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. )

First Received on June 28, 2006. Last Updated on October 1, 2010 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00346749

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 IV

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:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate

U.S. FDA Resources

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:

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

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
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Salmeterol
Fluticasone
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012