Overview

Efficacy and Safety Study of PT009, PT008, and PT005 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Status:
Completed

Trial end date:
2015-03-01

Target enrollment:

Participant gender:

Summary

This is a Phase IIb, randomized, double blind, chronic dosing (28 days), four period, five treatment, incomplete block, crossover design in subjects with moderate to severe COPD. The overall objective is to demonstrate that the combination of budesonide (BD; PT008) and formoterol fumarate (FF; PT005) in a metered-dose inhaler (MDI); (BFF MDI; PT009) provides benefit on lung function compared with BD MDI in subjects with moderate to severe COPD.

Phase:

Phase 2

Details

Lead Sponsor:

Pearl Therapeutics, Inc.

Treatments:

Budesonide
Formoterol Fumarate