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

NCT01336608 | Completed Phase 3 Results

• 1 other identifier: 113108
• Study Type: interventional
• Target: 446
• Locations: 6 countries
• Sites: 72

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 24-week Treatment Period (Day 168)

  PWV is defined as the speed of travel of the pressure pulse along an arterial segment and can be obtained for any arterial segment accessible to palpation. aPWV is measured with tonometers positioned transcutaneously at the base of the common carotid artery and over the femoral artery. PWV increases with arterial stiffness and is defined by the Moens-Korteweg equation: PWV=square root of (Eh/2ρR), where E is Young's modulus of the arterial wall, h is the wall thickness, R is the arterial radius at the end of diastole, and ρ is the blood density. Change from BL was calculated as the Day 168 value minus the BL value. The analysis was performed using a repeated measures model with covariates of treatment, visit, age, gender, smoking history, history of exacerbation strata, geographical region, BL aPWV and interaction terms of BL by visit and treatment by visit.

  BL to Day 168

Secondary Outcomes (2)

• Change From BL in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 168

  BL to Day 168

• Mean Number of Occasions Rescue Medication [Albuterol (Salbutamol)] Used During a 24-hour Period Averaged Over the Entire 24-week Treatment Period

  BL (Week -1), Week 1 to Week 24

Study Arms (3)

Fluticasone Furoate/Vilanterol

EXPERIMENTAL

Inhaled corticosteroid/long acting beta-agonist

Drug: Fluticasone Furoate/Vilanterol

vilanterol

EXPERIMENTAL

Inhaled long acting beta-agonist

Drug: Vilanterol

placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Fluticasone Furoate/Vilanterol DRUG

Inhaled corticosteroid/long acting beta-agonist

Fluticasone Furoate/Vilanterol

Vilanterol DRUG

Inhaled long acting beta-agonist

vilanterol

Placebo DRUG

Placebo

placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (72)

GSK Investigational Site

Birmingham, Alabama, 35294, United States

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Phoenix, Arizona, 85006, United States

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Newport Beach, California, 92663, United States

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Torrance, California, 90505, United States

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DeLand, Florida, 32720, United States

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Gainesville, Florida, 32608, United States

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Orlando, Florida, 32825, United States

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Ormond Beach, Florida, 32174, United States

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Winter Park, Florida, 32789, United States

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Duluth, Georgia, 30096, United States

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Coeur d'Alene, Idaho, 83814, United States

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Avon, Indiana, 46123, United States

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Lafayette, Indiana, 47904, United States

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Muncie, Indiana, 47304-5547, United States

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Topeka, Kansas, 66606, United States

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Traverse City, Michigan, 49684, United States

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Saint Charles, Missouri, 63301, United States

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St Louis, Missouri, 63141, United States

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Charlotte, North Carolina, 28207, United States

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Shelby, North Carolina, 28152, United States

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Winston-Salem, North Carolina, 27103, United States

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Columbus, Ohio, 43215, United States

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Oklahoma City, Oklahoma, 73103, United States

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Medford, Oregon, 97504, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Easley, South Carolina, 29640, United States

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Fort Mill, South Carolina, 29707, United States

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Gaffney, South Carolina, 29340, United States

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Greenville, South Carolina, 29615, United States

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Rock Hill, South Carolina, 29732, United States

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Seneca, South Carolina, 29678, United States

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Spartanburg, South Carolina, 29303, United States

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Union, South Carolina, 29379, United States

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Johnson City, Tennessee, 37601, United States

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Edinburg, Texas, 78539, United States

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Abingdon, Virginia, 24210, United States

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Elsterwerda, Brandenburg, 04910, Germany

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Frankfurt am Main, Hesse, 60596, Germany

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Dresden, Saxony, 01069, Germany

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Leipzg, Saxony, 04109, Germany

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Magdeburg, Saxony-Anhalt, 39112, Germany

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Geesthacht, Schleswig-Holstein, 21502, Germany

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Lübeck, Schleswig-Holstein, 23552, Germany

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Berlin, 10717, Germany

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Berlin, 10787, Germany

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Berlin, 10789, Germany

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Hamburg, 20253, Germany

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Elverum, 2408, Norway

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Kløfta, 2040, Norway

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Moss, 1501, Norway

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Stavanger, 4005, Norway

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Dagupan, 2400, Philippines

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Jaro, Iloilo City, 5000, Philippines

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Manila, 1000, Philippines

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Marilao, Bulacan, 3019, Philippines

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Pasig, 1600, Philippines

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Quezon City, 1100, Philippines

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Ansan, 425-707, South Korea

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Gwangju, 501-757, South Korea

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Ilsanseo-gu, Goyang-si, Gyeonggi-do, 411706, South Korea

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Pusan, 614-735, South Korea

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Seoul, 134-090, South Korea

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Seoul, 134060, South Korea

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Seoul, 137-701, South Korea

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Seoul, 152-703, South Korea

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Bangkok, 10400, Thailand

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Bangkok, 10700, Thailand

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Chiang Mai, 50200, Thailand

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GSK Investigational Site

Khon Kaen, 40002, Thailand

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GSK Investigational Site

Muang, 11000, Thailand

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GSK Investigational Site

Muang, 65000, Thailand

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GSK Investigational Site

Nan, 55000, Thailand

Location

Related Links

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

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

fluticasone furoate; vilanterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2011
• First Posted: April 18, 2011
• Study Start: March 4, 2011
• Primary Completion: November 4, 2014
• Study Completion: November 4, 2014
• Last Updated: November 8, 2017
• Results First Posted: July 10, 2015

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

DE (11); KR (8); TH (7); NO (4); PH (6); US (36)