The Salford Lung Study (Asthma)

• 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 compared with usual maintenance therapy in subjects with Asthma.

• IRAS ID

  106072

• Contact name

  Ashley Woodcock

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2011-005553-31

• Research summary

  Asthma is a chronic lung disease characterised by inflammation (swelling and irritation), narrowing of the airways and by the airways being more responsive to irritation. Inhaled corticosteroids (ICS) are considered the most effective treatment for asthma by controlling symptoms, improving lung function, decreasing responsiveness to irritants and possibly stopping changes in airway wall structure caused by long term inflammation. <fluicasone furoate (FF), a novel glucocorticoid (ICS), and Vilanterol (VI), a long-acting agonist of the beta2-adrenoceptor (LABA), are being developed in combination as a once daily treatment for asthma. Current ICS/LABA combinations are taken twice daily; once-daily dosing may improve patient compliance and disease status. The pivotal phase III studies are key to demonstrating the safety and efficacy of FF/VI. However, the impact of a medication on healthcare use is hard to measure in standard clinical studies which are highly controlled, with defined visits and procedures resulting in a need for ??real-world?? evidence of a medication??s benefits in routine clinical practice. This study will compare the effectiveness and safety profile of FF/VI inhaled powder combination taken once daily against usual treatment in asthma patients in Salford, UK. Approximately 4820 subjects will be recruited. Subjects will attend 3 formal visits and will be contacted by telephone 3 times during the 12 month study. Details of healthcare contacts during the study will be captured. Assessments will include safety and exacerbation assessments and questionnaires. This study will use an integrated primary and secondary care Electronic Medical Record (EMR) unique to Salford. A linked database system has been developed to extract subject information from the EMR and other databases e.g. Office of National Statistics, in close to ??real-time??. This database will be reviewed daily for safety events and allows close to ??real-time?? monitoring and rapid follow up of subjects by a team of healthcare professionals.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  12/NW/0455

• Date of REC Opinion

  18 Jun 2012

• REC opinion

  Favourable Opinion