Evaluation of Changes in Control Status in COPD: An Opportunity for Early Intervention.

BACKGROUND: Control has been proposed as a dynamic tool that can capture changes in the clinical status of patients with COPD. METHODS: This prospective, multicenter, observational study aimed to compare changes in control over a 3-month period with changes in risk level, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage, and clinical phenotype (nonexacerbator, asthma-COPD overlap, or exacerbator with emphysema or with chronic bronchitis). Control was defined as the presence of low clinical impact, assessed according to the degree of dyspnea, use of rescue medication, physical activity and sputum color, and clinical stability assessed by clinical changes and exacerbations in the last 3 months. Impact and stability were alternatively assessed with COPD Assessment Test (CAT) scores. RESULTS: We included 354 patients, with a mean FEV1 of 49.8% ± 16.9%. At 3 months, the proportion of controlled patients was 50.3% according to clinical evaluation and 47.8% according to CAT score. Eighty-seven patients (29.2%) changed their control status as assessed by clinical variables, and 85 patients (28.5%) changed their status according to CAT score. In contrast, the risk level only changed in 26 patients (8.7%) (P < .001), 27 patients (9.1%) experienced changes in their clinical phenotype (P < .001), and 59 patients (19.8%) experienced changes in their GOLD stage (P = .008). Patients who showed an improvement in control status had better CAT scores at the end of follow-up (P < .001). CONCLUSIONS: In only 3 months, almost one-third of patients experienced changes in their control status. Changes in control status were significantly more frequent than changes in phenotype, risk level, and GOLD stage, and resulted in significant changes in health status.

Validation of clinical control in COPD as a new tool for optimizing treatment.

BACKGROUND: It has recently been proposed that the concept of clinical control in COPD may be useful for deciding treatment in COPD, but the original control criteria (OCC) were considered too restrictive. OBJECTIVE: Define and subsequently validate "modified" control criteria (MCC) of COPD. METHOD: Prospective observational study in COPD patients with a 1-year follow-up. Control was defined as the presence of low clinical impact and clinical stability. To evaluate clinical impact, the following clinical parameters were assessed: the degree of dyspnea, use of rescue medication, physical activity, and sputum color. Stability was assessed by clinical changes and exacerbations in the last 3 months. The COPD assessment test score and their changes were also evaluated as alternative control criteria. To define the MCC, adjustment for disease severity using BODEx index (MCC-B) or FEV1 (MCC-F) was evaluated, and the best cutoff point was established. Time to first combined event (emergency visit, hospitalization, or death) was analyzed to evaluate the predictive capacity of risk of the OCC, MCC-B, and MCC-F. RESULTS: We included 265 patients, 224 (83.9%) men, with a mean age (±SD) of 68±9 years and FEV1 of 58%±17%. The proportion of controlled patients was higher using clinical MCC-B or MCC-F (61.5% and 59.6%) than OCC (27.5%). Similar percentages were found using COPD assessment test scores. The time to the first combined event was significantly greater in controlled patients using MCC criteria (P<0.001, all cases). The predictive capacity of risk was similar in MCC-B (c-statistic [C]=0.639) and MCC-F (C=0.637) and higher than OCC (C=0.589). CONCLUSIONS: The new MCC identified a higher number of controlled COPD patients. These patients have a better quality of life and lower risk of poor outcomes. The concept of control and the new MCC could be a useful tool to optimize therapy.