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Njira L Lugogo,1 Michael DePietro,2 Michael Reich,3 Rajan Merchant,4 Henry Chrystyn,5 Roy Pleasants,6 Lena Granovsky,3 Thomas Li,2 Tanisha Hill,2 Randall W Brown,2 Guilherme Safioti7 1Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Michigan, Ann Arbor, MI, USA; 2Teva Branded Pharmaceutical Products R&D Inc, Parsippany, NJ, USA; 3Teva Pharmaceutical Industries Ltd, Tel Aviv, Israel; 4Woodland Clinic Medical Group, Allergy Department, Dignity Health, Woodland, CA, USA; 5Inhalation Consultancy Ltd, Leeds, UK; 6Population Health, University of Michigan, Ann Arbor, MI and Division of Pulmonary Disease and Critical Care Medicine, University of North Carolina at Chapel Hill, School of Medicine, Chapel Hill, NC, USA; 7Teva Pharmaceuticals Europe B.V, Amsterdam, the NetherlandsCorrespondence: Njira L Lugogo, Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Michigan, 300 North Ingalls St, Suite 2C40, Ann Arbor, MI, 48109, USA, Tel +1 734 647 6477, Email nlugogo@med.umich.eduPurpose: Machine learning models informed by sensor data inputs have the potential to provide individualized predictions of asthma deterioration. This study aimed to determine if data from an integrated digital inhaler could be used to develop a machine learning model capable of predicting impending exacerbations.Patients and Methods: Adult patients with poorly controlled asthma were enrolled in a 12-week, open-label study using ProAir® Digihaler®, an electronic multi-dose dry powder inhaler (eMDPI) with integrated sensors, as reliever medication (albuterol, 90 μg/dose; 1â 2 inhalations every 4 hours, as needed). Throughout the study, the eMDPI recorded inhaler use, peak inspiratory flow (PIF), inhalation volume, inhalation duration, and time to PIF. A model predictive of impending exacerbations was generated by applying machine learning techniques to data downloaded from the inhalers, together with clinical and demographic information. The generated model was evaluated by receiver operating characteristic area under curve (ROC AUC) analysis.Results: Of 360 patients included in the predictive analysis, 64 experienced a total of 78 exacerbations. Increased albuterol use preceded exacerbations; the mean number of inhalations in the 24-hours preceding an exacerbation was 7.3 (standard deviation 17.3). The machine learning model, using gradient-boosting trees with data from the eMDPI and baseline patient characteristics, predicted an impending exacerbation over the following 5 days with an ROC AUC of 0.83 (95% confidence interval: 0.77â 0.90). The feature of the model with the highest weight was the mean number of daily inhalations during the 4 days prior to the day the prediction was made.Conclusion: A machine learning model to predict impending asthma exacerbations using data from the eMDPI was successfully developed. This approach may support a shift from reactive care to proactive, preventative, and personalized management of chronic respiratory diseases.Keywords: digital inhalers, machine learning, personalized medicine, predictive modeling |
