Treatment Trials in Young Patients with Chronic Obstructive Pulmonary Disease and Pre-Chronic Obstructive Pulmonary Disease Patients: Time to Move Forward

Chronic obstructive pulmonary disease (COPD) is the end result of a series of dynamic and cumulative gene-environment interactions over a lifetime. The evolving understanding of COPD biology provides novel opportunities for prevention, early diagnosis, and intervention. To advance these concepts, we...

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Vydané v:American journal of respiratory and critical care medicine Ročník 205; číslo 3; s. 275
Hlavní autori: Martinez, Fernando J, Agusti, Alvar, Celli, Bartolome R, Han, MeiLan K, Allinson, James P, Bhatt, Surya P, Calverley, Peter, Chotirmall, Sanjay H, Chowdhury, Badrul, Darken, Patrick, Da Silva, Carla A, Donaldson, Gavin, Dorinsky, Paul, Dransfield, Mark, Faner, Rosa, Halpin, David M, Jones, Paul, Krishnan, Jerry A, Locantore, Nicholas, Martinez, Fernando D, Mullerova, Hana, Price, David, Rabe, Klaus F, Reisner, Colin, Singh, Dave, Vestbo, Jørgen, Vogelmeier, Claus F, Wise, Robert A, Tal-Singer, Ruth, Wedzicha, Jadwiga A
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: United States 01.02.2022
Predmet:
Adult
Age Factors
Disease Progression
Early Diagnosis
Humans
Middle Aged
Outcome Assessment, Health Care - methods
Pulmonary Disease, Chronic Obstructive - diagnosis
Pulmonary Disease, Chronic Obstructive - therapy
Randomized Controlled Trials as Topic - methods
Research Design
clinical trials
young age
early
pre-COPD
COPD
ISSN:1535-4970, 1535-4970
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Shrnutí:Chronic obstructive pulmonary disease (COPD) is the end result of a series of dynamic and cumulative gene-environment interactions over a lifetime. The evolving understanding of COPD biology provides novel opportunities for prevention, early diagnosis, and intervention. To advance these concepts, we propose therapeutic trials in two major groups of subjects: "young" individuals with COPD and those with pre-COPD. Given that lungs grow to about 20 years of age and begin to age at approximately 50 years, we consider "young" patients with COPD those patients in the age range of 20-50 years. Pre-COPD relates to individuals of any age who have respiratory symptoms with or without structural and/or functional abnormalities, in the absence of airflow limitation, and who may develop persistent airflow limitation over time. We exclude from the current discussion infants and adolescents because of their unique physiological context and COPD in older adults given their representation in prior randomized controlled trials (RCTs). We highlight the need of RCTs focused on COPD in young patients or pre-COPD to reduce disease progression, providing innovative approaches to identifying and engaging potential study subjects. We detail approaches to RCT design, including potential outcomes such as lung function, patient-reported outcomes, exacerbations, lung imaging, mortality, and composite endpoints. We critically review study design components such as statistical powering and analysis, duration of study treatment, and formats to trial structure, including platform, basket, and umbrella trials. We provide a call to action for treatment RCTs in ) young adults with COPD and ) those with pre-COPD at any age.
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ISSN:1535-4970
1535-4970
DOI:10.1164/rccm.202107-1663SO