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
sites
Fort Mill, South Carolina 29707
2104
mi
from 91732
Fort Mill, SC
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Abingdon, Virginia 24210
2025
mi
from 91732
Abingdon, VA
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Avon, Indiana 46123
1780
mi
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Avon, IN
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Birmingham, Alabama 35249
1777
mi
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Birmingham, AL
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Charlotte, North Carolina 28203
2100
mi
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Charlotte, NC
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Coeur d'Alene, Idaho 83814
942
mi
from 91732
Coeur d'Alene, ID
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Columbus, Ohio 43219
1965
mi
from 91732
Columbus, OH
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DeLand, Florida 32720
2177
mi
from 91732
DeLand, FL
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Duluth, Georgia 30096
1930
mi
from 91732
Duluth, GA
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Easley, South Carolina 29640
2007
mi
from 91732
Easley, SC
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Easley, South Carolina 29640
2007
mi
from 91732
Easley, SC
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Edinburg, Texas 78539
1298
mi
from 91732
Edinburg, TX
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Elsterwerda, Brandenburg 04910
5837
mi
from 91732
Elsterwerda,
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Gaffney, South Carolina 29340
2058
mi
from 91732
Gaffney, SC
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Gainesville, Florida 32610
2105
mi
from 91732
Gainesville, FL
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Greenville, South Carolina 29615
2022
mi
from 91732
Greenville, SC
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Johnson City, Tennessee 37601
2009
mi
from 91732
Johnson City, TN
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Lafayette, Indiana 47904
1757
mi
from 91732
Lafayette, IN
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Medford, Oregon 97504
628
mi
from 91732
Medford, OR
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Muncie, Indiana 47304
1835
mi
from 91732
Muncie, IN
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Newport Beach, California 92663
31
mi
from 91732
Newport Beach, CA
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Oklahoma City, Oklahoma 73112
1161
mi
from 91732
Oklahoma City, OK
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Orlando, Florida 32806
2186
mi
from 91732
Orlando, FL
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Ormond Beach, Florida 32174
2186
mi
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Ormond Beach, FL
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Phoenix, Arizona 85012
343
mi
from 91732
Phoenix, AZ
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Pittsburgh, Pennsylvania 15213
2121
mi
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Pittsburgh, PA
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Rock Hill, South Carolina 29732
2094
mi
from 91732
Rock Hill, SC
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Saint Charles, Missouri 63301
1558
mi
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Saint Charles, MO
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Saint Louis, Missouri 63110
1570
mi
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Saint Louis, MO
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Seneca, South Carolina 29678
1989
mi
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Seneca, SC
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Shelby, North Carolina 28152
2062
mi
from 91732
Shelby, NC
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Spartanburg, South Carolina 29303
2042
mi
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Spartanburg, SC
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Topeka, Kansas 66604
1280
mi
from 91732
Topeka, KS
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Torrance, California 90502
22
mi
from 91732
Torrance, CA
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Traverse City, Michigan 49684
1864
mi
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Traverse City, MI
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Union, South Carolina 29379
2067
mi
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Union, SC
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Winston-Salem, North Carolina 27103
2122
mi
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Winston-Salem, NC
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Winter Park, Florida 32789
2184
mi
from 91732
Winter Park, FL
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