Expired Study
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Chicago, Illinois 60637


Purpose:

The purpose of this study is to evaluate the blood and airway of subjects with mild to moderate COPD while undergoing standard treatment.


Study summary:

Our objective is to examine the mechanism of the additive/synergistic properties of b2-adrenoceptor stimulation and corticosteroid receptor activation in: - Preventing neutrophil adhesion to specific endothelial ligands, e.g. ICAM-1 and - Undergoing activation as a consequence of this adhesion. We hypothesize that combination therapy with salmeterol + fluticasone (FP) will: - Augment the inhibition of adhesion of neutrophils obtained from the peripheral blood of study subjects in vitro, by blocking gIV-PLA2 translocation to the nuclear membrane as for eosinophils; - Augment the inhibition of transendothelial migration of neutrophils into airways of subjects with chronic obstructive pulmonary disease; - Augment the numbers and concentrations of pro-inflammatory products in the bronchoalveolar lavage fluid; and - Decrease the number of neutrophils in the bronchial tissue of endobronchial biopsies of treated patients.


Criteria:

Inclusion Criteria: - Males or females > 50 years of age - Physiologic evidence of COPD defined per ATS guidelines as: cigarette smoking history >20 pack years, FEV1/FVC <70% - Patients must have a post-bronchodilator FEV1 >50% of predicted value at enrollment - Patient must have an O2 saturation measure by pulse oximetry >90% on RA - Must be able to participate in the study, willing to give informed consent, and comply with the study restrictions Exclusion Criteria: - Women of child-bearing potential defined as females who are less than 5 years post menopausal unless they have had a hysterectomy or bilateral oophorectomy - Observation of any solitary nodule in the lung requiring further medical intervention - Patients on maintenance therapy with oral steroids - Patients with giant bullous disease - Significant other medical conditions, which in the opinion of the investigator, will interfere with the patient's ability to perform the study tests - Presence of a coagulopathy as defined by a platelet count <100,000/mm3, and PT and PTT >1.2 x the upper limit of normal - Concurrent enrollment or participation in any other clinical trials within the past 30 days - Primary diagnosis of asthma - History of alpha 1 antitrypsin deficiency - Any clinically significant and active pulmonary disease that could contribute to dyspnea - Current systemic and inhaled steroids and theophylline


NCT ID:

NCT00116402


Primary Contact:

Principal Investigator
Imre Noth, M.D.
University of Chicago


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60637
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 16, 2017

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