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Juan José Soler-Cataluña,1,2 Arturo Huerta,3 Pere Almagro,4 Diego González-Segura,5 Borja G Cosío6 On behalf of the CLAVE Study Investigators1Department of Pneumology, Hospital Arnau de Vilanova-Lliria, Valencia, Spain; 2Medicine Department, València University and CIBERES, Valencia, Spain; 3Pulmonary and Critical Care Division, Clínica Sagrada Família, Barcelona, Spain; 4Internal Medicine Department, Mutua Terrassa University Hospital, Terrassa, Spain; 5Medical Advisor, Chiesi SAU, Barcelona, Spain; 6Department of Pneumology, H. Universitari Son Espases Hospital-IdISBa and CIBERES, Palma de Mallorca, SpainCorrespondence: Juan José Soler-Cataluña, Department of Pneumology Arnau de Vilanova-Lliria, C/San Clemente 12, Valencia, 46015, Spain, Email jjsoler@telefonica.netIntroduction: According to the Global Initiative for chronic obstructive lung disease (GOLD), when a treatment is not achieving an appropriate response it should be switched taking into account the predominant treatable trait to target (dyspnea or exacerbations). The objective of the present study was to investigate the lack of clinical control according to the target and medication groups.Materials and Methods: This was a post-hoc analysis of the CLAVE study, an observational, cross-sectional, multicenter study which evaluated the clinical control, and related-factors, in a cohort of 4801 patients with severe chronic obstructive pulmonary disease (COPD). The primary endpoint was the percentage of uncontrolled patients defined as COPD Assessment Test (CAT) > 16 or presence of exacerbations in the last 3 months despite receiving long-acting beta2-agonist (LABA) and/or long-acting antimuscarinic antagonist (LAMA) with or without inhaled corticosteroids (ICS). Secondary objectives included the description of sociodemographic and clinical characteristics of patients by therapeutic group and the identification of characteristics potentially associated with the lack of control of COPD including low adherence measured by the test to adherence to inhalers (TAI).Results: In the dyspnea pathway, lack of clinical control was of 25.0% of patients receiving LABA or LAMA in monotherapy, 29.5% by those with LABA + LAMA, 38.3% with LABA + ICS and 37.0% with triple therapy (LABA + LAMA + ICS). In the exacerbation pathway, percentages were 87.1%, 76.7%, 83.3%, and 84.1%, respectively. Low physical activity and high Charlson comorbidity index were independent factor of non-control in all therapeutic groups. Additional factors were lower post-bronchodilator FEV1 and poor adherence to inhalers.Conclusion: There are still room for improvement in COPD control. From the pharmacological perspective, every step in treatment have a pool of uncontrolled patients in which a step-up could be considered according to a trait to target strategy.Keywords: COPD, control, target, dyspnea, comorbidities, treatment

Juan José Soler-Cataluña,1 Pere Almagro,2 Arturo Huerta,3 Diego González-Segura,4 Borja G Cosío5 On behalf of the CLAVE study Investigators1Department of Pneumology, Hospital Universitari Arnau de Vilanova and CIBERES, Valencia, Spain; 2Multimorbidity Patients Unit. Internal Medicine Department, H. Mutua Terrassa University Hospital, Terrassa, Barcelona, Spain; 3Emergency Department – Medicine and Pulmonary Section, H. Clínic de Barcelona, Barcelona, Spain; 4Medical Department, Chiesi SAU, Barcelona, Spain; 5Department of Pneumology, H. Universitari Son Espases Hospital-IdISBa and CIBERES, Palma de Mallorca, Balearic Islands, SpainCorrespondence: Juan José Soler-CataluñaDepartment of Pneumology, H. Universitari Arnau de Vilanova, C/San Clemente 12, Valencia 46015, SpainTel + 973 24 81 00Email jjsoler@telefonica.netBackground: Clinical control in chronic obstructive pulmonary disease (COPD) has not been completely characterized. A proposal of clinical control criteria (CCC) has been recently defined and validated as a tool for determining control, but there is scarce information on patients with severe COPD.Objective: To evaluate clinical control in severe COPD using the CCC.Patients and Methods: The study design was observational, multicenter, cross-sectional study involving 4801 patients with severe COPD in Spain. Clinical control was defined according to clinical impact (dyspnea grade, use of rescue treatment in last week, sputum color, and daily physical activity) and stability (exacerbations in last 3 months and patient’s perception about health status). Clinical control of COPD was alternatively evaluated with the COPD assessment test (CAT) and the presence of exacerbations in the last 3 months.Results: According to CCC, 61.0% of patients had low clinical impact, and 41.4% showed clinical stability. Overall, 29.9% of patients had both low clinical impact and stability (controlled), whereas 70.1% showed high clinical impact and/or no clinical stability (non-controlled). COPD control was also assessed by using only the definition of CAT≤ 16 and no exacerbations in the last 3 months. Results obtained with this definition were similar to those obtained by CCC, and the concordance between both definitions was high (Kappa index = 0.698).Conclusion: By using the CCC, approximately only one third of patients with severe COPD were considered as controlled. Physical activity, adherence to inhalers, age, post-bronchodilator FEV1, age-adjusted Charlson comorbidity index, and healthcare level were independent factors associated with COPD control.Keywords: COPD, control, clinical, exacerbations, criteria, CAT