An Update on Outcomes for COPD Pharmacological Trials: A COPD Investigators Report - Reassessment of the 2008 American Thoracic Society/European Respiratory Society Statement on Outcomes for COPD Pharmacological Trials

Cazzola, Mario; Rogliani, Paola; Barnes, Peter J.; Blasi, Francesco; Celli, Bartolomé R.; Hanania, Nicola A.; Martínez, Fernando J.; Miller, Bruce E.; Miravitlles, Marc; Page, Clive; Tal‐Singer, Ruth; Matera, Maria Gabriella

doi:10.1164/rccm.202303-0400so

Cited by 10 publications

(4 citation statements)

References 159 publications

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“…Gender refers to the socially constructed characteristics of women and men that determine roles and relationships across an individual lifetime ( 10 , 11 ). Understanding sex- and gender-differences and similarities in COPD is increasingly relevant given the growing focus on “treatable traits” and phenotyping patients ( 12 , 13 ). There is mounting awareness that COPD is a heterogenous disease and that sex may play a role in the symptoms, clinical presentation, and outcomes of patients.…”

Section: Sex In Copdmentioning

confidence: 99%

Sex-differences in COPD: from biological mechanisms to therapeutic considerations

Milne,

Mitchell,

Ferguson

et al. 2024

Front. Med.

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Chronic obstructive pulmonary disease (COPD) is a heterogeneous respiratory condition characterized by symptoms of dyspnea, cough, and sputum production. We review sex-differences in disease mechanisms, structure-function-symptom relationships, responses to therapies, and clinical outcomes in COPD with a specific focus on dyspnea. Females with COPD experience greater dyspnea and higher morbidity compared to males. Imaging studies using chest computed tomography scans have demonstrated that females with COPD tend to have smaller airways than males as well as a lower burden of emphysema. Sex-differences in lung and airway structure lead to critical respiratory mechanical constraints during exercise at a lower absolute ventilation in females compared to males, which is largely explained by sex differences in maximum ventilatory capacity. Females experience similar benefit with respect to inhaled COPD therapies, pulmonary rehabilitation, and smoking cessation compared to males. Ongoing re-assessment of potential sex-differences in COPD may offer insights into the evolution of patterns of care and clinical outcomes in COPD patients over time.

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Section: Sex In Copdmentioning

confidence: 99%

Sex-differences in COPD: from biological mechanisms to therapeutic considerations

Milne,

Mitchell,

Ferguson

et al. 2024

Front. Med.

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“… 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. 9 This approach does not allow the personalisation of COPD treatment, which must still be considered empirical despite attempts to move towards a more individualised treatment. Few patients are responsive to all the drugs available for COPD treatment.…”

Section: Clinical Phenotypes and Endotypesmentioning

confidence: 99%

“…For this reason, it is recommended that new clinical trials focus on prevalent treatable traits. 9 Obviously, if this happens, the outcomes and parameters to be considered will be influenced by the choice of treatable traits. These studies can be a way to provide needed information on treatment efficacy in a personalised medicine context.…”

Section: Treatable Traits Approachmentioning

confidence: 99%

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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“…An outcome measure of a clinical trial should reflect the effects of the disease on the individual rather than the structural abnormality caused by their condition. A consensus-based outcomes review supported by the American Thoracic Society and the European Respiratory Society proposed a more sophisticated approach to pharmacological trial endpoints that focuses on highly prevalent treatable traits, such as reduced exercise tolerance ( 4 ). In line with this approach, clinical trials in pulmonary rehabilitation have traditionally reported a range of outcomes to reflect the key treatable traits in COPD, and this has recently been endorsed with a core outcome dataset ( 5 ).…”

mentioning

confidence: 99%

Are the Brakes Off for Constant Work Rate Exercise Tests to Be Used in Regulatory Decision Making in Chronic Obstructive Pulmonary Disease?

Baldwin,

Singh

2024

Annals ATS

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An Update on Outcomes for COPD Pharmacological Trials: A COPD Investigators Report - Reassessment of the 2008 American Thoracic Society/European Respiratory Society Statement on Outcomes for COPD Pharmacological Trials

Cited by 10 publications

References 159 publications

Sex-differences in COPD: from biological mechanisms to therapeutic considerations

Sex-differences in COPD: from biological mechanisms to therapeutic considerations

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

Are the Brakes Off for Constant Work Rate Exercise Tests to Be Used in Regulatory Decision Making in Chronic Obstructive Pulmonary Disease?

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