Real-World Evidence on the Diagnostic and Clinical Characteristics of Asthma in Japanese Patients with COPD: The ACO Japan Cohort Study

Abstract

Introduction

The ACO Japan Cohort Study, a multicenter observational study, investigated the proportion of patients with chronic obstructive pulmonary disease (COPD) who met the Japanese Respiratory Society (JRS) asthma–COPD overlap (ACO) diagnostic criteria, characteristics of ACO and non-ACO patients, and the patient transitions between ACO/non-ACO diagnosis over 2 years.

Patients and Methods

Patients with COPD were consecutively enrolled between June and December 2018 and followed up continuously for 2 years. All participating study sites were medical institutions where respiratory specialists routinely conducted medical examinations/tests required for ACO diagnosis.

Results

Among 708 patients with COPD, 101 (14.3%), 118 (16.7%), and 125 (17.7%) were diagnosed with ACO at registration, 1 year, and 2 years, respectively. In total, 22.6% of patients lacked the data necessary for ACO diagnosis throughout the 2 years. Among patients who had the necessary data for ACO diagnosis, 24.7% were diagnosed with ACO at 2 years. More ACO patients had moderate or severe exacerbations in the past year than non-ACO patients at registration (15.8% vs 6.3%, p = 0.049) and 1 year (19.4% vs 7.6%, p = 0.025). ACO patients had a greater decrease in mean forced expiratory volume in one second over 2 years than non-ACO patients (−92.0 vs 43.4 mL). Among patients diagnosed with ACO at registration, 21.4% transitioned to non-ACO after 1 year. Conversely, almost all non-ACO patients at registration remained non-ACO after 1 year.

Conclusion

COPD patients with ACO determined by the JRS criteria had a high risk of exacerbations and a rapid decline in respiratory function, indicating that the JRS criteria for ACO are useful for identifying high-risk COPD patients. Testing necessary for ACO diagnosis is insufficiently performed even in real-world clinical practice of COPD specialists.

Keywords:

• asthma
• chronic obstructive pulmonary disease
• exacerbation
• FEV₁ decline
• inhaled corticosteroid

Data Sharing Statement

Data underlying the findings described in this manuscript may be obtained in accordance with AstraZeneca’s data sharing policy described at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Compliance with Ethics Guidelines

This study was conducted following the Declaration of Helsinki and all applicable national and international ethical guidelines for medical and health research involving human participants. The Ethics Committee of Tohoku University Hospital (approval reference: 2018-2-147-1) approved all study documentation. All participants gave informed consent before registration. Medical data were collected and stored in compliance with the relevant laws/regulations concerning data protection and the Personal Information Protection Act. This study was registered with ClinicalTrials.gov (identifier: NCT03577795).

Acknowledgments

The authors would like to thank the participants in the ACO Japan study. The authors also wish to thank Keyra Martinez Dunn, MD of Edanz, Japan, for providing medical writing support, which was funded by AstraZeneca K.K., Japan, through EMC K.K., Japan, in accordance with Good Publication Practice 2022 guidelines (https://www.ismpp.org/gpp-2022).

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; and took part in drafting, revising, or critically reviewing the article. All authors, except for Shu Hashimoto who passed away before the manuscript draft was finalized, gave approval for the final version to be published, and hold accountability for the accuracy and integrity of the findings presented.

Disclosure

Yuri Yoshida, Naoyuki Makita, Ryoko Sorimachi, Satoko Sugaya, Yoshifumi Arita, Nobuya Hayashi, and Naoki Tashiro are employees of AstraZeneca K.K. Shu Hashimoto and Masakazu Ichinose have no conflicts of interest to declare in this work.

Additional information

Funding

This research was funded by AstraZeneca K.K., Osaka, Japan, in accordance with Good Publication Practice guidelines.