NCT01587079

Glycopyrrolate/Formoterol Fumarate MDI Compared With Spiriva® as An Active Control in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

A Randomized, Double Blind, (Test Products), Chronic Dosing (7 Days), Four Period, Eight Treatment , Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Five Doses of PT003, One Dose of PT001 and One Dose of PT005 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide 18 µg, Open Label) as Active Control

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Pearl Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate to severe COPD

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	PT003	PT003 MDI administered as two puffs BID for 7 days
DRUG	PT001	PT001 MDI administered as two puffs BID for 7 days
DRUG	PT005	PT005 MDI administered as two puffs BID for 7 days
DRUG	Tiotropium inhalation powder	Taken as 1 capsule containing 18 µg of Tiotropium via the Handihaler DPI for 7 days

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-09-01
• Completion: 2012-10-01
• First posted: 2012-04-27
• Last updated: 2016-06-30
• Results posted: 2016-06-30

Locations

19 sites across 1 country: United States