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Therapeutic Areas: Pulmonary/Respiratory Diseases | Trauma/Emergency Medicine | Immunology/Infectious Diseases
Disease Category: COPD (Chronic Obstructive Pulmonary Disease)

Trial Information

This is a phase III trial evaluating 2 dose levels, twice daily of an investigational drug versus placebo in the treatment of moderate to severe chronic obstructive pulmonary disease or COPD.

The trial consists of a 2 week run in period followed by a 12 week treatment plan. The trial will require a minimum 7 clinic visits and a follow up phone call 2 weeks after your final clinic visit. Study procedures include physical examinations, vital signs, EKGs, pulmonary function tests, laboratory testing, questionnaires 24 hour holter monitoring and use of an electronic diary.

INCLUSION:

• Male or Female 40 years of age or greater
• Current or former smokers with at least a 10 pack year history
• Diagnosis of moderate to stable COPD

EXCLUSION:

• Hospitalization for a COPD exacerbation within 3 months of Visit 1
• Chronic use of Oxygen (Greater than 15 hours a day)
• Drug or alcohol abuse within the previous 5 years
• Patients with any serious uncontrolled physical or mental condition that could place the patient at higher risk
• Patients with hypersensitivity to inhaled anticholinergics
• Patients who are pregnant or breast-feeding

Jessica Elkins RN, CCRC, Director Of Clinical Research
Emerald Coast Research Associates
221 East 23rd Street Suite B
Panama City, FL 32405
Phone: (850) 785-6550

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