Clinical trial NCT01336608: A 24-week Arterial Stiffness Study With Fluticasone Furoate/Vilanterol in COPD
Official title: 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-04-18
Enrollment: 446
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 24-week Treatment Period (Day 168)
timeFrame: BL to Day 168
Secondary outcomes:
measure: Change From BL in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 168
timeFrame: BL to Day 168
measure: Mean Number of Occasions Rescue Medication [Albuterol (Salbutamol)] Used During a 24-hour Period Averaged Over the Entire 24-week Treatment Period
timeFrame: BL (Week -1), Week 1 to Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Newport Beach
country: United States
facility: GSK Investigational Site
state: California
city: Torrance
country: United States
facility: GSK Investigational Site
state: California
city: DeLand
country: United States
facility: GSK Investigational Site
state: Florida
city: Gainesville
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Ormond Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Winter Park
country: United States
facility: GSK Investigational Site
state: Florida
city: Duluth
country: United States
facility: GSK Investigational Site
state: Georgia
city: Coeur d'Alene
country: United States
facility: GSK Investigational Site
state: Idaho
city: Avon
country: United States
facility: GSK Investigational Site
state: Indiana
city: Lafayette
country: United States
facility: GSK Investigational Site
state: Indiana
city: Muncie
country: United States
facility: GSK Investigational Site
state: Indiana
city: Topeka
country: United States
facility: GSK Investigational Site
state: Kansas
city: Traverse City
country: United States
facility: GSK Investigational Site
state: Michigan
city: Saint Charles
country: United States
facility: GSK Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Shelby
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: GSK Investigational Site
state: Oregon
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Easley
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Fort Mill
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Gaffney
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Rock Hill
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Seneca
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Union
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Johnson City
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Edinburg
country: United States
facility: GSK Investigational Site
state: Texas
city: Abingdon
country: United States
facility: GSK Investigational Site
state: Virginia
city: Elsterwerda
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Magdeburg
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Geesthacht
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Luebeck
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Ansan
country: Korea, Republic of
facility: GSK Investigational Site
city: Gwangju
country: Korea, Republic of
facility: GSK Investigational Site
city: Ilsanseo-gu, Goyang-si, Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Pusan
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Elverum
country: Norway
facility: GSK Investigational Site
city: Kløfta
country: Norway
facility: GSK Investigational Site
city: Moss
country: Norway
facility: GSK Investigational Site
city: Stavanger
country: Norway
facility: GSK Investigational Site
city: Dagupan City
country: Philippines
facility: GSK Investigational Site
city: Jaro, Iloilo City
country: Philippines
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Marilao, Bulacan
country: Philippines
facility: GSK Investigational Site
city: Pasig City
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Chiangmai
country: Thailand
facility: GSK Investigational Site
city: Khon Kaen
country: Thailand
facility: GSK Investigational Site
city: Muang
country: Thailand
facility: GSK Investigational Site
city: Muang
country: Thailand
facility: GSK Investigational Site
city: Nan
country: Thailand
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: