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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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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
| ClinicalTrials.gov Identifier: | NCT00361959 History of Changes |
| Other Study ID Numbers: | SCO40036 |
| Study First Received: | August 7, 2006 |
| Last Updated: | August 7, 2006 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
COPD exacerbation fluticasone propionate/salmeterol combination SERETIDE tiotropium |
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Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Bromides Salmeterol Fluticasone Tiotropium Fluticasone, salmeterol drug combination Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Adrenergic beta-2 Receptor Agonists |
Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents Parasympatholytics |