The Observational and Pragmatic Research Institute is proud to announce the launch of the Pragmatic Evaluation of an Improvement Program for People Living with Modifiable High-risk COPD (PREVAIL) study, in collaboration with AstraZeneca and Optimum Patient Care. PREVAIL is the first efficacy trial to assess the clinical outcomes of the CONQUEST quality improvement program for patients with chronic obstructive pulmonary disease (COPD). PREVAIL specifically targets patients at modifiable high risk of exacerbations with a current diagnosis of COPD, a spectrum of progressive lung diseases that include chronic bronchitis and emphysema, and those undiagnosed but with potential COPD.
PREVAIL’s objective is to evaluate the CONQUEST quality improvement program on key health outcomes in the US and UK independently, with a target follow-up period of 2 and 2.5 years respectively. This study will contribute to the understanding of the impact of earlier detection of COPD and optimized non-pharmacological and pharmacological intervention on patient prognosis in modifiable high-risk COPD patients.
Given the established relationship between the risk of major cardiac events and exacerbations, PREVAIL’s primary outcomes will be the occurrence of COPD exacerbations and major adverse cardiovascular or respiratory events (MACRE) during the course of the trial, alongside the evaluation of other important COPD health outcomes.1,2 PREVAIL aims to accelerate research and stimulate innovation in COPD patient management in primary care.
John Hurst (Global Steering Committee Member and Professor of Respiratory Medicine at University College London), said: “Previous studies have highlighted missed opportunities for improvement in this population of patients experiencing recurrent events. The design of the PREVAIL trial presents a unique opportunity to show the impact of targeting this population on major COPD health outcomes.’’
‘‘PREVAIL is novel in that it will, for the first time, use real world data to show the effectiveness of driving a new vision for targeted, risk-based treatment through enhanced clinical assessment’’, explained Professor David Price, the Founder and CEO of the Observational & Pragmatic Research Institute.
Gonzalo de Miquel, Vice President of Global Medical Affairs, AstraZeneca, said: “Our ambition at AstraZeneca is to modify COPD progression and ultimately eliminate it as a leading cause of death. Results from the PREVAIL trial will aid in characterising the impact of earlier detection and intervention of COPD, with the potential for improved patient outcomes.”
This trial builds on research led by the Observational and Pragmatic Research Institute since 2018, which has demonstrated that patients with COPD who experience repeated exacerbations:
- have worse lung function when first diagnosed with mild-to-moderate COPD and a more rapid lung function decline thereafter, despite maintenance therapy3
- show rapid COPD progression when not treated with inhaled corticosteroids despite high blood eosinophil counts4
- respond best to oral corticosteroid in the treatment of acute exacerbations if they have high blood eosinophil counts recorded3
These results have informed the development of the core components of the CONQUEST quality improvement program, guided by a Global Steering Committee of clinical experts. The components include clinical decision support to aid the identification and tracking of patients at higher but modifiable risk of exacerbations of COPD in whom there is scope for management optimization, and patients experiencing potential COPD exacerbations who are currently undiagnosed.
