Status:
COMPLETED
A Pilot Study of the Mechanism of Synergism Between FP and Salmeterol in Preventing COPD Exacerbations
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the blood and airway of subjects with mild to moderate COPD while undergoing standard treatment.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00116402
Start Date
January 1 2005
End Date
October 1 2009
Last Update
August 5 2014
Active Locations (1)
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1
Department of Medicine, Pulmonary & Critical Care Section, The University of Chicago
Chicago, Illinois, United States, 60637