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Relationship Between Baseline Blood Electrolyte Levels and Risk of Asthma Exacerbation

Relationship Between Baseline Blood Electrolyte Levels and Risk of Asthma Exacerbation

Greg Opitek

Gossamer Bio

26 February 2020

Asthma is a heterogeneous disease that responds only partially to currently available therapies. These therapies aim to improve lung function and to reduce inflammation and the risk of exacerbations. Patients with asthma that is characterized by high levels of blood eosinophils and/or fractional exhaled nitric oxide, both of which are markers of inflammation, are more likely to respond well to therapies that inhibit inflammation. That still leaves a substantial proportion of asthma patients who don't benefit from these therapies. Electrolyte imbalances are observed more frequently in patients with asthma than individuals without asthma. The most prevalent electrolyte imbalances were hypokalemia, hypomagnesemia, and hypophosphatemia. Several reports from animal studies indicate that electrolyte levels can directly influence the activity of airway smooth muscles. These findings suggest that electrolyte levels could potentially be associated with asthma exacerbations.An exploratory analysis of data from asthma studies on file at Gossamer Bio suggests a potential relationship between risk of exacerbation and serum electrolytes. This observation was made in a relatively small study (approximately 50 patients in each of 3 treatment groups) and our goal is to confirm the results in larger study populations. The two studies (MEA112997/NCT01000506 and MEA115588/NCT01691521) were chosen because they use exacerbations as a primary endpoint and were larger (approximately 150 patients and 190 patients, respectively, in each treatment group). We will test the following null hypotheses:-   Electrolyte levels are unrelated to rate of exacerbation.-   Electrolyte levels do not change over time.-   Treatment with mepolizumab does not modify electrolyte levels.-   At baseline, electrolyte levels are unrelated to eosinophils and to FeNO.If an association between electrolyte levels and risk of asthma exacerbation is found, other avenues of patient management may become available that include adjustments to current medications and dietary changes.

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Statistical Analysis Plan