Chronic obstructive pulmonary disease (COPD) is a group of progressive lung diseases, of which the most common are emphysema and chronic bronchitis.5,6 While emphysema slowly destroys air sacs in the lungs, interfering with outward air flow, bronchitis causes inflammation and narrowing of bronchial tubes, which leads to mucus build-up.5,6 Common COPD symptoms include frequent coughing or wheezing, excess mucus production, shortness of breath and trouble taking a deep breath.5,6 The top cause of COPD is tobacco smoking, but long-term exposure to chemical irritants can also lead to COPD.5 Approximately 384 million people around the world have COPD7, but the number is likely much higher as >50% may be undiagnosed8. There is no cure for COPD, but treatment can help ease symptoms, lower the chance of complications, and generally improve quality of life.5 However, key opportunities to modify the COPD pathway are often missed due to delayed diagnosis and treatment. For example, as many as 85% of COPD patients have a lower respiratory consultation in the 5 years before diagnosis9, while the average age of maintenance therapy initiation is 68-71 years.10 COPD has a huge impact on patients’ lives, limiting their daily activities (i.e. difficulty walking or climbing stairs), ability to work, engage in social activities and increasing the likelihood of hospital stays, having other chronic diseases (e.g. heart failure, diabetes, coronary heart disease), depression and poor quality of life.5,11
About the Observational and Pragmatic Research Institute:
The Observational & Pragmatic Research Institute (OPRI) is an independent research institute distinguished in building and accessing global data sources to drive change in clinical practice around the world. OPRI delivers the real-world evidence through observational and pragmatic research which is required to improve patient lives. By collaborating with world-renowned clinical, academic and industry partners OPRI has published over 500 publications and is considered a dynamic and progressive company at the forefront of advances in global healthcare. More information can be found out about Observational & Pragmatic Research Institute at www.opri.sg.
- Kunisaki, K. M. et al. Exacerbations of Chronic Obstructive Pulmonary Disease and Cardiac Events. A Post Hoc Cohort Analysis from the SUMMIT Randomized Clinical Trial. Am. J. Respir. Crit. Care Med. 198, 51–57 (2018).
- Donaldson, G. C., Hurst, J. R., Smith, C. J., Hubbard, R. B. & Wedzicha, J. A. Increased risk of myocardial infarction and stroke following exacerbation of COPD. Chest 137, 1091–1097 (2010).
- Kerkhof M, Voorham J, Dorinsky P, Cabrera C, Darken P, Kocks JWH, et al. The Long-Term Burden of COPD Exacerbations During Maintenance Therapy and Lung Function Decline. Int J Chron Obstruct Pulmon Dis. 2020;15:1909–18.
- Kerkhof M, Voorham J, Dorinsky P, Cabrera C, Darken P, Kocks JW, et al. Association between COPD exacerbations and lung function decline during maintenance Thorax. 2020;75:744–53.
- World Health Organization. Chronic obstructive pulmonary disease (COPD). [Online]. Available at: https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd). [Last accessed: June 2020].
- Everything You Need to Know About Chronic Obstructive Pulmonary Disease (COPD). [Online]. Available at: https://www.healthline.com/health/copd. [Last accessed: July 2021].
- Adeloye D, Chua S, Lee C, et al. Global Health Epidemiology Reference Group (GHERG). Global and regional estimates of COPD prevalence: Systematic review and meta-analysis. J Glob Health. 2015; 5 (2): 020415.
- Haroon S, Adab P, Riley RD, Fitzmaurice D, Jordan RE. Predicting risk of undiagnosed COPD: development and validation of the TargetCOPD score. European Respiratory Journal. 2017 Jun 1;49(6).
- Jones, R. C. M.; Price, D.; Ryan, D.; Sims, E. J.; von Ziegenweidt, J.; Mascarenhas, L.; Burden, A.; Halpin, D. M. G.; Winter, R.; Hill, S.; Kearney, M.; Holton, K.; Moger, A.; Freeman, D.; Chisholm, A.; Bateman, E. D.; Respiratory Effectiveness Group. Opportunities to Diagnose Chronic Obstructive Pulmonary Disease in Routine Care in the UK: A Retrospective Study of a Clinical Cohort. Lancet Respir. Med. 2014, 2 (4), 267–276. https://doi.org/10.1016/S2213-2600(14)70008-6.
- Halpin DM, de Jong HJ, Carter V, Skinner D, Price D. Distribution, temporal stability and appropriateness of therapy of patients with COPD in the UK in relation to GOLD 2019. EClinicalMedicine. 2019 Sep 1;14:32-41.
- Miravitlles M, Ribera A. Understanding the impact of symptoms on the burden of COPD. Respiratory research. 2017 Dec;18(1):1-1.