Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Randomised, Double-blind, Double Dummy, 3 Way Cross-over Study Evaluating the Effects of ADOAIR 50/250mcg Twice Daily Plus Tiotropium Bromide 18mcg Once Daily Compared With the Individual Treatments (Tiotropium Bromide 18mcg Alone and ADOAIR 50/250mcg Alone) in the Treatment of Japanese Subjects With COPD
The purpose of this study is to evaluate the effects on lung function of a combination of
ADOAIR 50/250mcg twice daily plus tiotropium bromide 18mcg once daily compared with the
individual treatments (tiotropium bromide 18mcg once daily alone and ADOAIR 50/250mcg twice
daily alone) in Japanese subjects with COPD. The study will utilize a three-way cross-over
design with a 2-week wash-out period between each 4-week consecutive treatment period. The
aim is to support the rationale for "triple combination" therapy by demonstrating that
treatment with both ADOAIR and tiotropium can potentially produce improved, clinically
relevant effects compared with either treatment alone.
This study will utilize a range of lung function measures in order to fully assess the
benefits of triple therapy. The primary endpoint will be based on airways conductance
measured using plethysmography (sGaw measured over 4hours post dose (AUC 0-4hr) on Day 28).
Secondary endpoints will include lung function measures based on plethysmography and
spirometry. The lung function measures will be supported by measurement of the use of relief
salbutamol .
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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