Asthma Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Mono-center Study to Evaluate the Effects of Mepolizumab on Airway Physiology in Patients With Eosinophilic Asthma: the MEMORY Study
The purpose of the MEMORY trial is to compare the effects of mepolizumab with Placebo on airway physiology in patients with eosinophilic asthma
Asthma with eosinophilic inflammation in the airways and/or blood eosinophilia is associated
with clinical severity including the risk of exacerbations and relevant comorbidities (e.g.
nasal polyposis). Interleukin-5 (IL-5) is a cytokine essential for eosinophil trafficking and
survival. Clinical trials of blocking IL-5 with anti-IL-5 antibodies (mepolizumab and
reslizumab) in patients with uncontrolled eosinophilic asthma resulted in an improvement in
exacerbation rate and oral corticosteroid use. In some studies with mepolizumab and
reslizumab there was a beneficial effect on lung function (FEV1). In addition, many patients
described a profound impact on asthma symptoms and quality of life in personal reports which
is not uniformly reflected in clinical trials.
The MEMORY trial is the first to primarily evaluate the effect of mepolizumab treatment on
pulmonary function in patients with severe eosinophilic asthma. Importantly, using spirometry
and bodyplethysmography will allow to evaluate additional parameters beyond FEV1 that more
closely mirror the pathophysiological changes and functional aspects of airflow limitation in
asthma in real life, e.g. airway resistance, hyperinflation and diffusion capacity. The
proposed trial will answer the important questions: if, and if so, which parameters of airway
(patho-) physiology as assessed by bodyplethysmography best reflect clinical response to
mepolizumab therapy in patients with severe eosinophilic asthma. In addition, the time course
to clinical response will be assessed. Equally important, there is only a loose correlation
between FEV1 and parameters of asthma control and asthma-related quality of life. This is why
another new and important aspect of this trial is to carefully monitor asthma control and
asthma quality in life in correlation with lung function changes beyond FEV1. Finally, it is
tempting to speculate that the proposed trial will contribute to the question how to best
define clinical response to mepolizumab.
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