Abstract
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 chronic obstructive pulmonary disease (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 endpoints 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 via body plethysmography, transfer factor of the lung for carbon monoxide, multiple-breath nitrogen washout and airway oscillometry. Fractional exhaled nitric oxide will be measured as a marker of Type-2 airways inflammation.
Regional and global assessment of lung function using these techniques will enable more precise phenotyping of patients with physician-assigned asthma and/or COPD. These techniques will be assessed for their sensitivity to markers of early disease progression.
Footnotes
This manuscript has recently been accepted for publication in the ERJ Open Research. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJOR online. Please open or download the PDF to view this article.
Conflict of interest: H. Marshall, J. Wild and L. Smith are employees of 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.
This is a PDF-only article. Please click on the PDF link above to read it.
- Received July 12, 2022.
- Accepted December 17, 2022.
- Copyright ©The authors 2023
This version is distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0. For commercial reproduction rights and permissions contact permissions{at}ersnet.org
