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

ADVAIR DISKUS® (Fluticasone Propionate/Salmeterol) Inhaler Versus SEREVENT DISKUS® (Salmeterol) Inhlaer On Inflammatory Cells And Markers In Chronic Obstructive Pulmonary Disease. ADVAIR DISKUS® and SEREVENT DISKUS® Inhalers Are Trademarks of the GSK Group of Companies.

This study has been terminated.
(The study was terminated due to difficulties with finding sites and subjects willing to participate.)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00346749
First received: June 28, 2006
Last updated: October 27, 2016
Last verified: October 2016
  Purpose
This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). The study will last 12 weeks. At the end of 12 weeks of treatment, subjects will stop the study medicines for 2 weeks. The study will involve 6 visits to the clinic. Subjects who elect to undergo bronchoalveolar lavage (BAL) procedures will have 8 study visits. Subjects will give sputum, blood, and in some cases BAL samples. Subjects will have breathing tests and will complete diary cards during the study. All study medicines and examinations will be given at no cost to the study subjects. Both medicines used in this study have been approved by the US FDA.

Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Salmeterol
Drug: Fluticasone Propionate/Salmeterol Combination Product
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group, 12-Week Study to Evaluate the Anti-Inflammatory Effect of Fluticasone Propionate/Salmeterol DISKUS 250/50mcg BID Compared With Salmeterol DISKUS 50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Percent of sputum neutrophils

Secondary Outcome Measures:
  • Inflammation endpoints: Cell counts in sputum, cell counts and protein markers in BAL, protein markers in blood Clinical endpoints: FEV1 Airway conductance and airway resistance Functional residual capacity Shortness of breath symptoms

Estimated Enrollment: 180
Study Start Date: December 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Salmeterol Drug: Fluticasone Propionate/Salmeterol Combination Product
Other Name: Salmeterol

  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.
  • Pre-bronchodilator FEV1 less than or equal to 70.0% and greater than or equal to 0.70L
  • Ex-Smokers with at least a 10 pack-year history.

Exclusion Criteria:

  • Current of secondary diagnosis of asthma or current diagnosis of atopy.
  • Other respiratory disorders other than COPD.
  • Other inflammatory diseases.
  • Abnormal and clinically significant chest x-ray or ECG.
  • Lung resection surgery within past 1 year.
  • History of cancer not in remission within past 2 years.
  • Serious, uncontrolled disease.
  • Pregnancy or planning to become pregnant during the study.
  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: NCT00346749

Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35294
United States, California
GSK Investigational Site
Los Angeles, California, United States, 90095-1752
GSK Investigational Site
San Diego, California, United States, 92103
United States, Colorado
GSK Investigational Site
Fort Collins, Colorado, United States, 80528
United States, Florida
GSK Investigational Site
Gainesville, Florida, United States, 32610
United States, Georgia
GSK Investigational Site
Decatur, Georgia, United States, 30030
United States, Iowa
GSK Investigational Site
Iowa City, Iowa, United States, 52242
United States, North Carolina
GSK Investigational Site
Durham, North Carolina, United States, 27704
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
United States, Wisconsin
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
This study has not been published in the scientific literature.

Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: ADC105931
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: ADC105931
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: ADC105931
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: ADC105931
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: ADC105931
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: ADC105931
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00346749     History of Changes
Other Study ID Numbers: ADC105931 
Study First Received: June 28, 2006
Last Updated: October 27, 2016
Health Authority: Canada: Health Canada
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:
Inflammation
FEV1
Sputum

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Fluticasone
Salmeterol Xinafoate
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics

ClinicalTrials.gov processed this record on December 07, 2016