NCT01762800 - Evaluating the Control of COPD Symptoms in Patients Treated With Tiotropium Bromide 18mcg Once Daily Alone, ADOAIR 50/250mcg Twice Daily Alone or ADOAIR 50/250mcg Plus Tiotropium Bromide 18mcg | Biotech Hunter

Enrollment

407

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

September 30, 2015

Study Completion Date

September 30, 2015

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

fluticasone propionate/salmeterol 50/250mcg

Active, 50/250mcg, Twice daily (morning and evening)

DRUG

fluticasone propionate/salmeterol placebo

Placebo, Twice daily (morning and evening)

DRUG

tiotropium bromide 18mcg

Active, 18mcg, Once daily(morning)

DRUG

tiotropium bromide placebo

Placebo, Once daily(morning)

DRUG

fluticasone propionate/salmeterol 50/250mcg and tiotropium 18mcg

Active. The randomized treatment may be switched to TRIPLE therapy when COPD symptoms are uncontrolled or the subject is not satisfied with the randomized treatment at each scheduled or unscheduled visit.

Trial Locations (39)

814-0180

GSK Investigational Site, Fukuoka

816-0813

GSK Investigational Site, Fukuoka

720-0001

GSK Investigational Site, Hiroshima

734-8530

GSK Investigational Site, Hiroshima

737-0023

GSK Investigational Site, Hiroshima

737-0811

GSK Investigational Site, Hiroshima

070-8644

GSK Investigational Site, Hokkaido