A 24-week Arterial Stiffness Study With Fluticasone Furoate/Vilanterol in COPD

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