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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.

NCT ID: NCT00346749

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Keywords

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Inflammation FEV1 Sputum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Salmeterol

Intervention Type DRUG

Fluticasone Propionate/Salmeterol Combination Product

Intervention Type DRUG

Interventions

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Salmeterol

Intervention Type DRUG

Fluticasone Propionate/Salmeterol Combination Product

Intervention Type DRUG

Other Intervention Names

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Salmeterol

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

Site Status

GSK Investigational Site

Los Angeles, California, United States

Site Status

GSK Investigational Site

San Diego, California, United States

Site Status

GSK Investigational Site

Fort Collins, Colorado, United States

Site Status

GSK Investigational Site

Gainesville, Florida, United States

Site Status

GSK Investigational Site

Decatur, Georgia, United States

Site Status

GSK Investigational Site

Iowa City, Iowa, United States

Site Status

GSK Investigational Site

Durham, North Carolina, United States

Site Status

GSK Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

GSK Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

GSK Investigational Site

Madison, Wisconsin, United States

Site Status

Countries

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Argentina Canada United States

References

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This study has not been published in the scientific literature.

Reference Type BACKGROUND

Study Documents

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Document Type: Dataset Specification

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Clinical Study Report

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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ADC105931

Identifier Type: -

Identifier Source: org_study_id