A Pilot Study of the Mechanism of Synergism Between FP and Salmeterol in Preventing COPD Exacerbations

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborator: GlaxoSmithKline
• Treatments: Fluticasone; Salmeterol Xinafoate

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