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

• Status: Completed
• Trial end date: 2014-11-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluticasone; Xhance

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