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

PHASE2CompletedINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

August 1, 2014

Primary Completion Date

March 1, 2015

Study Completion Date

March 1, 2015

Conditions
Chronic Obstructive Pulmonary Disease
Interventions
DRUG

BFF MDI 320/9.6 μg

Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 320/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)

DRUG

BFF MDI 160/9.6 μg

Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 160/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)

DRUG

BFF MDI 80/9.6 μg

Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 80/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)

DRUG

BD MDI 320 μg

Budesonide metered dose inhaler (BD MDI) 320 μg; PT008 administered as 2 inhalations, twice daily (BID)

DRUG

FF MDI 9.6 μg

Formoterol fumarate metered dose inhaler (FF MDI) 9.6 μg; PT005 administered as 2 inhalations, twice daily (BID)

Trial Locations (17)

Unknown

Pearl Investigative Site, Rolling Hills Estates

Pearl Investigative Site, Clearwater

Pearl Investigative Site, Panama City

Pearl Investigative Site, Tampa

Pearl Investigative Site, Winter Park

Pearl Investigative Site, Edina

Pearl Investigative Site, Minneapolis

Pearl Investigative Site, Woodbury

Pearl Investigative Site, Saint Charles

Pearl Investigative Site, Charlotte

Pearl Investigative Site, Cincinnati

Pearl Investigative Site, Columbus

Pearl Investigative Site, Dublin

Pearl Investigative Site, Medford

Pearl Investigative Site, Easley

Pearl Investigative Site, Greenville

Pearl Investigative Site, Spartanburg

Sponsors
All Listed Sponsors
lead

Pearl Therapeutics, Inc.

INDUSTRY