SERETIDE 50/500mcg Versus Tiotropium Bromide On Exacerbation Rates In Severe Chronic Obstructive Pulmonary Disease

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: August 7, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted
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 4

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)

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Rate of healthcare utilisation based exacerbations of COPD

Secondary Outcome Measures:
  • Rates for exacerbations based on symptoms, treatment with oral corticosteroids and for antibiotics Time to next exacerbation, duration and difference between healthcare utilisation and symptom based exacerbation

Estimated Enrollment: 1270
Study Start Date: September 2003

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Established clinical history of moderate to severe COPD.
  • Post bronchodilator FEV1 of < 50% of predicted normal.
  • FEV1 / FVC ratio <70%.
  • Reversibility to 400mcg albuterol of less or equal to 10 predicted at Visit 1.
  • Free from exacerbation in the 6 weeks prior to screening.
  • Current or former smoker with a smoking history of = 10 pack-years and has a history of COPD exacerbations.

Exclusion criteria:

  • Current asthma, eczema, atopic dermatitis and/or allergic rhinitis.
  • Has a known respiratory disorder other than COPD (e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis).
  • Has narrow-angle glaucoma, prostatic hyperplasia or obstruction of the neck of the bladder that in the opinion of the investigator should prevent the subject from entering the study.
  • Has undergone lung transplantation and/or lung volume reduction.
  • Female who is a nursing mother.
  • Requires regular (daily) long-term oxygen therapy (LTOT).
  • Is receiving beta-blockers (except eye drops).
  • Has a serious, uncontrolled disease likely to interfere with the study.
  • Has received any other investigational drugs within the 4 weeks prior to Visit 1.
  • Has, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
  • Has a known or suspected hypersensitivity to beta2-agonists, inhaled corticosteroids, anticholinergic agents or any components of the formulations (e.g. lactose or milk protein).
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Please refer to this study by its identifier: NCT00361959

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Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): 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

Keywords provided by GlaxoSmithKline:
COPD exacerbation
fluticasone propionate/salmeterol combination

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Salmeterol Xinafoate
Tiotropium Bromide
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Cholinergic Agents
Hormones processed this record on August 29, 2016