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

Completed · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT01336608

Run by

GlaxoSmithKline

People needed

446

Starts

2011-03-04

Expected to finish

2014-11-04

Last updated by the study team

2017-11-08

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• COPD diagnosis defined by ATS/ERS
• Former or current smoker
• A measured aortic pulse wave velocity = or > 11.0 m/s at Screening

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Newport Beach, California, United States
• GSK Investigational Site — Torrance, California, United States
• GSK Investigational Site — DeLand, Florida, United States
• GSK Investigational Site — Gainesville, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Ormond Beach, Florida, United States
• GSK Investigational Site — Winter Park, Florida, United States
• GSK Investigational Site — Duluth, Georgia, United States
• GSK Investigational Site — Coeur d'Alene, Idaho, United States
• GSK Investigational Site — Avon, Indiana, United States
• GSK Investigational Site — Lafayette, Indiana, United States
• GSK Investigational Site — Muncie, Indiana, United States
• GSK Investigational Site — Topeka, Kansas, United States
• GSK Investigational Site — Traverse City, Michigan, United States
• GSK Investigational Site — Saint Charles, Missouri, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Charlotte, North Carolina, United States
• GSK Investigational Site — Shelby, North Carolina, United States
• GSK Investigational Site — Winston-Salem, North Carolina, United States
• GSK Investigational Site — Columbus, Ohio, United States
• GSK Investigational Site — Oklahoma City, Oklahoma, United States
• GSK Investigational Site — Medford, Oregon, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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