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(COPD).","org_study_id":"113108","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Completed - Interventional","oversight_info":{"exported_from_us":"","fda_regulated_device":"","fda_regulated_drug":"","ped_postmarket_surv":"","has_dmc":null,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"Phase 3","primary_compl_date":"11/04/2014 00:00:00","primary_outcomes":[{"outcome_description":"PWV is defined as the speed of travel of the pressure pulse along an arterial segment and can be obtained for any arterial segment accessible to palpation. aPWV is measured with tonometers positioned transcutaneously at the base of the common carotid artery and over the femoral artery. PWV increases with arterial stiffness and is defined by the Moens-Korteweg equation: PWV=square root of (Eh/2ρR), where E is Young’s modulus of the arterial wall, h is the wall thickness, R is the arterial radius at the end of diastole, and ρ is the blood density. Change from BL was calculated as the Day 168 value minus the BL value. The analysis was performed using a repeated measures model with covariates of treatment, visit, age, gender, smoking history, history of exacerbation strata, geographical region, BL aPWV and interaction terms of BL by visit and treatment by visit.","outcome_measure":"Mean change from Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the end of the 24-week Treatment Period (Day 168)","outcome_time_frame":"BL to Day 168","outcome_safety_issue":null}],"product_name":"fluticasone furoate;fluticasone furoate/vilanterol;vilanterol","product_name_OneLinkTx":"","secondary_ids":[{"id":"2010-023091-10","id_type":"EudraCT Number","id_domain":""}],"secondary_outcomes":[{"outcome_description":"Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry at Screening, Days 1, 28, 84, 126, and 168. BL FEV1 was defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 was defined as the mean of the FEV1 values obtained 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was preformed using a repeated measures model with covariates of visit, treatment, history of exacerbation strata, geographical region, BL FEV1 and interaction terms of BL by visit and treatment by visit.","outcome_measure":"Change from BL in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at Day 168","outcome_time_frame":"BL to Day 168","outcome_safety_issue":null},{"outcome_description":"Participants were given daily record cards for daily completion from BL (Week -1) through Week 24 (Visit 6) each morning and prior to taking study medication (i.e., single-blind and double-blind study medication) supplemental medication (albuterol [salbutamol] if received) and ipratropium bromide (if received). Participants recorded number of occasions supplemental albuterol/salbutamol (MDI and/or nebules) used over the previous 24 hours and any medical problems that they had experienced and any medication used to treat these medical problems over the previous 24 hours. Analysis was performed using an analysis of covarience (ANCOVA) model with covariates of treatment, BL mean of occasions of rescue medication use (Week -1), history of exacerbation, and geographical region.","outcome_measure":"Mean number of occasions rescue medication [albuterol (salbutamol)] used during a 24-hour period averaged over the entire 24-week Treatment Period","outcome_time_frame":"BL (Week -1), Week 1 to Week 24","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"GlaxoSmithKline","collaborators":[]},"start_date":"03/04/2011 00:00:00","study_type":"Interventional","therapeutic_area":"Respiratory","citations":[{"citation":"Surya P. Bhatt, Mark T. Dransfield, John R. Cockcroft, Jie Wang-Jairaj, Dawn A. Midwinter, David B. Rubin, Catherine A. Scott-Wilson, Courtney Crim. A randomized trial of once-daily fluticasone furoate/vilanterol or vilanterol versus placebo to determine effects on arterial stiffness in COPD. Int J Chron Obstruct Pulmon Dis. 2017;12:351-365.","is_results_ref":"","pubmed_id":""}],"is_section_801":true}},"pageContext":{"studyId":"113108"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}