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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Placebo; Drug: Vilanterol; Drug: Fluticasone Furoate/Vilanterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01336608

113108

Details and patient eligibility

About

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.

Enrollment: 446 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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446 participants in 3 patient groups, including a placebo group

Fluticasone Furoate/Vilanterol

Experimental group

Description:

Inhaled corticosteroid/long acting beta-agonist

Treatment:

Drug: Fluticasone Furoate/Vilanterol

vilanterol

Experimental group

Description:

Inhaled long acting beta-agonist

Treatment:

Drug: Vilanterol

placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo