Phase 3 N=559 Randomized Double-blind Treatment

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

Pulmonary Disease, Chronic Obstructive

Bottom Line

View on ClinicalTrials.gov: NCT01336608 ↗

Enrolled (actual)

559

Serious AEs

5.9%

Results posted

Jul 2015

Primary outcome: Primary: Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 24-week Treatment Period (Day 168) — -1.97; -1.95; -1.75 meters per second (m/sec) — p=0.969

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Fluticasone Furoate/Vilanterol (Drug); Vilanterol (Drug); Placebo (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Nov 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 24-week Treatment Period (Day 168)	-1.97; -1.95; -1.75	0.969
SECONDARY Change From BL in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 168	-0.049; 0.033; 0.106	0.007 sig
SECONDARY Mean Number of Occasions Rescue Medication [Albuterol (Salbutamol)] Used During a 24-hour Period Averaged Over the Entire 24-week Treatment Period	1.97; 1.50; 1.47	<0.001 sig

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01336608). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.