Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Chronic Obstructive Pulmonary Disease Endpoints Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00358358
First received: July 27, 2006
Last updated: October 26, 2016
Last verified: October 2016
  Purpose
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 Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Fluticasone Propionate/Salmeterol 500/50mcg combination
Drug: Fluticasone Propionate 500mcg
Drug: Salmeterol 50mcg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Peripheral airway resistance measured by IOS [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Airway wall thickness measured by CT scans [ Designated as safety issue: No ]

Enrollment: 163
Study Start Date: March 2006
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
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
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)
  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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: NCT00358358

Locations
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
Study Director: GSK Clinical Trials GlaxoSmithKline
  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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00358358     History of Changes
Other Study ID Numbers: SCO104925 
Study First Received: July 27, 2006
Last Updated: October 26, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
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:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Fluticasone
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Salmeterol Xinafoate
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 06, 2016