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Chronic Obstructive Pulmonary Disease Endpoints Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00358358
Recruitment Status : Completed
First Posted : July 31, 2006
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
This study will last for approximately 14 weeks and will involve 5 visits. The study is being carried out to look at different ways of measuring the effect of drug treatment on COPD. COPD is a respiratory disease which can affect your breathing and daily life. Symptoms of COPD can include breathlessness, cough, and wheeze. COPD varies enormously from patient to patient. The effects of drug treatment are usually measured by conducting lung function tests (breathing tests) using a machine called a spirometer but this does not always provide a complete picture of how well your COPD is responding. In this study we therefore want to look at new and more sensitive ways of measuring COPD. The results of this research will help in the assessment of new drugs for COPD in the future.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Fluticasone Propionate/Salmeterol 500/50mcg combination Drug: Fluticasone Propionate 500mcg Drug: Salmeterol 50mcg Phase 4

Detailed Description:
Evaluation of Novel Endpoints in Subjects with Chronic Obstructive Pulmonary Disease (COPD) in a Randomized, Double-Blind, Placebo-Controlled Study of Treatment with Fluticasone Propionate/Salmeterol 500/50mcg combination (FSC 500/50) and its individual components, Fluticasone Propionate 500mcg (FP500) and Salmeterol 50mcg (SAL 50)
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Placebo-controlled Study of Treatments With Salmeterol, Fluticasone Propionate and Their Combination to Evaluate Novel Endpoints in Patients With Chronic Obstructive Pulmonary Disease
Study Start Date : March 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
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Intervention Details:
  • Drug: Fluticasone Propionate/Salmeterol 500/50mcg combination
  • Drug: Fluticasone Propionate 500mcg
  • Drug: Salmeterol 50mcg
    Other Names:
    • Fluticasone Propionate/Salmeterol 500/50mcg combination
    • Fluticasone Propionate 500mcg

Outcome Measures
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Primary Outcome Measures :
  1. Peripheral airway resistance measured by IOS

Secondary Outcome Measures :
  1. Airway wall thickness measured by CT scans

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Diagnosis of COPD
  • Current or ex-smoker at least 10 pack- years

Exclusion criteria:

  • Diagnosis of asthma
  • Active respiratory disorder other than COPD
  • Evidence of clinically significant uncontrolled non-pulmonary disease
  • Carcinoma not in complete remission for last 5 years
  • Lung volume reduction surgery in previous 12 months
  • Nocturnal positive pressure for sleep apnea
  • Other inclusion and exclusion criteria will be evaluated at the first study visit.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358358


Locations
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United States, New Jersey
GSK Investigational Site
Absecon, New Jersey, United States, 8201
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29406-7108
GSK Investigational Site
Greenville, South Carolina, United States, 29615
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Chile
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500691
GSK Investigational Site
Valparaiso, Valparaíso, Chile, 2341131
Estonia
GSK Investigational Site
Tartu, Estonia, 51014
Russian Federation
GSK Investigational Site
Barnaul, Russian Federation, 656 045
GSK Investigational Site
Moscow, Russian Federation, 105 077
GSK Investigational Site
Moscow, Russian Federation, 105 229
GSK Investigational Site
Nizhnekamsk, Russian Federation, 423570
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: SCO104925
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: SCO104925
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: SCO104925
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: SCO104925
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: SCO104925
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: SCO104925
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: SCO104925
For additional information about this study please refer to the GSK Clinical Study Register

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

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00358358    
Other Study ID Numbers: SCO104925
First Posted: July 31, 2006    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Keywords provided by GlaxoSmithKline:
COPD
Impulse Oscillometry System
Computerized Tomography
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Fluticasone
Salmeterol Xinafoate
Fluticasone-Salmeterol 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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics