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

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.

Real-World Status of Medical Care and Treatment of Chronic Obstructive Pulmonary Disease by Respiratory Specialists in Japan.

INTRODUCTION: The ACO Registry Study was a multicenter, prospective, observational cohort study aiming to clarify the situation of asthma-chronic obstructive pulmonary disease (COPD) overlap (ACO) within the COPD population using the Japanese Respiratory Society (JRS) criteria. We reported the proportion of patients who met the ACO criteria among the COPD population at study registration. METHODS: Using data collected at registration, we investigated the implementation of each diagnostic examination/test required for ACO diagnosis in the full analysis set. Among patients with data necessary for ACO diagnosis, ACO/non-ACO patients with/without asthma diagnosed by a physician and proportions of inhaled corticosteroid (ICS) treatments for COPD were calculated. RESULTS: Of 708 patients analyzed, 396 (55.9%) had the data necessary for ACO diagnosis, and 312 (44.1%) did not. The proportions of patients who underwent laboratory and respiratory function tests (peripheral blood eosinophil count [79.8%], fractional exhaled nitric oxide [63.7%], airway reversibility [46.8%], and total immunoglobulin [Ig] E/specific IgE [33.3%]) were lower than those who underwent subjective examinations (perennial allergic rhinitis [100%], asthma before age 40 years [97.2%], and variable/paroxysmal respiratory symptoms [94.5%]). Among patients with the data necessary for ACO diagnosis and without asthma complications according to the physician's diagnosis, 15.1% (33/219) met the ACO criteria. Of patients who met the ACO criteria, 74.3% (75/101) received ICS, and 25.7% (26/101) did not. By comparison, among patients who did not meet the ACO criteria, 35.6% (105/295) were receiving ICS, and 64.4% (190/295) were not. CONCLUSIONS: The proportion of objective laboratory and physiological tests was lower than expected, despite study sites having the clinical resources for objective tests. Most ACO patients were being treated with ICS as recommended in the JRS treatment guidelines. Attempts should be made to further increase the proper use of ICS among these patients in Japan. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03577795.

Asthma and Chronic Obstructive Pulmonary Disease Overlap According to the Japanese Respiratory Society Diagnostic Criteria: The Prospective, Observational ACO Japan Cohort Study.

INTRODUCTION: Patients with asthma-chronic obstructive pulmonary disease (COPD) overlap (ACO) present with chronic respiratory symptoms with features of both asthma and COPD. New ACO diagnostic criteria (2018) were suggested by the Japanese Respiratory Society (JRS). This prospective, multicenter, observational cohort study was conducted to investigate the proportion of patients who meet the JRS ACO diagnostic criteria among COPD patients in clinical practice. METHODS: This 2-year ongoing study enrolled consecutive outpatients aged ≥ 40 years with COPD who visited one of 27 Japanese centers at which the medical examinations/tests required for ACO diagnosis were routinely conducted. At registration, the proportion of ACO or non-ACO patients was determined using the JRS diagnostic criteria, and the characteristics of the two groups were compared using analysis of variance and chi-square test. RESULTS: Of 708 COPD patients analyzed at registration, 396 (55.9%) had the data necessary for ACO diagnosis to be conducted, and 312 (44.1%) were lacking these data. Of the 396 patients who had the data necessary for ACO diagnosis, 101 (25.5%) met the diagnostic criteria for ACO, and 295 (74.5%) did not (non-ACO patients). ACO patients were younger, had a greater rate of asthma based on a physician's diagnosis, and used more medications, including inhaled corticosteroids (p < 0.05), compared with non-ACO patients. CONCLUSIONS: We have determined the proportion of patients with the data necessary to diagnose ACO using the JRS criteria, and the proportion of these who met the ACO criteria among the COPD population at the time of registration. Patients, including those lacking necessary examination/test data at registration, will continue to undergo follow-up to explore changes in their testing and ACO diagnostic status over time. Analyses of study data over 2 years will provide relevant information on the ACO symptoms, clinical course, and real-world treatment patterns. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03577795.