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Proposal 1630

Title of the Proposed Research

A framework for individualized prediction of the rate and severity of asthma exacerbations

Lead Researcher

Mohsen Sadatsafavi

Affiliation

Faculty of Pharmaceutical Sciences and Faculty of Medicine, University of British Columbia

Funding Source

The investigators of the proposed study are Theme Leaders of the Health Economics Platform of CRRN with a secured share of the CRRN budget.

Potential Conflicts of Interest

None

Data Sharing Agreement Date

12 June 2017

Lay Summary

Asthma is a chronic disease of the lungs that affects more than 300 million people across the world. Daily symptoms such as cough and shortness of breath are common features of asthma. In addition, periods of high disease activity, referred to as asthma exacerbations (or ‘lung attacks’) exert a high toll on patients as well as healthcare resources. Exacerbations are the main reasons for asthma-related visits to emergency departments, hospitalizations, or death.

Understanding the differences among asthma patients in their pattern of exacerbations will be important in many ways. Such understanding not only improve our understanding of the disease mechanisms, but also help us design ‘individualized’ asthma management plans that take into account each patient’s unique features.

Asthma patients might be different in at least two important ways about exacerbations. First, some patients frequently exacerbate, while the others do not. Second, there might be some patients in whom exacerbations are mostly mild, whereas some other patients might have a tendency towards experiencing severe exacerbations. The overall burden of exacerbations in an asthma patient is indeed affected by how often they experience them, and how severe they are when they occur.

Unfortunately, there is currently little information about how the occurrence and severity of exacerbations are different among different patients. Our research group has recently developed a method that can be used for the following purposes:

• Identifying the full spectrum of variability in rate and severity of exacerbations
• Testing whether those who exacerbate more often also tend to experience more severe exacerbations

We proposed to use the high quality data of the DREAM and MENSA studies to address these questions for the first time in asthma. This study builds on our success in addressing similar questions in patients with chronic obstructive pulmonary disease (COPD).

This study will provide important insights into how patients with asthma differ from each other in important aspects of their disease (especially in terms of exacerbations). Answer to the question “whether those who exacerbate a lot tend to have more severe exacerbation” is also important in our understanding of asthma. Results from this study can be used to make individualized prediction models of asthma exacerbations. Findings from this study will be presented at academic conferences and will be published in peer-reviewed journals. Once this project is finished, we will consider using other data to validate the mathematical equations from this work that can predict the pattern of future exacerbations in asthma patients.

Overall, this study has the potential to significantly contribute to the understanding of asthma. Also, it has high potential to impact patient care by enabling care providers to make patient-specific predictions about the future patterns of asthma exacerbations.

Study Data Provided

GSK-MEA112997: A multicenter, randomized, double-blind, placebo-controlled, parallel group, dose ranging study to determine the effect of mepolizumab on exacerbation rates in subjects with severe uncontrolled refractory asthma
GSK-MEA115588: MEA115588 A randomised, double-blind, double-dummy, placebo-controlled, parallel-group, multi-centre study of the efficacy and safety of mepolizumab adjunctive therapy in subjects with severe uncontrolled refractory asthma
GSK-MEA115575: MEA115575: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Mepolizumab Adjunctive Therapy to Reduce Steroid Use in Subjects with Severe Refractory Asthma
GSK-MEA115661: MEA115661: A Multi-centre, Open-label, Long-term Safety Study of Mepolizumab in Asthmatic Subjects who participated in the MEA115588 or MEA115575 trials

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.