GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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

Key facts

Study ID

NCT00950807

Run by

GlaxoSmithKline

People needed

176

Starts

2009-09-01

Expected to finish

2010-03-15

Last updated by the study team

2017-11-08

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 35 to 70% of predicted normal

You may not qualify if…

• Asthma
• Other significant respiratory disorders besides COPD, including alpha-1 deficiency
• Previous lung resection surgery
• 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, 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 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
• Previous use of GSK573719

Where it is running

• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Upland, California, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Easley, South Carolina, United States
• GSK Investigational Site — Gaffney, South Carolina, United States
• GSK Investigational Site — Greenville, South Carolina, United States
• GSK Investigational Site — Seneca, 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 — Wiesbaden, Hesse, Germany
• GSK Investigational Site — Hanover, Lower Saxony, Germany
• GSK Investigational Site — Mainz, Rhineland-Palatinate, Germany
• GSK Investigational Site — Magdeburg, Saxony-Anhalt, Germany
• GSK Investigational Site — Großhansdorf, Schleswig-Holstein, Germany
• GSK Investigational Site — Berlin, Germany
• GSK Investigational Site — Berlin, Germany
• GSK Investigational Site — Hamburg, Germany

Full record on ClinicalTrials.gov

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