Evaluating Genes in Sputum to Measure Drug Response in COPD - Full Text View

Purpose

The purpose of this research study is to determine whether analysis of genes in sputum is a useful noninvasive technique for measuring response to drugs in patients with COPD.

We propose to use polymerase chain reaction to evaluate gene expression in induced sputum from adult current smokers with moderate COPD, adult former smokers with moderate COPD. This study is designed to determine whether changes in expression of previously-identified inflammatory markers in induced sputum can be detected in response to drug therapy in COPD and to evaluate potential differences in the expression of these markers in adult smokers with and without COPD. Pre- and post-treatment serum will be obtained to facilitate proteomic analysis of therapeutic response as well. Changes in sputum gene expression in response to treatment will be the primary outcome variable in this study. Secondary outcomes will include changes in lung function, as well as changes in induced sputum inflammation. These endpoints will be evaluated before and directly after 6 weeks of randomly-assigned treatment with either salmeterol xinafoate or fluticasone propionate/50mcg salmeterol xinafoate combination DPI bid. Endpoints will be re-evaluated following a 4 week wash-out period.

Condition	Intervention
Chronic Obstructive Pulmonary Disease (COPD) Emphysema Chronic Bronchitis	Drug: Salmeterol or Salmeterol/Fluticasone

MedlinePlus related topics:

Bronchitis COPD (Chronic Obstructive Pulmonary Disease) Emphysema

ChemIDplus related topics:

Fluticasone propionate Fluticasone Salmeterol Salmeterol xinafoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Expression of Inflammatory Mediators in Induced Sputum: A Potential Biomarker of Drug Response in COPD

Further study details as provided by National Jewish Medical and Research Center:

Primary Outcome Measures:

Induced Sputum Gene Expression

Secondary Outcome Measures:

Lung Function

Estimated Enrollment:	20
Study Start Date:	April 2003

Eligibility

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

Criteria

Inclusion Criteria:

Twenty adult subjects ≥ 40 years of age and ≥ 10 pack/year cigarette history will be evaluated.
Subjects will be recruited such that one-half are current smokers and one-half are former smokers.
All subjects will have COPD (FEV1/FVC < 70% and FEV1 => 40% predicted).
Airway hyperresponsiveness and diffusion capacity for carbon monoxide will also be performed to more precisely characterize the physiologic phenotype in these subjects.

Exclusion Criteria:

Subjects will be excluded if they have used inhaled or systemic corticosteroid or antibiotic use within 6 weeks or if they are currently treated with theophylline.
A 6 weeks run off after an upper respiratory infection will be required for qualifying subjects.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233051

Locations


United States, Colorado
	National Jewish Medical and Research Center
	Denver, Colorado, United States, 80206

Sponsors and Collaborators

National Jewish Medical and Research Center

GlaxoSmithKline

Investigators


Principal Investigator:	E Rand Sutherland, MD, MPH	National Jewish Medical and Research Center Faculty

More Information

clinical lab website within National Jewish Medical and Research Center This link exits the ClinicalTrials.gov site

Study ID Numbers:	HS-1728
First Received:	October 3, 2005
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00233051
Health Authority:	United States: Institutional Review Board

Keywords provided by National Jewish Medical and Research Center:

Chronic Obstructive Pulmonary Disease (COPD)

Emphysema

Chronic Bronchitis

Inhaled Steroid

Salmeterol

Study placed in the following topic categories:

Pulmonary Emphysema

Emphysema

Bronchitis, Chronic

Lung Diseases, Obstructive

Salmeterol

Respiratory Tract Infections

Respiratory Tract Diseases

Lung Diseases

Fluticasone

Bronchitis

Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Respiratory System Agents

Neurotransmitter Agents

Bronchial Diseases

Adrenergic beta-Agonists

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Anti-Asthmatic Agents

Anti-Allergic Agents

Adrenergic Agonists

Pharmacologic Actions

Pathologic Processes

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Dermatologic Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on October 03, 2008

Sponsors and Collaborators:	National Jewish Medical and Research Center GlaxoSmithKline
Information provided by:	National Jewish Medical and Research Center
ClinicalTrials.gov Identifier:	NCT00233051