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).
Overview
- Phase
- Phase 3
- Intervention
- Vilanterol
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- GlaxoSmithKline
- Enrollment
- 446
- Locations
- 1
- Primary Endpoint
- Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 24-week Treatment Period (Day 168)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
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
Arms & Interventions
vilanterol
Inhaled long acting beta-agonist
Intervention: Vilanterol
placebo
Placebo
Intervention: Placebo
Fluticasone Furoate/Vilanterol
Inhaled corticosteroid/long acting beta-agonist
Intervention: Fluticasone Furoate/Vilanterol
Outcomes
Primary Outcomes
Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 24-week Treatment Period (Day 168)
Time Frame: BL to 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.
Secondary Outcomes
- 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)