REALizing and improving management of stable COPD in China: a multi-center, prospective, observational study to realize the current situation of COPD patients in China (REAL) – rationale, study design, and protocol

Table 2 Endpoints of REAL

Endpoints	Outcome measures
Primary	Mean rate of acute exacerbations (per patient per year)^a Proportion of patients hospitalized due to exacerbation^a Distribution of COPD exacerbations by severity Mean reduction from baseline of available FEV₁^a Mean change in CAT total score Mean change in mMRC score Mean change in COPD-Q total score
Secondary	Distribution of disease severity at baseline and V1 Distribution of COPD medication by drug class^b at baseline and V1 Distribution of maintenance medication^a and dosage by disease severity at baseline and V1 Distribution of maintenance medication^b at each usual visit Distribution of medications for exacerbations Distribution of non-drug treatments (health education, smoking cessation, physical activity, and vaccination) Medication compliance Visit compliance Mean total direct cost of COPD management over 1 year
Exploratory	Risk factors for exacerbations Risk factors for disease severity Risk factors for medication compliance

^a Also stratified by disease severity at baseline
^bICS Inhaled corticosteroid, LABA long-acting β₂-agonist, ICS/LABA combined long-acting β₂-agonists plus corticosteroid, SABA short-acting β₂-agonist, SAMA short-acting muscarinic antagonist, SABA/SAMA combined short-acting β₂-agonist plus short-acting muscarinic antagonist, LAMA long-acting muscarinic antagonist, methylxanthines, mucolytics, traditional Chinese medicine, and others (antibiotics, systemic corticosteroids, vaccines, antioxidant agents, etc.)

ISSN: 1471-2466