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

Completed · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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).

Key facts

Study ID

NCT01387230

Run by

GlaxoSmithKline

People needed

206

Starts

2011-07-01

Expected to finish

2012-02-13

Last updated by the study team

2017-11-09

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Sunset, Louisiana, United States
• GSK Investigational Site — Easley, South Carolina, United States
• GSK Investigational Site — Spartanburg, South Carolina, United States
• GSK Investigational Site — Union, South Carolina, United States
• GSK Investigational Site — Frankfurt am Main, Hesse, Germany
• GSK Investigational Site — Gelnhausen, Hesse, Germany
• GSK Investigational Site — Kassel, Hesse, Germany
• GSK Investigational Site — Hanover, Lower Saxony, Germany
• GSK Investigational Site — Weyhe-Leeste, Lower Saxony, Germany
• GSK Investigational Site — Cologne, North Rhine-Westphalia, Germany
• GSK Investigational Site — Goch, North Rhine-Westphalia, Germany
• GSK Investigational Site — Solingen, North Rhine-Westphalia, Germany
• GSK Investigational Site — Koblenz, Rhineland-Palatinate, Germany
• GSK Investigational Site — Leipzg, Saxony, Germany
• GSK Investigational Site — Leipzig, Saxony, Germany
• GSK Investigational Site — Teuchern, Saxony-Anhalt, Germany
• GSK Investigational Site — Lübeck, Schleswig-Holstein, Germany
• GSK Investigational Site — Berlin, Germany
• GSK Investigational Site — Berlin, Germany
• GSK Investigational Site — Berlin, Germany
• GSK Investigational Site — Berlin, Germany
• GSK Investigational Site — Berlin, Germany
• GSK Investigational Site — Ibaraki, Japan
• GSK Investigational Site — Kagawa, Japan
• GSK Investigational Site — Kyoto, Japan

Full record on ClinicalTrials.gov

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