NCT01854645

Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)

A Randomized, Double Blind, Chronic Dosing, 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 and Spiriva® Handihaler® (Tiotropium Bromide 18 µg Open-Label) as an Active Control

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,103 (actual)
• Sponsor: Pearl Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The overall objective of this study is to assess the efficacy and safety of treatment with PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation powder compared with each other and Placebo MDI over 24 weeks in subjects with moderate to very severe COPD.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	GFF MDI	GFF MDI administered as two puffs Bis in Di.e. Twice Daily (BID)
DRUG	GP MDI	GP MDI administered as two puffs BID
DRUG	FF MDI	FF MDI administered as two puffs BID
DRUG	Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)	Taken as 1 capsule daily containing 18 µg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)
DRUG	Placebo MDI	Inhaled placebo administered as two puffs BID

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2013-05-15
• Last updated: 2017-03-28
• Results posted: 2017-03-28

Locations

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