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Sponsors and Collaborators: |
University of Chicago GlaxoSmithKline |
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Information provided by: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00116402 |
The purpose of this study is to evaluate the blood and airway of subjects with mild to moderate COPD while undergoing standard treatment.
Condition | Intervention |
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Pulmonary Disease, Chronic Obstructive |
Drug: fluticasone and salmeterol |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Efficacy Study |
Official Title: | A Pilot Study of the Mechanism of Synergism Between Fluticasone (FP) and Salmeterol in Preventing Chronic Obstructive Pulmonary Disease (COPD) Exacerbations |
Estimated Enrollment: | 14 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
will start with fluticasone 220 mcg BID first and then crossover to combination therapy with salmeterol 50 mcg BID
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Drug: fluticasone and salmeterol
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2: Active Comparator
salmeterol 50 mcg BID then crossover to combination therapy with fluticasone 220 mcg BID
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Drug: fluticasone and salmeterol
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Our objective is to examine the mechanism of the additive/synergistic properties of b2-adrenoceptor stimulation and corticosteroid receptor activation in:
We hypothesize that combination therapy with salmeterol + fluticasone (FP) will:
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Imre Noth, M.D. | 773-834-1832 | inoth@medicine.bsd.uchicago.edu |
United States, Illinois | |
Department of Medicine, Pulmonary & Critical Care Section, The University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Imre Noth, M.D. 773-834-1832 inoth@medicine.bsd.uchicago.edu | |
Contact: Alan Leff, M.D. 773-702-3609 aleff@medicine.bsd.uchicago.edu | |
Principal Investigator: Imre Noth, M.D. | |
Sub-Investigator: Alan Leff, M.D. |
Principal Investigator: | Imre Noth, M.D. | University of Chicago |
Responsible Party: | University of Chicago ( Imre Noth, MD ) |
Study ID Numbers: | 13426B |
Study First Received: | June 28, 2005 |
Last Updated: | April 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00116402 History of Changes |
Health Authority: | United States: Institutional Review Board |
COPD Chronic Obstructive Pulmonary Disease |
Inhaled Corticosteroids Airway Inflammation Bronchoscopy |
Anti-Inflammatory Agents Neurotransmitter Agents Salmeterol Adrenergic Agents Adrenergic beta-Agonists Respiration Disorders Anti-Asthmatic Agents Anti-Allergic Agents Adrenergic Agonists |
Inflammation Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Fluticasone Chronic Disease Peripheral Nervous System Agents Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |
Anti-Inflammatory Agents Respiratory System Agents Disease Attributes Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic Agonists Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Diseases Therapeutic Uses Fluticasone |
Dermatologic Agents Salmeterol Adrenergic beta-Agonists Respiration Disorders Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Autonomic Agents Lung Diseases Chronic Disease Peripheral Nervous System Agents Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |