Moving to a Personalized Approach in Respiratory Medicine. From Academic Research to Regulatory Intervention

Cazzola, Mario

doi:10.3389/fdsfr.2021.752581

Cited by 3 publications

(2 citation statements)

References 27 publications

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Section: Clinical Phenotypes and Endotypesmentioning

confidence: 99%

“…However, despite the considerable advances in omics technology and the role of omics in respiratory medicine, several methodological, practical, and ethical issues must be resolved before laboratory data can be translated into therapeutic applications. 7 Although obstructive airway diseases, and thus also COPD, are heterogeneous, meaning that all patients are different and can present with a wide range of symptoms and underlying factors, the pivotal randomised controlled trials (RCTs) used to approve each new drug do not take heterogeneity into account. 8 The evidence supporting the use of currently available therapies is based on the results of major Phase III RCTs, which tend to be large, involving thousands of COPD patients selected solely based on the degree of obstruction, smoking history, and a symptom questionnaire or history of exacerbations.…”

Section: Clinical Phenotypes and Endotypesmentioning

confidence: 99%

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Can Treatable Traits Be the Approach to Addressing the Complexity and Heterogeneity of COPD?

Cazzola,

Rogliani,

Blasi

2023

COPD

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The complexity of COPD implies the need to identify groups of patients with similar clinical characteristics and prognosis or treatment requirements. This is why much attention has been paid to identifying the different clinical phenotypes by investigating the clinical expression of the disease, and endotypes by studying the biological networks that enable and limit reactions. However, this approach is complicated because one endotype gives rise to one or more clinical characteristics, and clinical phenotypes can be derived from several endotypes. To simplify the approach, a new taxonomic classification of COPD based on the different causes (or etiotypes) has been proposed, but these etiotypes have not yet been validated. A simpler method is the so-called tractable traits approach, which is free from any designation of the disorder to be treated and does not present the criticality of using etiotypes. A large randomised controlled trial on using the treatable traits approach in COPD is still lacking. Nevertheless, this approach is already applied by following the GOLD strategy. However, its application is complicated because several potentially treatable traits have been identified within the pulmonary domain, the extrapulmonary domain, and the behavioural/risk factor domain. In addition, the hierarchy of the dominant treatable traits has not yet been established, and they change over time both spontaneously and because of treatment. This means that the patients being treated according to the tractable traits approach must be constantly followed over time so that the therapy is focused on their temporal needs.

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Section: Clinical Phenotypes and Endotypesmentioning

confidence: 99%

Section: Clinical Phenotypes and Endotypesmentioning

confidence: 99%