A 24-week Arterial Stiffness Study With Fluticasone Furoate/Vilanterol in COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: Fluticasone Furoate/Vilanterol; Vilanterol; Placebo
Intervention description: Inhaled corticosteroid/long acting beta-agonist; Inhaled long acting beta-agonist; Placebo
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 446.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

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