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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00361959 |
Purpose
This is a comparator study to assess the relative efficacy of the combination product fluticasone propionate/salmeterol 50/500 and tiotropium bromide on the rate of exacerbations of chronic obstructive pulmonary disease (COPD) over a two year study interval.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: Tiotropium bromide 18mcg Drug: Fluticasone propionate/ salmeterol combination 50/500mcg |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multicentre, Randomised, Double-Blind, Double Dummy, Parallel Group, 104 Week Study to Compare the Effect of the Salmeterol/Fluticasone Propionate Combination Product (SERETIDE) 50/500mcg With Tiotropium Bromide 18 Mcg on the Rate of Exacerbations in Subjects With Severe Chronic Obstructive Pulmonary Disease (COPD) |
| Estimated Enrollment: | 1270 |
| Study Start Date: | September 2003 |
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
Show 167 Study Locations| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Study ID Numbers: | SCO40036 |
| Study First Received: | August 7, 2006 |
| Last Updated: | August 7, 2006 |
| ClinicalTrials.gov Identifier: | NCT00361959 History of Changes |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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COPD exacerbation fluticasone propionate/salmeterol combination SERETIDE tiotropium |
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Anti-Inflammatory Agents Parasympatholytics Respiratory System Agents Neurotransmitter Agents Cholinergic Antagonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cholinergic Agents Adrenergic Agonists Lung Diseases, Obstructive Respiratory Tract Diseases Bromides Therapeutic Uses Fluticasone |
Tiotropium Dermatologic Agents Salmeterol Adrenergic beta-Agonists Respiration Disorders Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Autonomic Agents Lung Diseases Peripheral Nervous System Agents Central Nervous System Agents Bronchodilator Agents Anticonvulsants Pulmonary Disease, Chronic Obstructive |