
DRUG	BFF 320/9.6 µg	Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI)

Timeline

• Start date: 2018-04-16
• Primary completion: 2018-12-07
• Completion: 2018-12-07
• First posted: 2017-03-16
• Last updated: 2018-08-02

Regulatory

• FDA-regulated drug study