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Sponsored by: |
Gelb, Arthur F., M.D. |
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Information provided by: | Gelb, Arthur F., M.D. |
ClinicalTrials.gov Identifier: | NCT00569348 |
To evaluate the role of inhaled corticosteroids to suppress nitric oxide gas exchange in stable patients with moderate-to-severe COPD who are current non-smokers and not on oral corticosteroids.
Condition | Intervention |
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COPD |
Drug: fluticasone 100mcg/salmeterol 50mcg Drug: fluticasone 250/salmeterol 50 |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Single Blind (Outcomes Assessor), Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | Evaluation of the Effects of Varying Doses of Inhaled Corticosteroids on Suppression of Total Exhaled, Bronchial, and Alveolar Nitric Oxide as Markers of Endogenous Inflammation in Patients With Moderate-to-Severe COPD |
Enrollment: | 39 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: No Intervention
salmeterol only, no fluticasone
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B: Active Comparator
fluticasone 250mcg/salmeterol 50 mcg bid X 3momths
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Drug: fluticasone 250/salmeterol 50
inhaled fluticasone 250/salmeterol 50 X 3 months
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C: Active Comparator
Fluticasone 100mcg/salmeterol 50mcg
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Drug: fluticasone 100mcg/salmeterol 50mcg
inhaled fluticasone 100mcg/salmeterol 50mcg bid X 3 months
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Stable, non-smoking COPD patients not on oral corticosteroids will be randomized in single blinded study to evaluate nitric oxide gas exchange at baseline, and subsequent effects of fluticasone 100mcg/salmeterol 50mcg bid, and fluticasone 250mcg/salmeterol 50mcg bid. Primary end points will include measurements of nitric oxide at varying expiratory flow rates to calculate bronchial, and small airway/alveolar nitric oxide. Secondary end points will evaluate lung function. Exhaled nitric oxide production presumably reflects endogenous inflammation. Normal healthy, non-smoking controls will be used for comparison, with exhaled nitric oxide measured before and after 3 weeks of low dose inhlaed corticosteroids.
Ages Eligible for Study: | 40 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Arthur F Gelb MD | |
Lakewood, California, United States, 90712 | |
Arthur F Gelb MD | |
Lakewood, California, United States, 90712 |
Principal Investigator: | Arthur F Gelb, MD | Arthur F Gelb Medical Corporation |
Responsible Party: | Arthur F. Gelb MD ( Arthur F. Gelb MD ) |
Study ID Numbers: | 20061697 |
Study First Received: | December 5, 2007 |
Last Updated: | January 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00569348 |
Health Authority: | United States: Institutional Review Board |
chronic airflow obstruction |
Nitric Oxide Salmeterol Fluticasone Inflammation |
Anti-Inflammatory Agents Respiratory System Agents Vasodilator Agents Neurotransmitter Agents Antioxidants Adrenergic Agents Adrenergic beta-Agonists Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents Anti-Allergic Agents |
Cardiovascular Agents Protective Agents Adrenergic Agonists Pharmacologic Actions Autonomic Agents Therapeutic Uses Free Radical Scavengers Endothelium-Dependent Relaxing Factors Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents |