NCT01349803

PT003 MDI Cardiovascular Safety Study

A Randomized, Double-blind, Parallel Group, 14-day, Multi-Center Study to Evaluate the Safety of PT003, PT005, PT001 and Foradil® Aerolizer® (12 µg, Open Label) as Evaluated by Holter Monitoring, in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 237 (actual)
• Sponsor: Pearl Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is primarily a safety study. The primary and secondary endpoints are based on 24-hour Holter monitor assessments obtained on Day 14 relative to baseline.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	PT005 MDI	PT005 MDI administered as two puffs BID for 14 days
DRUG	PT001 MDI	PT001 MDI administered as two puffs BID for 14 days
DRUG	PT003 MDI	PT003 MDI administered as two puffs BID for 14 days
DRUG	Formoterol Fumarate 12 μg (Foradil® Aerolizer®)	Formoterol Fumarate 12 μg (Foradil® Aerolizer®) administered BID for 14 days

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2011-05-09
• Last updated: 2017-01-31
• Results posted: 2017-01-31

Locations

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