SERETIDE Plus Tiotropium Versus Individual Components

GlaxoSmithKline41 enrolled

Overview

This study was designed to evaluate the effects on lung function of a combination of SERETIDE 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments (tiotropium bromide 18mcg once daily alone and SERETIDE 50/500mcg twice daily alone) in subjects with COPD. The study will utilise a three-way cross-over design with a 2-week wash-out period between each 2-week consecutive treatment period.

A randomised, double-blind, double dummy, 3 way cross-over study evaluating the effects of SERETIDE™ 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments (tiotropium bromide 18mcg alone and SERETIDE 50/500mcg alone) in the treatment of subjects with COPD

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium + SERETIDE 50/500DRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Has an established clinical history of COPD as defined as per the GOLD definition. * Post-bronchodilator FEV1 of \>30% to 75% of predicted normal at Visit 1, a post-bronchodilator FEV1 / FVC ratio = 70%. * Current or ex-smoker with a smoking history of \> 10 pack-years. Exclusion Criteria: * Has unstable COPD (Chronic Obstructive Pulmonary Disease). * Has a current medical diagnosis of asthma and/or allergic rhinitis or know respiratory disorders (lung cancer, sarcoidosis, tuberculosis or lung fibrosis) Requires regular (daily) or long term oxygen therapy (LTOT). (LTOT is defined as \> 12 hours oxygen use per day).

Locations (5)

GSK Investigational Site

Ghent, Belgium

GSK Investigational Site

Southampton, Hampshire, United Kingdom

GSK Investigational Site

Manchester, Lancashire, United Kingdom

GSK Investigational Site

London, United Kingdom

Outcomes

Primary Outcomes

AUC (0-4hrs, sGAW after morning dose of medication at day 14)

Secondary Outcomes

Effects of SERETIDE 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments on further elements of lung function, dyspnoea, symptoms and a patient/physician assessment of treatment effect.

Data from ClinicalTrials.gov

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