Phase IV O2 Consumption Study in COPD Patients.

PHASE4CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

August 25, 2015

Primary Completion Date

August 12, 2016

Study Completion Date

August 12, 2016

Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
DRUG

Budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg Inhalation aerosol

Subjects will receive a single dose (2 inhalations) of Symbicort pMDI 160/4.5 μg (2 inhalations; total dosage 320/9.0 μg) or placebo (with a spacer) in a cross-over design (a total of 2 doses of Symbicort and 2 doses of placebo over the duration of the study), and assessments will be made before and after dosing at specified timepoints

DRUG

Matching Placebo pMDI 160/4.5 μg

Placebo will be given according at the same dose and schedule as the active comparator - cross-over design.

Trial Locations (5)

19140

Research Site, Philadelphia

28207

Research Site, Charlotte

29303

Research Site, Spartanburg

06105

Research Site, Hartford

02115

Research Site, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY