chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
None listed
Sponsors
Tohoku University
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the frequency of moderate to severe exacerbations (annual exacerbation rate) over a 3-year period in patients with COPD who have been receiving optimal inhaled therapy (ICS/LAMA/LABA triple therapy or LAMA/LABA dual therapy) for 6 months or more. Rationale for Primary Endpoint Selection: - Clinical Significance: COPD exacerbations represent the most critical outcome with substantial impact on patient prognosis, quality of life, and healthcare economics. Moderate to severe exacerbations (requiring systemic corticosteroids or antibiotics, or hospitalization) are well-established to be strongly associated with irreversible decline in lung function, increased cardiovascular event risk, and elevated mortality. - Scientific Validity: Exacerbation frequency has been adopted as a standard primary endpoint in large-scale clinical trials (IMPACT, ETHOS, KRONOS trials, etc.) and represents the international gold standard for treatment efficacy assessment. - Measurability: Exacerbation definition and severity grading are clearly established (administration of systemic corticosteroids or antibiotics, hospitalization) and can be objectively evaluated. - Assessment Timeline: Baseline evaluation: At enrollment Regular assessments: Evaluation of exacerbations occurring in the previous 12 months at 1-year, 2-year, and 3-year timepoints (recording date of occurrence, severity, treatment details, and outcomes) - Analysis Timeline: Calculated as annual exacerbation rate following completion of the 3-year observation period | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Exacerbation-Related Endpoints Exacerbation severity distribution: Proportions of mild, moderate, and severe exacerbations Assessment timing: At time of exacerbation occurrence and during annual evaluations Time to first exacerbation: Number of days from enrollment to first moderate or severe exacerbation Exacerbation-related hospitalization rate: Annual hospitalization rate and length of hospital stay Recovery period after exacerbation: Number of days from exacerbation onset to symptom stabilization (2) Pulmonary Function Endpoints Change in post-bronchodilator FEV1: Absolute change from baseline (mL) and percentage change (%) Assessment timing: At enrollment, 1 year, 2 years, and 3 years Annual FEV1 decline rate: Calculated from longitudinal FEV1 changes over 3 years (mL/year) Change in FVC: Change from baseline (3) Patient-Reported Outcomes (PRO) Change in CAT (COPD Assessment Test) score Assessment timing: At enrollment, 1 year, 2 years, and 3 years Minimal clinically important difference (MCID): Change of > or = 2 points Change in mMRC (modified Medical Research Council) dyspnea scale Assessment timing: Same as above MCID: Change of > or =1 grade | — |
Countries
Japan
Contacts
Public ContactNaoya Fujino
Tohoku University Hospital Department of Respiratory Medicine
Outcome results
None listed