Trial Information

A 24 week study for patients who suffer from Chronic Obstructive Pulmonary Disease (COPD) due to current or prior history of smoking. Study Medication, Medical Care, Compensation may be provided to patients who qualify.

This study is to evaluate the effect of (GW685698)/Vilanterol (GW642444) inhalation powder delivered once daily via Novel Dry Powder Inhaler for Arterial Stiffness (hardening of the arteries) compared with placebo and Vilanterol in patients who suffer from chronic obstructive pulmonary disease (COPD)

Patient Inclusion Criteria:

Informed consent: Subjects must give their signed and dated written informed consent to participate.
Age: greater than or equal to 40 years of age at Screening (Visit 1)
COPD diagnosis: Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society (ATS) / European Respiratory Society (ERS).
Subjects with a current or prior history of greater than or equal to 10 pack-years of cigarette smoking at Screening (Visit 1).
Subjects with a measured post-albuterol/salbutamol FEV1 less than 70% of predicted at Screening (Visit 1).
Subjects with a measured post-albuterol/salbutamol FEV1/FVC ratio of less than or equal to 0.70 at Screening (Visit 1).
Baseline aPWV: subjects with a measured aPWV greater than 12.0 m/s at Screening (Visit 1).

Patient Exclusion Criteria:

Body Mass Index of less than or equal to 35
Lung Resection within 12 months prior to screen or having had a lung transplantation
Current or severe heart failure
Oxygen use more than 12 hrs/daily
Lower Respiratory Tract Infection that required antibiotic use within 6 months prior to V1
Complete right or left bundle branch block

Jill Keough
Peninsula Research
305 Clyde Morris Blvd, Suite 250.
Ormond Beach, FL 32174
Phone: 386-677-0525
Email: jill@pri-fl.com

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Research Center Information: Peninsula Research

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