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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: | April 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: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00116402 |
Health Authority: | United States: Institutional Review Board |
COPD Chronic Obstructive Pulmonary Disease |
Inhaled Corticosteroids Airway Inflammation Bronchoscopy |
Lung Diseases, Obstructive Salmeterol Respiratory Tract Diseases Lung Diseases Respiration Disorders |
Fluticasone Chronic Disease Inflammation Pulmonary Disease, Chronic Obstructive |
Anti-Inflammatory Agents Respiratory System Agents Disease Attributes Neurotransmitter Agents Adrenergic beta-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents |
Anti-Allergic Agents Adrenergic Agonists Pharmacologic Actions Pathologic Processes Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents |