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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00361959
First received: August 7, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted
  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 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
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361959

  Show 167 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

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

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bromides
Fluticasone
Salmeterol
Tiotropium
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Anticonvulsants
Autonomic Agents
Bronchodilator Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Dermatologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014