Functional imaging in asthma and COPD: design of the NOVELTY ADPro substudy.

The NOVEL observational longiTudinal studY (NOVELTY; ClinicalTrials.gov identifier NCT02760329) is a global, prospective, observational study of ∼12 000 patients with a diagnosis of asthma and/or COPD. Here, we describe the design of the Advanced Diagnostic Profiling (ADPro) substudy of NOVELTY being conducted in a subset of ∼180 patients recruited from two primary care sites in York, UK. ADPro is employing a combination of novel functional imaging and physiological and metabolic modalities to explore structural and functional changes in the lungs, and their association with different phenotypes and endotypes. Patients participating in the ADPro substudy will attend two visits at the University of Sheffield, UK, 12±2 months apart, at which they will undergo imaging and physiological lung function testing. The primary end-points are the distributions of whole lung functional and morphological measurements assessed with xenon-129 magnetic resonance imaging, including ventilation, gas transfer and airway microstructural indices. Physiological assessments of pulmonary function include spirometry, bronchodilator reversibility, static lung volumes

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Déclaration de conflit d'intérêts

Conflict of interest: H. Marshall, J. Wild and L. Smith are employees of the University of Sheffield, who received funding to conduct the study. H. Marshall has received support for attending meetings from AstraZeneca. T. Fihn-Wikander and H. Müllerová are employees of AstraZeneca. R. Hughes has received personal fees from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and Novartis outside of the submitted work, and is an employee of AstraZeneca. L. Hardaker has no conflicts to disclose.