ADVAIR DISKUS (Fluticasone Propionate/Salmeterol) Versus SEREVENT DISKUS (Salmeterol) On Inflammatory Cells And Markers In Chronic Obstructive Pulmonary Disease

This study has been terminated.
(The study was terminated due to difficulties with finding sites and subjects willing to participate.)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00346749
First received: June 28, 2006
Last updated: October 1, 2010
Last verified: October 2010
  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
Chronic Obstructive Pulmonary Disease (COPD)
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
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 BID 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)
Intervention Details:
    Drug: Salmeterol Drug: Fluticasone Propionate/Salmeterol Combination Product
    Other Names:
    • Salmeterol
    • Fluticasone Propionate/Salmeterol Combination Product
  Eligibility

Ages Eligible for Study:   40 Years and older
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, 19140
United States, Wisconsin
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00346749     History of Changes
Other Study ID Numbers: ADC105931
Study First Received: June 28, 2006
Last Updated: October 1, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by GlaxoSmithKline:
Inflammation
FEV1
Sputum

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

ClinicalTrials.gov processed this record on October 30, 2014