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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

NCT01762800 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 407

Last updated 2016-11-10

Study results available
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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.

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01762800 on ClinicalTrials.gov