28-day Repeat Dose Study of GSK573719
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Intervention: GSK573719 125mcg; GSK573719 250mcg; GSK573719 500mcg; Placebo
Intervention description: 125mcg once-daily; 250mcg once-daily; 500mcg once-daily; once-daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 285.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic Bronchitis; Anticholinergic; Emphysema; Long-acting muscarinic antagonist; COPD

Summary:

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

Eligibility 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