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



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:11/10/2017
Start Date:March 4, 2011
End Date:November 4, 2014

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A 24-week Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder Delivered Once-daily Via a Novel Dry Powder Inhaler on Arterial Stiffness Compared With Placebo and Vilanterol in Subjects With Chronic Obstructive Pulmonary Disease (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.


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
We found this trial at
38
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Gainesville, Florida 32610
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Abingdon, Virginia 24210
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Avon, Indiana 46123
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Birmingham, Alabama 35249
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Charlotte, North Carolina 28203
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Coeur d'Alene, Idaho 83814
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Columbus, Ohio 43219
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DeLand, Florida 32720
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Duluth, Georgia 30096
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Easley, South Carolina 29640
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Easley, South Carolina 29640
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Edinburg, Texas 78539
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Elsterwerda, Brandenburg 04910
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Fort Mill, South Carolina 29707
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Gaffney, South Carolina 29340
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Greenville, South Carolina 29615
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Johnson City, Tennessee 37601
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Lafayette, Indiana 47904
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Medford, Oregon 97504
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Muncie, Indiana 47304
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Newport Beach, California 92663
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Oklahoma City, Oklahoma 73112
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Orlando, Florida 32806
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Ormond Beach, Florida 32174
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Phoenix, Arizona 85012
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Pittsburgh, Pennsylvania 15213
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Rock Hill, South Carolina 29732
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Saint Charles, Missouri 63301
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Saint Louis, Missouri 63110
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Seneca, South Carolina 29678
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Shelby, North Carolina 28152
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Spartanburg, South Carolina 29303
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Topeka, Kansas 66604
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Torrance, California 90502
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Traverse City, Michigan 49684
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Union, South Carolina 29379
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Winston-Salem, North Carolina 27103
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Winter Park, Florida 32789
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