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.

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Terminated

CT.gov ID

NCT00346749

Collaborator

(none)

180

Enrollment

Locations

Arm

Duration (Months)

16.4

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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)

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Salmeterol Drug: Fluticasone Propionate/Salmeterol Combination Product Other Names: Salmeterol

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: Salmeterol

Drug: Fluticasone Propionate/Salmeterol Combination Product

Other Names:

Salmeterol

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Birmingham	Alabama	United States	35294
2	GSK Investigational Site	Los Angeles	California	United States	90095-1752
3	GSK Investigational Site	San Diego	California	United States	92103
4	GSK Investigational Site	Fort Collins	Colorado	United States	80528
5	GSK Investigational Site	Gainesville	Florida	United States	32610
6	GSK Investigational Site	Decatur	Georgia	United States	30030
7	GSK Investigational Site	Iowa City	Iowa	United States	52242
8	GSK Investigational Site	Durham	North Carolina	United States	27704
9	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19107
10	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19140
11	GSK Investigational Site	Madison	Wisconsin	United States	53792