28-day Repeat Dose Study of GSK573719

Completed · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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

Key facts

Study ID

NCT01030965

Run by

GlaxoSmithKline

People needed

285

Starts

2009-12-15

Expected to finish

2010-07-04

Last updated by the study team

2018-03-09

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 25 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
• 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

Where it is running

• GSK Investigational Site — Madisonville, Kentucky, United States
• GSK Investigational Site — Charlotte, North Carolina, United States
• GSK Investigational Site — Spartanburg, South Carolina, United States
• GSK Investigational Site — Union, South Carolina, United States
• GSK Investigational Site — Tallinn, Estonia
• GSK Investigational Site — Tallinn, Estonia
• GSK Investigational Site — Tallinn, Estonia
• GSK Investigational Site — Tartu, Estonia
• GSK Investigational Site — Wiesbaden, Hesse, Germany
• GSK Investigational Site — Schwerin, Mecklenburg-Vorpommern, Germany
• GSK Investigational Site — Großhansdorf, Schleswig-Holstein, Germany
• GSK Investigational Site — Berlin, Germany
• GSK Investigational Site — Berlin, Germany
• GSK Investigational Site — Berlin, Germany
• GSK Investigational Site — Hamburg, Germany
• GSK Investigational Site — Bialystok, Poland
• GSK Investigational Site — Bialystok, Poland
• GSK Investigational Site — Gidle, Poland
• GSK Investigational Site — Krakow, Poland
• GSK Investigational Site — Lublin, Poland

Full record on ClinicalTrials.gov

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