Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Combination of GSK573719 and GW642444 in Subjects With COPD

• Status: Completed
• Trial end date: 2010-04-20
• Target enrollment: 0
• Participant gender: All

Summary

The study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of the combination of inhaled GSK573719 and GW64244 compared to 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 or more 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 80% or less of predicted normal

Exclusion Criteria:

• Current diagnosis of asthma

• Other significant respiratory disorders besides COPD, including alpha-1 deficiency

• Previous lung resection surgery

• Significant abnormalities in chest x-ray presentation

• Use of oral steroids, antibiotics or hospitalization for a COPD exacerbation within 3 motnhs prior screening

• Any significant disease that would put subject at risk through study participation

• BMI greater than 35

• Pacemaker

• Significantly abnormal ECG, Holter, or clinical lab finding (including Hepatitis B or C)

• Cancer

• Allergy or hypersensitivity to anticholinergics or inhaler excipients

• Diseases that would contra-indicate 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 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

• Previous use of GSK573719 or GW642444