Advair® DISKUS® (Fluticasone Propionate/Salmeterol) Versus Serevent® DISKUS® (Salmeterol) For The Treatment Of Chronic Obstructive Pulmonary Disease Exacerbations - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00144911

Purpose

This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the clinic 10 times. Subjects will be given breathing tests and will record their breathing symptoms daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The two drugs used in this study have been approved by the FDA for use in patients with COPD.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: Salmeterol Drug: Fluticasone Propionate/Salmeterol Combination Product	Phase IV

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Fluticasone Fluticasone propionate Salmeterol Salmeterol xinafoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Rate of moderate/severe exacerbations over a 52 week treatment period.

Secondary Outcome Measures:

The time until the first moderate/severe exacerbation, the annual rate of exacerbations requiring oral corticosteroid treatment, and breathing tests conducted over one year.

Estimated Enrollment:	740
Study Start Date:	October 2004

Detailed Description:

A Randomized, Double-Blind, Parallel Group, 52-week Study to Compare the Effect of the Fluticasone Propionate/Salmeterol DISKUS Combination Product 250/50mcg BID with Salmeterol DISKUS 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of COPD (chronic obstructive pulmonary disease).
Current or previous cigarette smokers with a smoking history of at least 10 pack-years.
History of a least 1 COPD exacerbation in the 12 months prior to screening.
Forced expiratory volume in one second (FEV1) of less than or equal to 50% of predicted normal.

Exclusion Criteria:

Current diagnosis of asthma.
Additional respiratory disorders other than COPD (eg, sarcoidosis, alpha-1 antitrypsin deficiency, cystic fibrosis, or active tuberculosis).
Concurrent use of long-acting beta-agonists, long-acting anticholinergics, inhaled and oral corticosteroids, theophylline, investigational medications, ritonavir, and anti-leukotrienes.
Lung resection surgery within 1 year of screening.
Abnormal and clinically significant ECG findings at screening.
Other inclusion and exclusion criteria will be evaluated at the first study visit.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144911

Show 95 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SCO40043
Study First Received:	September 1, 2005
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00144911
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

exacerbations
chronic obstructive pulmonary disease
breathing

Study placed in the following topic categories:

Lung Diseases, Obstructive
Salmeterol
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Fluticasone
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents

Anti-Allergic Agents
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009