28-day Repeat Dose Study of GSK573719



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - 80
Updated:4/17/2018
Start Date:December 15, 2009
End Date:July 4, 2010

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A Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of GSK573719 Delivered Once-daily Over 28 Days in Subjects With COPD

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

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to
evaluate 3 doses of GSK573719 administered once-daily over 28 days in subjects with COPD.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Previous use of GSK573719
We found this trial at
5
sites
Tallinn, 13619
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Tallinn,
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Charlotte, North Carolina 28203
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Charlotte, NC
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Madisonville, Kentucky 42431
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Madisonville, KY
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Spartanburg, South Carolina 29303
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Spartanburg, SC
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Union, South Carolina 29379
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Union, SC
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