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


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Expression of Inflammatory Mediators in Induced Sputum: A Potential Biomarker of Drug Response in COPD

Resource links provided by NLM:

MedlinePlus related topics: Acute Bronchitis Chronic Bronchitis Emphysema Genes and Gene Therapy

Drug Information available for: Salmeterol Fluticasone Salmeterol xinafoate

U.S. FDA Resources

Further study details as provided by National Jewish Health:

Primary Outcome Measures:

Induced Sputum Gene Expression

Secondary Outcome Measures:

Lung Function


Estimated Enrollment:	20
Study Start Date:	April 2003
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	40 Years and older (Adult, Senior)
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

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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 Health

GlaxoSmithKline

Investigators


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

More Information

Additional Information:

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


Responsible Party:	E. Rand Sutherland, MD, MPH, National Jewish Health
ClinicalTrials.gov Identifier:	NCT00233051 History of Changes
Other Study ID Numbers:	HS-1728
Study First Received:	October 3, 2005
Last Updated:	September 24, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by National Jewish Health:


Chronic Obstructive Pulmonary Disease (COPD) Emphysema Chronic Bronchitis Inhaled Steroid Salmeterol

Additional relevant MeSH terms:


Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Bronchitis Emphysema Pulmonary Emphysema Bronchitis, Chronic Respiratory Tract Diseases Bronchial Diseases Respiratory Tract Infections Pathologic Processes Fluticasone Salmeterol Xinafoate Anti-Inflammatory Agents	Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents Anti-Allergic Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2016