Tokyo, March 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059413) titled 'Japanese Multicenter Study for Identifying Unmet Needs in COPD Patients' on March 1.

Study Type: Observational

Primary Sponsor: Institute - Tohoku University

Condition: Condition - chronic obstructive pulmonary disease (COPD) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Patients with chronic obstructive pulmonary disease (COPD) who have been receiving guideline-based optimal inhaled therapy for more than 6 months will be prospectively observed for 3 years, with exacerbation frequency as the primary endpoint and the following as secondary endpoints: severity of exacerbations that occur, changes in post-bronchodilator forced expiratory volume in one second (FEV1), changes in symptom questionnaire scores, occurrence and nature of cardiovascular events, COPD medication changes, changes in imaging findings, progression to frailty and pre-frailty, and disease stability. Through comparison between patients with and without exacerbations over the 3-year period, we will elucidate the demographic characteristics (age, sex, body mass index [BMI], smoking history), clinical characteristics (COPD severity, comorbidities, IgE, peripheral blood eosinophil count, fractional exhaled nitric oxide [FeNO], pulmonary function tests, COPD Assessment Test [CAT] score, modified Medical Research Council Dyspnea Scale [mMRC], number of exacerbations [in the year prior to enrollment], etc.), and molecular pathological features (transcriptomic and proteomic analyses of sputum and peripheral blood mononuclear cells) at enrollment in patients who experience exacerbations. This study aims to identify unmet medical needs in COPD patients continuing optimal inhaled therapy and to clarify their clinical and molecular pathological characteristics. Basic objectives2 - Others

Eligibility: Age-lower limit - 40 years-old

Gender - Male and Female Key inclusion criteria - (1) Disease: Chronic obstructive pulmonary disease (COPD) and non-COPD patients. COPD diagnosis follows the current Guidelines for the Diagnosis and Treatment of COPD 2022 (Japanese Respiratory Society). COPD diagnostic criteria require post-bronchodilator spirometry showing FEV1/FVC < 0.70, presence of exposure factors such as long-term smoking history, and exclusion of other diseases that may cause airflow obstruction.

(2) Disease stage, severity, and diagnostic criteria COPD patients meeting all of the following conditions: Post-bronchodilator spirometry showing FEV1/FVC < 0.70

(3) Age: 40 years or older and 85 years or younger (at enrollment)

(4) Sex: Both male and female patients are eligible for both COPD and non-COPD groups

(5) Smoking history: Regarding smoking as a major risk factor for COPD, 10 pack-years (daily cigarettes/20 x years of smoking) or more is the standard criterion in clinical research, therefore smoking history is defined as having 10 pack-years or more of smoking. Those with smoking history are either currently smoking (current smokers) or have a history of past smoking (former smokers). COPD patients with smoking history are eligible.

(6) Treatment history: Stable patients who have been continuing triple therapy (ICS/LAMA/LABA), LABA/LAMA dual therapy, or monotherapy such as LABA alone or LAMA alone for at least 6 months. At least 6 months of continuation from treatment initiation is required to adequately evaluate the effects of optimal inhaled therapy.

(7) Definition of exacerbation Exacerbation is defined as worsening of respiratory symptoms (dyspnea, cough, sputum) requiring additional treatment beyond usual maintenance therapy.

(8) Definition of stable state Patients with no occurrence of COPD exacerbation within 4 weeks prior to study enrollment

(9) Individuals from whom written informed consent for study participation has been obtained Key exclusion criteria - (1) Asthma: Cases with asthma as the primary diagnosis are excluded (however, asthma-COPD overlap is not an exclusion criterion and will be included as a subgroup for analysis)

(2) Individuals with other clinically significant pulmonary diseases (diffuse lung disease [however, combined pulmonary fibrosis and emphysema may be included if obstructive ventilatory impairment is present], active respiratory infections, etc.)

(3) Individuals who experienced COPD exacerbation within 4 weeks prior to study enrollment and received treatment with systemic corticosteroids and/or antibiotics

(4) Individuals who suffered from active infections or cardiovascular disease events within 4 weeks prior to study enrollment

(5) Individuals with dementia or psychiatric disorders that prevent completion of self-administered questionnaires

(6) Individuals who are pregnant or possibly pregnant, breastfeeding, or planning pregnancy during the study participation period Target Size - 500

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 20 Day Anticipated trial start date - 2026 Year 01 Month 01 Day Last follow-up date - 2030 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067915

Disclaimer: Curated by HT Syndication.