Health Condition 1: null- Moderate Chronic Obstructive Pulmonary Disease and a history of or at increased risk for cardiovascular disease
Conditions
Interventions
Intervention1: Fluticasone Furoate Inhalation powder 100mcg and Vilanterol Inhalation powder 25mcg: Fluticasone Furoate 100mcg and Vilanterol 25mcg Inhalation Powder administered once daily dose via t
Sponsors
GlaxoSmithKline
PAREXEL International Clinical Research Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Type of subject: outpatient. 2.Informed consent: Subjects must give their signed and dated written informed consent to participate. 3.Gender: Male or female. Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception. 4.Age: > or equal to 40 years and 5.Tobacco use: Subjects with a current or prior history of > or equal to 10 pack-years of cigarette smoking at screening (Visit 1). Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1 6.Airflow Obstruction: Subjects with a measured post-albuterol/salbutamol forced expiratory volume in 1 second (FEV1)/(forced vital capacity)FVC ratio of Subjects with a measured post-albuterol/salbutamol FEV1 > or equal to 50 and Post-bronchodilator spirometry will be performed approximately 15 minutes after the subject has self-administered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via a metered dose inhaler (MDI )with a valved-holding chamber. The FEV1/FVC ratio and FEV1 percent predicted values will be calculated. 7.Symptoms of COPD: Subjects must score 2 or higher on the modified Medical Research Council Dyspnea scale (Visit 1) 8.Cardiovascular disease: For patients > or equal to 40 years of age: any one of the following: Established (i.e. by clinical signs or imaging studies) coronary artery disease (CAD) Established (i.e. by clinical signs or imaging studies) peripheral vascular disease (PVD) Previous stroke Previous MI Diabetes mellitus with target organ disease OR For patients > or equal to 60 years of age: any 2 of the following: Being treated for hypercholesterolemia Being treated for hypertension Being treated for diabetes mellitus Being treated for peripheral vascular disease
Exclusion criteria
Exclusion criteria: 1.Pregnancy: Women who are pregnant or lactating. 2.Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they also have a current diagnosis of COPD) 3.alpha 1-antitrypsin deficiency: Subjects with known alpha-1 antitrypsin deficiency as the underlying cause of COPD. 4.Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases. 5.Lung resection or transplantation: Subjects with lung volume reduction surgery within the 12 months prior to Screening or having had a lung transplant. 6.A moderate/severe COPD exacerbation that has not resolved at least 14 days prior to Visit 1 and at least 30 days following the last dose of oral corticosteroids (if applicable). 7.Current severe heart failure (New York Heart Association class IV). Subjects will also be excluded if they have a known ejection fraction of 8.Other diseases/abnormalities: Any life-threatening condition with life expectancy 9.End stage chronic renal disease: Subjects will be excluded if on renal replacement therapy (hemodialysis or peritoneal). 10.Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g. beta-agonists, corticosteroid) or components of the inhalation powder (e.g. lactose, magnesium stearate). In addition, patients with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates the subjects participation will also be excluded. 11.Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years. 12.Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e. 13.Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study or the potential compliance to study procedures. 14.Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study. 15.Additional medication: Use of the following medications within the following time intervals prior to Visit 1 or during the study (unless otherwise specified): Medication No use within the following time intervals prior to Screening or thereafter at any time during the study (unless otherwise specified) Inhaled Long acting beta-agonists (LABA) 48 hours ICS/LABA combination products 48 hours Inhaled corticosteroids 48 hours Tiotropium 1 week Systemic, Oral, parenteral, intra-articular corticosteroids 30 days (oral and systemic corticosteroids may be used to treat COPD exacerbations during the study) Cytochrome P450 3A4 strong inhibitors including but not limited to antiretrovirals (protease inhibitors) (e.g.Indinavir, Nelfinavir, Ritonavir, Saqui
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival in subjects with moderate COPD (â?¥50% and â?¤70 % predicted Forced Expiratory Volume in One Second - FEV1) with a history of, or at increased risk for cardiovascular diseaseTimepoint: Time to death from any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| A cardiovascular composite endpoint comprised of on-treatment Cardiovascular death, myocardial infarction, stroke, unstable angina and TIA on the the effect of Fluticasone Furoate/Vilanterol compared with placeboTimepoint: Time to Cardiovascular event;The rate of decline in Forced Expiratory Volume in One Second (FEV1) as the effect of Fluticasone Furoate and Vilanterol compared with placeboTimepoint: Rate of decline in Forced Expiratory Volume in One Second (FEV1) | — |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Democratic People's Republic of Korea, Denmark, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Pakistan, Peru, Philippines, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Taiwan, Thailand, The former Yugoslav Republic of Macedonia, Turkey, Ukraine, United Kingdom, United States of America, Viet Nam
Contacts
Public ContactDr Annappa Kamath
PAREXEL International Clinical Research Private Limited
Outcome results
None listed