CompEx Asthma: is it time for a change in clinical trials?

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Abstract
Asthma is a heterogeneous disease. It is usually characterised by chronic airway inflammation and is defined by a history of respiratory symptoms and variable expiratory airflow limitation [1, 2]. Despite the significant advances in asthma treatment over recent years, a proportion of patients remain uncontrolled [3]. To achieve the best possible long-term outcomes for patients with asthma, new approaches are needed to improve treatment access [2]. In clinical trials, robust endpoints or outcome measures are essential to assess the efficacy and safety of the study intervention; however, asthma represents a challenge in study design because of disease control existing across multiple domains, including exacerbations, lung function as measured by spirometry (or peak flow), reliever inhaler use and symptoms. Specifically, to achieve clinical asthma remission, treatments are required that result in patients having no symptoms, no oral corticosteroid use, stable or improving lung function, and an absence of exacerbations [2]. The recent influx of approved biologics in severe asthma have mostly relied on severe exacerbations as an endpoint in pivotal studies.
Funding Information
  • AstraZeneca

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