Effect of Fluticasone Furoate/Vilanterol Inh. Powder 100/25mcg in COPD

• Research type

  Research Study

• Full title

  A Clinical Outcomes Study to compare the effect of Fluticasone Furorate/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.

• IRAS ID

  69998

• Sponsor organisation

  GlaxoSmithKline Research and Development Ltd

• Eudract number

  2010-021638-72

• Clinicaltrials.gov Identifier

  NCT 0131376

• Research summary

  GlaxoSmithKline, the sponsor of this study, is conducting this study to investigate the effect ofluicasone Furoate (FF)/Vilanterol (VI) inhalation powder on survival in participants with moderate COPD with a history of or at increased risk for cardiovascular disease (CD). Approximately 16,000 participants will be involved in approximately 1200 study centers globally. The study duration is estimated between 15 and 44 months.Following a run in period, eligible participants will be randomly assigned to 1 of 4 treatment groups receiving one of the following once daily:?FF/VI 100mcg/25mcg?FF 100mcg?VI 25mcg?Sugar PillThis study is blinded: Neither the participant nor his/her doctor or the study team will know what treatment is given.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  11/NW/0338

• Date of REC Opinion

  11 Jul 2011

• REC opinion

  Further Information Favourable Opinion