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 utili

SUBMITTER: Woodcock A 

PROVIDER: S-EPMC4676141 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature