Evaluating Genes in Sputum to Measure Drug Response in COPD
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| ClinicalTrials.gov Identifier: NCT00233051 |
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Recruitment Status :
Terminated
First Posted : October 5, 2005
Last Update Posted : March 29, 2017
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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 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 |
- Induced Sputum Gene Expression
- Lung Function
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| 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.
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
| 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 |
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 |
| First Posted: | October 5, 2005 Key Record Dates |
| Last Update Posted: | March 29, 2017 |
| Last Verified: | March 2017 |
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Chronic Obstructive Pulmonary Disease (COPD) Emphysema Chronic Bronchitis Inhaled Steroid Salmeterol |
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Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Pulmonary Emphysema Bronchitis Bronchitis, Chronic Emphysema 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 |