Evaluate the Efficacy and Safety of GSK573719 Delivered Via a Novel Dry Powder Inhaler in Subjects With COPD

• Status: Completed
• Trial end date: 2012-02-13
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess if 12 weeks' treatment with GSK573719 Inhalation Powder is safe and effective compared with placebo or no active drug intake, when administered once-daily in subjects with Chronic Obstructive Pulmonary Disease (COPD).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

Inclusion Criteria:

• Diagnosis of COPD

• 10 pack-year or greater history of cigarette smoking

• Post-bronchodilator FEV1/FVC of <0.7

• Predicted FEV1 of 70% of normal or less

• Modified Medical Research Council (mMRC) dyspnea score of 2 or greater

Exclusion Criteria:

• Women who are pregnant, lactating, or planning to become pregnant

• Respiratory disorders other than COPD, including a current diagnosis of asthma

• Clinically significant non-respiratory diseases or abnormalities that are not adequately controlled

• Significant allergy or hypersensitivity to anticholinergics, beta2-agonists, or the excipients of magnesium stereate or lactose used in the inhaler delivery device

• Hospitalization for COPD or pneumonia within 12 weeks prior to screening

• Lung volume reduction surgery within 12 weeks prior to screening

• Abnormal and clinically significant ECG findings at screening

• Clinically significant laboratory findings at screening

• Use of systemic corticosteroids, antibiotics for respiratory tract infections, high dose inhaled steroids (>1000mcg fluticasone propionate or equivalent), PDE4 inhibitors, tiotropium, oral beta2-agoinists, short- and long-acting inhaled beta2-agonists, inhaled sodium cromoglycate or nedocromil sodium, or investigational medicines for defined time periods prior to the screening visit

• Use of long-term oxygen therapy (12 hours or greater per day)

• Regular use of nebulized treatment with short-acting bronchodilators

• Participation in the acute phase of a pulmonary rehabilitation program

• A know or suspected history of alcohol or drug abuse

• Affiliation with the investigational site

• Previous use of GSK573719 or the combination of GSK573719/GW642444