Identification of severe, uncontrolled asthma patients in clinical practice: an enriched methodology-based study – protocol status

Background Uncontrolled severe asthma often remains unidentified in clinical practice. There is clearly an unmet need to identify patients with uncontrolled severe asthma and design new strategies to improve and sustain asthma control.

Aim To identify patients with severe, uncontrolled asthma in routine practice and assess changes in asthma control, treatment patterns, health outcomes, and environmental influences over a 24-month follow-up through an innovative study design using 3 integrated methods of data collection.

Methods The study population comprises severe (Global Initiative for Asthma [GINA] step 4/5), uncontrolled asthma patients according to GINA guidelines. An enriched methodology based on the combination of 3 integrated data sources is applied: an electronic medical record (EMR) to collect relevant study information; an electronic case report form (eCRF) to capture additional data; and the smartphone SaniQ App, to gather patients’ self-reported information and environmental factors. A software containing defined trigger criteria based on WHO ICD-10 diagnosis codes and prescribed medication is used in clinical practice to help physicians identify eligible participants from the EMR. This software additionally captures patients baseline and follow-up information directly from the EMR. Information that is not captured by the software is provided by physicians via an eCRF. Lastly, a modified version of the SaniQ Lung App “AIRQ-Active” — an easy-to-use patient smartphone app in special configuration for lung diseases — collects patients’ information on asthma control, medication intake and physical activity. The study outcome is the number of severe asthma patients at risk of exacerbation, assessed by the Impairment and Risk Questionnaire (AIRQ). The AIRQ is a 10-item validated asthma control tool that assesses both symptom impairment and exacerbation risk. Additional outcomes are changes in medication use, physical activity, quality of life and environmental factors. This innovative, patient-centered survey reduces the burden of data collection in daily routine, increases data quality, improves efficiency in patient selection and, for the first time, provides documentation of actual oral corticosteroids (OCS) use through a simply implemented digital self-report.

Publication History

Article published online:
09 March 2023