NCT01970878

Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® (PINNACLE 3)

A 28-Week, Multi-Center, Randomized, Double Blind, Parallel-Group, Active-Controlled Safety Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® as an Active Control

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 892 (actual)
• Sponsor: Pearl Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double-blind, parallel group, chronic dosing, active-controlled, 28-week safety extension study of the two pivotal 24-week safety and efficacy studies (Studies PT003006 and PT003007). This study is designed to assess the long-term safety and tolerability of Glycopyrrolate (GP) and Formoterol Fumarate (FF) combination (GFF) metered dose inhaler (MDI), GP MDI, and FF MDI in subjects with moderate to very severe COPD over a total observation period of 52 weeks. Open-label Spiriva is included as an active control. To be eligible for this study, a subject must complete participation in Study PT003006 (NCT01854645) or Study PT003007 (NCT01854658).

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	GFF MDI (PT 003)	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	Open-label tiotropium bromide inhalation (Spiriva® Handihaler®)	Taken as 1 capsule daily containing 18 μg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2013-10-28
• Last updated: 2017-03-17
• Results posted: 2017-02-06

Locations

125 sites across 3 countries: United States, Australia, New Zealand