A 12-week study to evaluate the effect of fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) 100/25 mcg Inhalation Powder delivered once daily via a Novel Dry Powder Inhaler (NDPI) on arterial stiffness compared with Tiotropium bromide 18 mcg delivered once daily via a HandiHaler in subjects with Chronic Obstructive Pulmonary Disease (COPD)

GlaxoSmithKline Research & Development Ltd0 sites248 target enrollmentMarch 17, 2011

Conditionssubjects with Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

DrugsSPIRIVA®

Overview

Phase: N/A
Intervention: Not specified
Conditions: subjects with Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: GlaxoSmithKline Research & Development Ltd
Enrollment: 248
Status: Active, Not Recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 17, 2011

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Research & Development Ltd

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 subjects
•A female is eligible to enter and participate in the study if she is of:
•Non\-child bearing potential (i.e., physiologically incapable of becoming pregnant,
•including any female who is post\-menopausal or surgically sterile). Surgically sterile
•females are defined as those with a documented hysterectomy and/or bilateral
•oophorectomy or tubal ligation. Post\-menopausal females are defined as being
•amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g., age

Exclusion Criteria

•1Pregnancy:Women who are pregnant or lactating or are planning on becoming pregnant during the study.
•2Asthma:Subjects with a current diagnosis of asthma. Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD.
•3Other respiratory disorders:The investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease. View protocol for further information.
•4A cardiovascular event:(e.g., Acute Coronary Syndrome, Stroke, Coronary Artery Bypass Surgery, Percutaneous Coronary Intervention) in the 6 months prior to Visit 1\.
•5Lung resection:Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1\) or having had lung transplantation.
•6Poorly controlled COPD:Subjects with poorly controlled COPD, defined as the occurrence of ‘acute worsening of COPD that is managed by subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician in the 6 weeks prior to Visit 1 or ‘subjects who are hospitalized due to poorly controlled COPD within 12 weeks of Visit 1’
•7Lower respiratory tract infection:Subjects with lower respiratory tract
•infection that required the use of antibiotics within 6 weeks prior to Visit 1\.
•8Other diseases/abnormalities:Subjects with historical or current evidence of clinically significant cardiovascular, gastrointestinal, neurological, psychiatric, renal, hepatic, immunological, endocrine view protocol for further nformation.
•9Current severe heart failure (New York Heart Association class IV). Subject will be excluded if they have a known ejection fraction of \<30%.