NCT01854658

Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2)

A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (24 Weeks), Placebo-Controlled, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,615 (actual)
• Sponsor: Pearl Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks), placebo-controlled study to assess the efficacy and safety of Glycopyrrolate (GP and Formoterol Fumarate (FF) combination metered-dose inhaler (MDI) (GFF; PT003), GP MDI (PT001), and FF MDI (PT005) compared with Placebo MDI in subjects with moderate to very severe COPD.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	GFF MDI (PT003)	GFF MDI administered as two puffs BID
DRUG	GP MDI (PT001)	GP MDI administered as two puffs BID
DRUG	FF MDI (PT005)	FF MDI administered as two puffs BID
DRUG	Placebo

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2013-05-15
• Last updated: 2017-03-28
• Results posted: 2017-03-28

Locations

113 sites across 1 country: United States