TY - JOUR
T1 - A prospective cohort study to assess obstructive respiratory disease phenotypes and endotypes in Japan
T2 - The trait study design
AU - Hizawa, Nobuyuki
AU - Fukunaga, Koichi
AU - Sugiura, Hisatoshi
AU - Nakano, Yasutaka
AU - Kato, Motokazu
AU - Sugiyama, Yutaro
AU - Hanazawa, Tomohiro
AU - Kaise, Toshihiko
AU - Tal-Singer, Ruth
AU - Jones, Paul W.
AU - Barnes, Neil
AU - Compton, Chris
AU - Ishii, Takeo
N1 - Funding Information:
This study is funded by GSK (Study 212311). The funder of the study had a role in the study design, data analysis, data interpretation, and writing of the report.
Publisher Copyright:
© 2021 Hizawa et al.
PY - 2021
Y1 - 2021
N2 - Background: Asthma, chronic obstructive pulmonary disease (COPD), and asthma–COPD overlap (ACO) are complex and heterogeneous diseases that share clinical characteristics (phenotypes) and molecular mechanisms (endotypes). Whilst physicians make clinical decisions on diagnostic groups, for some such as ACO there is no commonly accepted criteria. An alternative approach is to evaluate phenotypes and endotypes that are considered to respond well to a specific type of treatment (“treatable traits”) rather than diagnostic labels. Purpose: The prospective, longitudinal, and observational TRAIT study will evaluate disease characteristics, including both phenotypes and endotypes, in relation to the presentation of obstructive respiratory disease characteristics in patients diagnosed with asthma, COPD, or ACO in Japan, with the aim of further understanding the clinical benefit of a treatable traits-based approach. Patients and Methods: A total of 1500 participants will be enrolled into three cohorts according to their treating physician’s diagnosis of asthma, COPD, or ACO at screening. Part 1 of the study will involve cross-sectional phenotyping and endotyping at study enrollment. Part 2 of the study will evaluate the progression of clinical characteristics, biomarker profiles, and treatment over a 3-year follow-up period. The follow-up will involve three annual study visits and three telephone calls scheduled at 6-month intervals. A substudy involving 50 participants from the asthma cohort (in which the ratio will be approximately 1:1 including 25 participants with a smoking history of ≥10 pack-years and 25 participants with no smoking history), 100 participants from the ACO cohort, and 100 participants from the COPD cohort will evaluate disease phenotypes using inspiratory and expiratory computed tomography scans. Conclusion: TRAIT will describe clinical characteristics of patients with obstructive respiratory diseases to better understand potential differences and similarities between clinical diagnoses, which will support the improvement of personalized treatment strategies.
AB - Background: Asthma, chronic obstructive pulmonary disease (COPD), and asthma–COPD overlap (ACO) are complex and heterogeneous diseases that share clinical characteristics (phenotypes) and molecular mechanisms (endotypes). Whilst physicians make clinical decisions on diagnostic groups, for some such as ACO there is no commonly accepted criteria. An alternative approach is to evaluate phenotypes and endotypes that are considered to respond well to a specific type of treatment (“treatable traits”) rather than diagnostic labels. Purpose: The prospective, longitudinal, and observational TRAIT study will evaluate disease characteristics, including both phenotypes and endotypes, in relation to the presentation of obstructive respiratory disease characteristics in patients diagnosed with asthma, COPD, or ACO in Japan, with the aim of further understanding the clinical benefit of a treatable traits-based approach. Patients and Methods: A total of 1500 participants will be enrolled into three cohorts according to their treating physician’s diagnosis of asthma, COPD, or ACO at screening. Part 1 of the study will involve cross-sectional phenotyping and endotyping at study enrollment. Part 2 of the study will evaluate the progression of clinical characteristics, biomarker profiles, and treatment over a 3-year follow-up period. The follow-up will involve three annual study visits and three telephone calls scheduled at 6-month intervals. A substudy involving 50 participants from the asthma cohort (in which the ratio will be approximately 1:1 including 25 participants with a smoking history of ≥10 pack-years and 25 participants with no smoking history), 100 participants from the ACO cohort, and 100 participants from the COPD cohort will evaluate disease phenotypes using inspiratory and expiratory computed tomography scans. Conclusion: TRAIT will describe clinical characteristics of patients with obstructive respiratory diseases to better understand potential differences and similarities between clinical diagnoses, which will support the improvement of personalized treatment strategies.
KW - ACO
KW - Asthma
KW - Biomarkers
KW - COPD
KW - Personalized medicine
KW - Treatable traits
UR - http://www.scopus.com/inward/record.url?scp=85109358820&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85109358820&partnerID=8YFLogxK
U2 - 10.2147/COPD.S308327
DO - 10.2147/COPD.S308327
M3 - Article
C2 - 34168442
AN - SCOPUS:85109358820
SN - 1176-9106
VL - 16
SP - 1813
EP - 1822
JO - International Journal of COPD
JF - International Journal of COPD
ER -
