The Salford Lung Study protocol: a pragmatic, randomised phase III real-world effectiveness trial in asthma

Abstract

Background: Novel therapies need to be evaluated in normal clinical practice to allow a true representation of the treatment effectiveness in real-world settings.

Methods/design: The Salford Lung Study is a pragmatic randomised controlled trial in adult asthma, evaluating the clinical effectiveness and safety of once-daily fluticasone furoate (100 μg or 200 μg)/vilanterol 25 μg in a novel dry-powder inhaler, versus existing asthma maintenance therapy. The study was initiated before this investigational treatment was licensed and conducted in real-world clinical practice to consider adherence, co-morbidities, polypharmacy, and real-world factors.

Primary endpoint: Asthma Control Test at week 24; safety endpoints include the incidence of serious pneumonias. The study utilises the Salford electronic medical record, which allows near to real-time collection and monitoring of safety data.

Discussion: The Salford Lung Study is the world's first pragmatic randomised controlled trial of a pre-licensed medication in asthma. Use of patients' linked electronic health records to collect clinical endpoints offers minimal disruption to patients and investigators, and also ensures patient safety. This highly innovative study will complement standard double-blind randomised controlled trials in order to improve our understanding of the risk/benefit profile of fluticasone furoate/vilanterol in patients with asthma in real-world settings.

Trial registration: Clinicaltrials.gov, NCT01706198; 04 October 2012.

Fig. 1

Study design. *Cardiovascular risk factors collected. ^†Comprises: Asthma Control Test; Asthma Quality of Life Questionnaire(s); EuroQol questionnaire; Medication Adherence Report Scale for Asthma; Work Productivity and Activity Impairment Questionnaire: Asthma. FF fluticasone furoate; GP general practitioner; ICS inhaled corticosteroid; LABA long-acting β₂-agonist; VI vilanterol