At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating fluticasone propionate/salmeterol 50/250mcg, fluticasone propionate/salmeterol placebo, and 3 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 407 participants across 39 sites.
Detailed Summary
The purpose of this study is to assess the control of COPD using a symptom and exacerbation risk based treatment strategy based on GOLD 2011. This study is conducted in Japanese subjects with COPD and assess whether the GOLD 2011 strategy is effective in medical practice in Japan.
Study Details
Timeline
Interventions
Active, 50/250mcg, Twice daily (morning and evening)
Placebo, Twice daily (morning and evening)
Active, 18mcg, Once daily(morning)
Placebo, Once daily(morning)
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.