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
Saint Charles, Missouri 63301
1702
mi
from 98109
Saint Charles, MO
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Abingdon, Virginia 24210
2171
mi
from 98109
Abingdon, VA
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Avon, Indiana 46123
1857
mi
from 98109
Avon, IN
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Birmingham, Alabama 35249
2072
mi
from 98109
Birmingham, AL
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Charlotte, North Carolina 28203
2281
mi
from 98109
Charlotte, NC
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Coeur d'Alene, Idaho 83814
258
mi
from 98109
Coeur d'Alene, ID
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Columbus, Ohio 43219
2009
mi
from 98109
Columbus, OH
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DeLand, Florida 32720
2527
mi
from 98109
DeLand, FL
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Duluth, Georgia 30096
2179
mi
from 98109
Duluth, GA
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Easley, South Carolina 29640
2216
mi
from 98109
Easley, SC
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Easley, South Carolina 29640
2216
mi
from 98109
Easley, SC
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Edinburg, Texas 78539
1972
mi
from 98109
Edinburg, TX
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Elsterwerda, Brandenburg 04910
5108
mi
from 98109
Elsterwerda,
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Fort Mill, South Carolina 29707
2291
mi
from 98109
Fort Mill, SC
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Gaffney, South Carolina 29340
2250
mi
from 98109
Gaffney, SC
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Gainesville, Florida 32610
2453
mi
from 98109
Gainesville, FL
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Greenville, South Carolina 29615
2226
mi
from 98109
Greenville, SC
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Johnson City, Tennessee 37601
2169
mi
from 98109
Johnson City, TN
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Lafayette, Indiana 47904
1812
mi
from 98109
Lafayette, IN
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Medford, Oregon 97504
367
mi
from 98109
Medford, OR
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Muncie, Indiana 47304
1890
mi
from 98109
Muncie, IN
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Newport Beach, California 92663
995
mi
from 98109
Newport Beach, CA
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Oklahoma City, Oklahoma 73112
1519
mi
from 98109
Oklahoma City, OK
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Orlando, Florida 32806
2549
mi
from 98109
Orlando, FL
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Ormond Beach, Florida 32174
2527
mi
from 98109
Ormond Beach, FL
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Phoenix, Arizona 85012
1112
mi
from 98109
Phoenix, AZ
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Pittsburgh, Pennsylvania 15213
2134
mi
from 98109
Pittsburgh, PA
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Rock Hill, South Carolina 29732
2285
mi
from 98109
Rock Hill, SC
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Saint Louis, Missouri 63110
1718
mi
from 98109
Saint Louis, MO
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Seneca, South Carolina 29678
2205
mi
from 98109
Seneca, SC
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Shelby, North Carolina 28152
2246
mi
from 98109
Shelby, NC
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Spartanburg, South Carolina 29303
2240
mi
from 98109
Spartanburg, SC
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Topeka, Kansas 66604
1453
mi
from 98109
Topeka, KS
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Torrance, California 90502
976
mi
from 98109
Torrance, CA
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Traverse City, Michigan 49684
1750
mi
from 98109
Traverse City, MI
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Union, South Carolina 29379
2269
mi
from 98109
Union, SC
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Winston-Salem, North Carolina 27103
2272
mi
from 98109
Winston-Salem, NC
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Winter Park, Florida 32789
2545
mi
from 98109
Winter Park, FL
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