NCT01350128

PT001 MDI Versus Atrovent Study in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

A Randomized, Double-Blind, Chronic Dosing (7 Days), Three-Period, Six-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Four Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Atrovent® HFA Inhalation Aerosol (Open-Label) as An Active Control

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 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 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 demonstrate efficacy relative to placebo of PT001 MDI in patients with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of PT001 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	PT001 MDI administered as two puffs BID for 7 days
DRUG	Ipratropium Bromide HFA Inhalation Aerosol	Taken as 2 inhalations of the 17 µg per actuation strength MDI QID
OTHER	Placebo MDI	Matching placebo to PT001 MDI administered as two puffs BID for 7 days

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-05-09
• Last updated: 2018-06-20
• Results posted: 2017-06-08

Locations

8 sites across 1 country: United States