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.

A Non-Interventional, Cross-Sectional Study to Evaluate Factors Relating to Daily Step Counts and Physical Activity in Japanese Patients with Chronic Obstructive Pulmonary Disease: STEP COPD.

Purpose: Patients with chronic obstructive pulmonary disease (COPD) have decreased physical activity (PA) compared with healthy adults. As lower PA is associated with increased mortality, improving PA is an important objective for COPD management. This large-scale, multicenter, non-interventional, cross-sectional study examined the activity status of COPD patients in Japan and explored factors related to PA. Patients and Methods: Outpatients aged ≥40 years with confirmed COPD diagnosis and pulmonary function test data were enrolled. Primary study outcomes were measurement of daily steps (over 14 consecutive days, using an activity monitor), assessment of activity time by activity intensity (using metabolic equivalents [METs]), and evaluation of correlation between PA and patient characteristics. Secondary outcomes included further investigation of the influence of patient characteristics on PA. Results: Data from 417 patients with Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages I (29.5%), II (43.9%), III (23.5%), and IV (3.1%) were evaluated. Median (Q1, Q3) daily step count was 3440.8 (1831.3, 5709.3). Median (Q1, Q3) durations of PA at ≥3 (moderate-to-vigorous) and ≥2 METs (light-to-vigorous) were 18.7 (6.5, 41.3) and 186.9 (126.9, 259.2) minutes, respectively. For >30% of patients, time spent in ≥3 METs activity was ≤10 minutes. Unemployment was significantly correlated with reduced activity time (≥3 and ≥2 METs) and step count. Severe GOLD stage was significantly correlated with reduced activity time (≥3 and ≥2 METs). High modified Medical Research Council (mMRC) dyspnea score was significantly correlated with reduced activity time (≥3 METs) and step count. Patients tended to overestimate the time spent in activities requiring ≥2 METs in their subjective reports compared with activity monitor measurements. Conclusion: Reduced PA was observed in the Japanese COPD patients with the majority of them being GOLD stage I/II. Employment status, GOLD stage, and mMRC dyspnea score could help identify patients at risk of reduced PA. Clinical Trial Registration: NCT03642613 (ClinicalTrials.gov); UMIN000032962 (UMIN-CTR, umin.ac.jp).

Efficacy and safety of topical OPA-15406, a new phosphodiesterase 4 inhibitor, in Japanese patients with atopic dermatitis for 8 weeks: A phase 2, randomized, double-blind, placebo-controlled study.

The efficacy and safety of topical OPA-15406, a new phosphodiesterase 4 inhibitor, were examined in Japanese patients aged 15-70 years with atopic dermatitis in a phase 2, randomized, double-blind, vehicle-controlled study. Two hundred patients were randomized to three treatment groups at a 1:1:1 ratio to receive OPA-15406 0.3%, OPA-15406 1% or vehicle ointment twice daily for 8 weeks. The OPA-15406 1% group was superior to the vehicle group in terms of the incidence of success based on the Investigator Global Assessment score at week 4 (P = 0.0328), which was the primary end-point, while the OPA-15406 0.3% group showed a trend toward improvement in the primary end-point. The mean Eczema Area and Severity Index total score and subscale (erythema, induration/papulation, excoriation and lichenification) scores, the Visual Analog Scale pruritus score and the Patient-Oriented Eczema Measure score were significantly improved and the percentage of affected body surface area was significantly decreased in both OPA-15406 groups relative to the vehicle group as early as week 1, and the improved scores and decreased percentages were generally maintained until week 8. No deaths or serious treatment-emergent adverse events occurred in the OPA-15406 treatment groups. Treatment-emergent adverse events frequently observed across treatment groups were worsening of atopic dermatitis, viral upper respiratory tract infection and pruritus, all of which were mild or moderate in severity in the OPA-15406 groups. OPA-15406 1% ointment showed favorable efficacy and safety profiles, indicating a promising treatment option for patients with atopic dermatitis.