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28-day Repeat Dose Study of GSK573719 - NCT01030965-28207(Clinical Trial 463289)



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City:  Charlotte
State:  
NC
Zip Code: 28207
Conditions: Chronic Bronchitis - Emphysema - Pulmonary Disease, Chronic Obstructive
Purpose: The study will evaluate the efficacy, safety, and pharmacokinetics of GSK573719 compared with placebo in subjects with COPD
Study summary: This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate 3 doses of GSK573719 administered once-daily over 28 days in subjects with COPD.
Criteria: Inclusion Criteria: - A signed and dated written informed consent prior to study participation - Males or females of non-childbearing potential - 40 to 80 years of age - COPD diagnosis - 10 pack-years history or greater of cigarette smoking - Post-bronchodilator FEV1/FVC ratio of 0.70 or less - Post-bronchodilator FEV1 of 25 to 70% of predicted normal Exclusion Criteria: - Asthma - Other significant respiratory disorders besides COPD, including alpha-1 deficiency - Previous lung resection surgery - Chest X-ray or CP scan showing clinically significant abnormalities not due to COPD - Use of oral steroids or antibiotics for a COPD exacerbation within 6 weeks of screening - Hospitalization for COPD or pneumonia within 3 months of screening - Any significant disease that would put subject at risk through study participation - BMI greater than 35 - Pacemaker - Significantly abnormal ECG or clinical lab finding (including Hepatitis B or C) - Cancer - Allergy or hypersensitivity to anticholinergics or inhaler excipients - Diseases that would contraindicate the use of anticholinergics - Use of oral corticosteroids within 6 weeks of screening - Use of long-acting beta-agonists within 48 hours of screening - Use of tiotropium within 14 days of screening - Use of theophyllines or anti-leukotrienes within 48 hours of screening - Use of short-acting bronchodilators within 4 to 6 hours of screening - Use of investigational medicines within 30 days of screening - Use of high dose inhaled corticosteroids - Use of long-term oxygen therapy, CPAP or NIPPV - Participation in acute phase of pulmonary rehabilitation program - History of alcohol or drug abuse within 2 years prior to screening - History of psychiatric disease limiting validity of consent - Affiliation with the investigative site - Previous use of GSK573719
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Data Source: ClinicalTrials.gov
Date Processed: July 12, 2010
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