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Evaluating Genes in Sputum to Measure Drug Response in COPD
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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 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 |
Eligibility| Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00233051
| United States, Colorado | |
| National Jewish Medical and Research Center | |
| Denver, Colorado, United States, 80206 | |
| Principal Investigator: | E Rand Sutherland, MD, MPH | National Jewish Medical and Research Center Faculty |
More Information
Additional Information:
| 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: | March 27, 2017 |
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 Emphysema Pulmonary Emphysema Bronchitis Bronchitis, Chronic Respiratory Tract Diseases Pathologic Processes Bronchial Diseases Respiratory Tract Infections 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 August 18, 2017