NCT02536508

Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

A Randomized, Double-Blind, Parallel-Group, 52-Week, Chronic-Dosing, Multi-Center Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 627 (actual)
• Sponsor: Pearl Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Detailed description

A Randomized, Double-Blind, Parallel-Group, 52-Week, Chronic-Dosing, Multi-Center Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Conditions

• COPD

Interventions

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

Timeline

• Start date: 2015-08-10
• Primary completion: 2017-09-12
• Completion: 2017-09-12
• First posted: 2015-09-01
• Last updated: 2021-02-26
• Results posted: 2021-02-26

Locations

64 sites across 1 country: United States

Regulatory

• FDA-regulated drug study