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

NCT ID: NCT01336608

Last Updated: 2017-11-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

446 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-04

Study Completion Date

2014-11-04

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fluticasone Furoate/Vilanterol

Inhaled corticosteroid/long acting beta-agonist

Group Type EXPERIMENTAL

Fluticasone Furoate/Vilanterol

Intervention Type DRUG

Inhaled corticosteroid/long acting beta-agonist

vilanterol

Inhaled long acting beta-agonist

Group Type EXPERIMENTAL

Vilanterol

Intervention Type DRUG

Inhaled long acting beta-agonist

placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Fluticasone Furoate/Vilanterol

Inhaled corticosteroid/long acting beta-agonist

Intervention Type DRUG

Vilanterol

Inhaled long acting beta-agonist

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

Site Status

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Phoenix, Arizona, United States

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Newport Beach, California, United States

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Torrance, California, United States

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DeLand, Florida, United States

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Gainesville, Florida, United States

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Orlando, Florida, United States

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Ormond Beach, Florida, United States

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Winter Park, Florida, United States

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Duluth, Georgia, United States

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Coeur d'Alene, Idaho, United States

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Avon, Indiana, United States

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Lafayette, Indiana, United States

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Muncie, Indiana, United States

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Topeka, Kansas, United States

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Traverse City, Michigan, United States

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Saint Charles, Missouri, United States

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St Louis, Missouri, United States

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Charlotte, North Carolina, United States

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Shelby, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Easley, South Carolina, United States

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Fort Mill, South Carolina, United States

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Gaffney, South Carolina, United States

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Greenville, South Carolina, United States

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Rock Hill, South Carolina, United States

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Seneca, South Carolina, United States

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Spartanburg, South Carolina, United States

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Union, South Carolina, United States

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Johnson City, Tennessee, United States

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Edinburg, Texas, United States

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Abingdon, Virginia, United States

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Elsterwerda, Brandenburg, Germany

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Frankfurt am Main, Hesse, Germany

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Dresden, Saxony, Germany

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Leipzg, Saxony, Germany

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Magdeburg, Saxony-Anhalt, Germany

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Geesthacht, Schleswig-Holstein, Germany

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Lübeck, Schleswig-Holstein, Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Hamburg, , Germany

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Elverum, , Norway

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Kløfta, , Norway

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Moss, , Norway

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Stavanger, , Norway

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Dagupan, , Philippines

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Jaro, Iloilo City, , Philippines

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Manila, , Philippines

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Marilao, Bulacan, , Philippines

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Pasig, , Philippines

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Quezon City, , Philippines

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Ansan, , South Korea

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Gwangju, , South Korea

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Ilsanseo-gu, Goyang-si, Gyeonggi-do, , South Korea

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Pusan, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Bangkok, , Thailand

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Bangkok, , Thailand

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Chiang Mai, , Thailand

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Khon Kaen, , Thailand

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Muang, , Thailand

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Muang, , Thailand

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GSK Investigational Site

Nan, , Thailand

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Countries

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United States Germany Norway Philippines South Korea Thailand

Study Documents

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Document Type: Individual Participant Data Set

View Document

Document Type: Informed Consent Form

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Document Type: Dataset Specification

View Document

Document Type: Clinical Study Report

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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113108

Identifier Type: -

Identifier Source: org_study_id