The Salford Lung Study (COPD)

• Research type

  Research Study

• Full title

  A 12-month, open label, randomised, effectiveness study to evaluate fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) Inhalation Powder delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with the existing COPD maintenance therapy alone in subjects with Chronic Obstructive Pulmonary Disease (COPD).

• IRAS ID

  91164

• Contact name

  Ashley Woodcock

• Sponsor organisation

  GlaxoSmithKline Research & Development Ltd

• Eudract number

  2011-002452-13

• Research summary

  COPD is estimated to affect 600 million people worldwide and by 2020 it is expected to be the third leading cause of death. COPD has a significant impact on everyday activities and results in increased healthcare use by patients despite the use of existing treatments. Combined inhaled corticosteroid (ICS) with long acting Ç?2-agonist (LABA) has been shown to be more effective at stabilising COPD symptoms than when used separately. Current ICS/LABA combinations are taken twice daily; once-daily dosing may improve patient compliance and therefore disease status. The aim of this study is to compare the effectiveness and safety profile ofluicasone furoate (ICS)/vilanterol (LABA) inhaled powder combination taken once daily against existing maintenance treatment in COPD patients receiving maintenance medication. Approximately 4232 subjects will be recruited and remain in the study for 12 months. Subjects will attend 3 formal visits and may be contacted by telephone up to three times during the study. Details of any other healthcare contacts during the study will also be captured. Assessments performed will include lung function tests, safety assessments, exacerbation assessment and quality of life questionnaires. The impact of a medication on healthcare use is hard to measure in standard clinical studies as they are highly controlled, with defined visits and procedures. There is a need for more ??real-world?? evidence of a medication??s benefits in routine clinical practice. This study will use an integrated primary and secondary care Electronic Medical Record (EMR) in Salford, UK. A linked database system has been developed to extract subject information from the EMR and other databases e.g. Office of National Statistics, in as close to ??real-time?? as possible. This database will be checked daily for safety events and allows close to ??real-time?? monitoring and rapid follow up of study subjects by a dedicated team of healthcare professionals.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  11/NW/0798

• Date of REC Opinion

  10 Jan 2012

• REC opinion

  Further Information Favourable Opinion