28-day Repeat Dose Study of GSK573719

• Status: Completed
• Trial end date: 2010-07-04
• Target enrollment: 0
• Participant gender: All

Summary

The study will evaluate the efficacy, safety, and pharmacokinetics of GSK573719 compared with placebo in subjects with COPD

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

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