NCT01085045 - Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) | Biotech Hunter

Enrollment

118

Participants

Timeline

Start Date

March 31, 2010

Primary Completion Date

November 30, 2010

Study Completion Date

November 30, 2010

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

DRUG

PT003 MDI

Inhaled PT003 MDI administered as two puffs BID for 7 days

DRUG

PT005 MDI

Inhaled PT005 MDI administered as two puffs BID for 7 days

DRUG

Placebo MDI

Inhaled placebo administered as two puffs BID for 7 days

DRUG

Tiotropium bromide 18 μg (Spiriva Handihaler®)

Inhaled tiotropium bromide 18 μg (Spiriva Handihaler®) administered QD for 7 days

DRUG

Formoterol Fumarate 12 μg (Foradil® Aerolizer®)

Inhaled formoterol fumarate 12 μg (Foradil® Aerolizer®) administered BID for 7 days

DRUG

PT001 MDI

Inhaled PT001 MDI administered as two puffs BID for 7 days

Trial Locations (16)

1051

Greenlane Clinical Centre, Epsom

NZ Respiratory & Sleep Institute, Greenlane East

2037

Woolcock, Glebe

2077

Austrials, Hornsby

2229

Austrials, Caringbah

3168

Monash Medical Centre, Clayton

3240

Waikato Hospital, Hamilton

4006

Q-Pharm, Herston

4066

Austrials, Auchenflower

6006

Lung Institute of WA, Nedlands

6143

P3 Research, Crofton Downs

28207

American Health Research, Charlotte

29303

Spartanburg Medical Research, Spartanburg

33765

Clinical Research of West Florida, Inc., Clearwater

97504

Clinical Research Institute of Southern Oregon, PC, Medford

Unknown

Respiratory Research Foundation - Burnside War Memorial Hospital, Adelaide