NCT01566773

PT001 MDI Versus Spiriva® in Patients With Moderate to Severe COPD

A Randomized, Double Blind (Test Products and Placebo), Chronic Dosing (14 Days), Four Period, Eight Treatment, Placebo-Controlled, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Six Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide, Open Label) as An Active Control

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (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 determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.

Detailed description

The primary objective of this study is to assess efficacy relative to placebo of GP MDI in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of GP MDI will be compared to placebo with respect to the primary efficacy endpoint, FEV1 AUC0-12 relative to baseline.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	PT001 MDI	Administered as two puffs BID for 14 days
DRUG	Tiotropium Bromide	Taken as 1 capsule containing 18 µg of tiotropium via the Handihaler DPI
DRUG	PT001 Placebo MDI

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2012-03-29
• Last updated: 2017-10-12
• Results posted: 2017-10-12

Locations

10 sites across 1 country: United States