A Clinical Outcomes Study to compare the effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg with placebo on Survival in Subjects with moderate Chronic Obstructive Pulmonary Disease (COPD) and a history of or at increased risk for cardiovascular disease. - SUMMIT

GlaxoSmithKline0 sites16,000 target enrollmentTBD

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: GlaxoSmithKline
Enrollment: 16000
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Investigators

Sponsor

GlaxoSmithKline

Eligibility 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 \< or equal to 80 years of age at Screening (Visit 1\).
•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 \< or equal to 0\.70 at Screening (Visit 1\).
•Subjects with a measured post\-albuterol/salbutamol FEV1 \> or equal to 50 and \< or equal to 70% of predicted normal values calculated using NHANES III reference equations \[Hankinson, 1999; Hankinson, 2010] at Screening (Visit 1\).
•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:

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 \<30% or if they have an implantable cardioverter defibrillator (ICD).
•8\.Other diseases/abnormalities: Any life\-threatening condition with life expectancy \<3 years, other than vascular disease or COPD, that might prevent the subject from completing the study.
•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.