28-day Repeat Dose Study of GSK573719 - NCT01030965-29303B (Clinical Trial 463291)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy463291.aspx
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| City: |
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Spartanburg |
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State:
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SC |
| Zip Code: |
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29303 |
| Conditions: |
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Chronic Bronchitis - Emphysema - Pulmonary Disease, Chronic Obstructive |
| Purpose: |
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The study will evaluate the efficacy, safety, and pharmacokinetics of GSK573719 compared
with placebo in subjects with COPD
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| Study summary: |
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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. |
| Criteria: |
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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 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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