A large global prospective, observational study in obstructive lung disease, AstraZeneca’s NOVELTY (NOVEL observational longiTudinal study of patients with asthma and/or COPD) study is an innovative new study that aims to enhance disease understanding and support future development of personalised treatment strategies by highlighting unmet clinical needs in particular groups of asthma and COPD patients, including those with overlapping disease.
Redefining Respiratory Disease Research
Randomised controlled trials are central to testing investigational and new treatments, but they are only able to study a small proportion of patients.1,2 This means that the vast majority of patients with asthma and COPD are not represented in current studies, and represent a significant gap in our understanding of these conditions. NOVELTY is designed to provide real-world data across the spectrum of patients with asthma and/or COPD.
This broad view allows the inclusion of patients with a dual diagnosis of asthma and COPD, as well as those with a suspected diagnosis and mild or moderate disease – all groups usually excluded from conventional clinical trials but more common in the real-world population.1,2,3
As respiratory therapy continues to advance and we learn more about the drivers of diseases such as asthma and COPD, it will be crucial that we ensure the right patients get the right treatment, and NOVELTY is one step forward toward this goal. Our long-term goal is that NOVELTY will help improve patient care by allowing us to help develop treatments that target these diseases in ways we can’t right now.
Truly global, NOVELTY is being conducted in more than 17 countries all over the world and will follow patients for three years. Throughout the study duration, our goal is to assess not only patient characteristics, treatment patterns and disease progression, but also underlying disease mechanisms. The innovative study is designed to allow us to characterise patients and their response to treatments in two ways: based on either phenotype (symptoms and history) or endotype (the fundamental underlying biological mechanism of their disease). Most importantly, endotypes may present potential targets of therapy for specific patient groups – as some key biological pathways such as eosinophil count already do – and may offer novel new ways of treating asthma and COPD.
Importantly, NOVELTY also aims to open a pathway of collaboration with researchers around the world. As just the first step, it will not only offer a wealth of patient data for research and development purposes, but will also provide the foundation for additional modular studies in specific disease populations over time. Visit AZNoveltyProject.com for more information.
1. Travers J, et al. External validity of randomized controlled trials in COPD. Respiratory Medicine (2007) 101, 1313–1320.
2. Travers J, et al. External validity of randomised controlled trials in asthma: to whom do the results of the trials apply? Thorax 2007;62:219–223.
3. Bateman ED, et al. The asthma–COPD overlap syndrome: towards a revised taxonomy of chronic airways diseases? Lancet Respir Med 2015; 3: 719-28.