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Evaluating Genes in Sputum to Measure Drug Response in COPD

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ClinicalTrials.gov Identifier: NCT00233051
Recruitment Status : Terminated
First Posted : October 5, 2005
Last Update Posted : March 29, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
National Jewish Health

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Emphysema Chronic Bronchitis Drug: Salmeterol or Salmeterol/Fluticasone Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Expression of Inflammatory Mediators in Induced Sputum: A Potential Biomarker of Drug Response in COPD
Study Start Date : April 2003
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Induced Sputum Gene Expression

Secondary Outcome Measures :
  1. Lung Function

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233051


Locations
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United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
GlaxoSmithKline
Investigators
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Principal Investigator: E Rand Sutherland, MD, MPH National Jewish Medical and Research Center Faculty
More Information
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Additional Information:

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Responsible Party: E. Rand Sutherland, MD, MPH, National Jewish Health
ClinicalTrials.gov Identifier: NCT00233051    
Other Study ID Numbers: HS-1728
First Posted: October 5, 2005    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Keywords provided by National Jewish Health:
Chronic Obstructive Pulmonary Disease (COPD)
Emphysema
Chronic Bronchitis
Inhaled Steroid
Salmeterol
Additional relevant MeSH terms:
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Bronchitis
Bronchitis, Chronic
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Emphysema
Emphysema
Respiratory Tract Diseases
Pathologic Processes
Respiratory Tract Infections
Infections
Bronchial Diseases
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