Evaluating Genes in Sputum to Measure Drug Response in COPD

This study has been terminated.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
National Jewish Health
ClinicalTrials.gov Identifier:
NCT00233051
First received: October 3, 2005
Last updated: July 19, 2011
Last verified: July 2011
  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:


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
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:
No publications provided

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: July 19, 2011
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:
Bronchitis
Bronchitis, Chronic
Emphysema
Pulmonary Emphysema
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pathologic Processes
Salmeterol
Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 26, 2014