a 24-week arterial stiffness study with fluticasone furoate/vilanterol in copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of the study is to investigate the effect of fluticasone furoate/vilanterol inhalation powder on arterial stiffness compared with placebo and vilanterol over a 24-week treatment period in subjects with copd and aortic pulse wave velocity of 11.0 m/s or above.


Eligibility criteria:
inclusion criteria: * copd diagnosis defined by ats/ers * former or current smoker * a measured aortic pulse wave velocity = or \> 11.0 m/s at screening exclusion criteria: * pregnancy * a current diagnosis of asthma * alpha1-antitrypsin deficiency as the underlying cause of copd * subjects with other and active respiratory disorders * a cardiovascular event occurred in the 6 months prior to visit 1 * current severe heart failure (new york heart association class iv) and have a known ejection fraction of \< 30 % * clinical significant and uncontrolled hypertension * abnormal and clinical significant 12-lead ecg findings at visit 1 * have lung volume reduction or lung transplantation within 12 months prior to visit 1 * poorly controlled copd: acute worsening of copd that is managed by subject with antibiotics or corticosteroids, or requires treatment prescribed by a physician in the 6 weeks prior to visit 1; or subject needs to be hospitalised due to poorly controlled copd within 12 weeks prior to visit 1 * lower respiratory tract infection that required use of antibiotics within 6 weeks prior to visit 1 * participate in the acute phase of a pulmonary rehabilitation within 4 weeks prior to visit 1 or who will enter the acute phase of pulmonary rehabilitation during the study. * other diseases or abnormalities in the opinion of the investigator would put safety of the subject at risk through participation; or would affect the safety or efficacy analysis if the disease/condition exacerbated during the study. * subjects with carcinoma has not been in complete remission for at least 5 years. carcinoma in site of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis. * subjects with a history of hypersensitivity to any of the study medications or components of the inhalation powder. * subjects with a known or suspected history of alcohol or drug abuse within the last 2 years prior to screening * subjects are medically unable to withhold albuterol or ipratropium for 4 hours prior to spirometry testing at each study visit * subjects are medically unable to stop the 'excluded medications' listed in the protocol * subjects started, discontinued certain medications listed in the protocol or have not been on a stable dose in the past three months prior to screening, or are not anticipated to remain on a stable dose during the study treatment period. * long term oxygen therapy requiring \>12 hour per day or a flow rate \> 2 l/min * a body mass index = or \>35 kg/m2 * fasting lipid level ldl\>3.3 mmol/l, total cholesterol \>5.2 mmol/l, and triglycerides \> 2.24mmol/l * non-compliance * questionable validity of consent * prior use of study medication or other investigational drugs. * affiliation with investigator site