SERETIDE Plus Tiotropium Versus Individual Components
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease
Intervention: Tiotropium + SERETIDE 50/500 (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
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.
Clinical Details
Official title: 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 design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: AUC (0-4hrs, sGAW after morning dose of medication at day 14)
Secondary outcome: 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.
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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 and Contacts
GSK Clinical Trials Call Center, Gent 9000, Belgium
GSK Clinical Trials Call Center, Manchester M23 9LT, United Kingdom
GSK Clinical Trials Call Center, London SE5 9PJ, United Kingdom
GSK Clinical Trials Call Center, Southampton SO16 6YD, United Kingdom
GSK Clinical Trials Call Center, London NW3 2QG, United Kingdom
Additional Information
Starting date: December 2005
Last updated: June 19, 2007
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