Search

Alexa Núñez,1 Cristina Esquinas,1 Miriam Barrecheguren,1 Myriam Calle,2,3 Ricard Casamor,4 Marc Miravitlles1,5 1Pneumology Department, Hospital Universitari Vall d’Hebron/Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain; 2Pneumology Department, Hospital Clínico de San Carlos, Madrid, Spain; 3Departamento de Medicina, Facultad de Medicina, Universidad Complutense de Madrid, Madrid, Spain; 4Medical Department, Novartis Farmaceutica, Barcelona, Spain; 5CIBER de Enfermedades Respiratorias (CIBERES), Barcelona, Spain Purpose: The aim of this study was to evaluate the impact of morning symptoms in COPD using the Capacity of Daily Living during the Morning (CDLM) questionnaire and to determine the clinical variables that are related to CDLM scores.Methods: This was an observational, cross-sectional, and multicenter study conducted in stable COPD patients. CDLM scores ranged from 0 to 5 and were transformed into a qualitative variable according to tertile values to compare patient characteristics. A multivariate linear regression model was used to identify the clinical variables related to CDLM scores.Results: A total of 605 patients were included in the study; the mean age (SD) was 68 years (9.1) and mostly were male (80.8%). The mean post-bronchodilator FEV1% was 53.4% (19.2%), and the mean BODEx (body mass index, airway obstruction, dyspnea, exacerbation) score was 3.2 (2.0). The mean COPD assessment test (CAT) score was 16.6 (8.3), and the mean CDLM score was 4.2 (0.9). First tertile patients, that is, those with a higher impact in the morning, were older, had more respiratory symptoms, more dyspnea, a lower FEV1%, lower CAT and BODEx scores, and more exacerbations. We found a ceiling effect on the CDLM scores: 194 (32%) patients scored 5.00 and no patients scored 0. On multivariate analysis, higher CAT and BODEx scores, a lower FEV1%, and use of long-term oxygen therapy (LTOT) were all independently related to lower CDLM scores.Conclusion: Morning respiratory symptoms are associated with more severe airflow obstruction, lower CAT and BODEx scores, and LTOT. The ceiling effect of the CDLM questionnaire does not allow it to discriminate well between low and high impact of morning symptoms. Keywords: health-related quality of life, COPD, morning symptoms questionnaire, CAT

Myriam Calle Rubio,1,2 Ricard Casamor,3 Marc Miravitlles4 On behalf of the FENEPOC study group1Pulmonary Department, Hospital Clínico San Carlos, 2Department of Medicine, Faculty of Medicine, University Complutense of Madrid, Research Institute of Hospital Clínico San Carlos (IdISSC), Madrid, 3Medical Department, Novartis Farmaceutica, Barcelona, 4Pneumology Department, University Hospital Vall d’Hebron, CIBER de Enfermedades Respiratorias (CIBERES), Barcelona, SpainBackground: The Spanish Guidelines for COPD (GesEPOC) describe four clinical phenotypes: non-exacerbator (NE), asthma-COPD overlap syndrome (ACO), frequent exacerbator with emphysema (EE), and exacerbator with chronic bronchitis (ECB). The objective of this study was to determine the frequency of COPD phenotypes, their clinical characteristics, and the availability of diagnostic tools to classify COPD phenotypes in clinical practice.Materials and methods: This study was an epidemiological, cross-sectional, and multicentered study. Patients ≥40 years old with a post-bronchodilator forced expiratory volume in 1 s (FEV1)/forced vital capacity ratio of 80% of the diagnostic tools needed to classify COPD phenotypes were available, with the exception of computed tomography (26.9%) and carbon monoxide transfer test (13.5%) in PC, and sputum eosinophilia count in PC and pulmonology centers (40.4% and 49.4%, respectively).Conclusion: In Spanish clinical practice, almost half of the patients with COPD presented with NE phenotype. The prevalence of ACO according to the Spanish consensus definition was very low. In general, physicians indicated that they had the necessary tools for diagnosing COPD phenotypes.Keywords: chronic obstructive pulmonary disease, phenotype, diagnosis, emphysema, chronic bronchitis, ACO

Jose M Marin,1 Kai M Beeh,2 Andreas Clemens,3 Walter Castellani,4 Lennart Schaper,5 Dinesh Saralaya,6 Anthony Gunstone,7 Ricard Casamor,8 Konstantinos Kostikas,3 Maryam Aalamian-Mattheis3 1University Hospital Miguel Servet, IISAragón, CIBERES, Zaragoza, Spain; 2Insaf Respiratory Research Institute, Wiesbaden, Germany; 3Novartis Pharma AG, Basel, Switzerland; 4Hospital Piero Palagi, Fiorenze, Italy; 5Research Institute and Practice, Berlin-Brandenburg, Germany; 6Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK; 7Staploe Medical Center, Soham, Cambridge, UK; 8Novartis Farmaceutica SA, Barcelona, Spain Background: Morning symptoms associated with COPD have a negative impact on patients’ quality of life. Long-acting bronchodilators with rapid onset may relieve patients’ symptoms. In the Symptoms and Pulmonary function in the moRnING study, we prospectively compared the rapid onset bronchodilator profile of glycopyrronium (GLY) and tiotropium (TIO) during the first few hours after dosing in patients with moderate-to-severe COPD.Methods: Patients were randomized (1:1) to receive either once-daily GLY (50 µg) or TIO (18 µg) and corresponding placebos in a cross-over design for 28 days. The primary objective was to demonstrate the superiority of GLY versus TIO in area under the curve from 0 to 4 hours (AUC0-4h) forced expiratory volume in 1 second (FEV1) after the first dose. The secondary objective was to compare GLY versus TIO using the patient reported outcomes Morning COPD Symptoms Questionnaire 3 hours post-inhalation.Results: One-hundred and twenty-six patients were randomized (male 70.2%; mean age 65.7 years) and 108 patients completed the study. On Day 1, GLY resulted in significantly higher FEV1 AUC0-4h after the first dose versus TIO (treatment difference [Δ], 0.030 L, 95% confidence interval 0.004–0.056, P=0.025). Improvements in morning COPD symptoms from baseline at Days 1 and 28 were similar between GLY and TIO. Post hoc analysis of the FEV1 AUC0-4h by time point on Day 1 showed significant improvements in patients receiving GLY versus TIO at 5 minutes (Δ=0.029 L, P=0.015), 15 minutes (Δ=0.033 L, P=0.026), and 1 hour (Δ=0.044 L, P=0.014). Safety results were comparable between both treatments.Conclusion: The SPRING study demonstrates the superiority of GLY versus TIO in terms of superior bronchodilation in the first 4 hours after administration, thus extending the clinical data that support a faster onset of action of GLY versus TIO. Keywords: LAMA, glycopyrronium, tiotropium, lung function, fast onset, rapid onset, patient reported outcome, COPD

Pedro J Marcos,1 Rosa Malo de Molina,2 Ricard Casamor3 1Servicio de Neumología, Instituto de investigación Biomédica de A Coruña (INIBIC), Complejo Hospitalario Universitario de A Coruña (CHUAC), Sergas Universidade da Coruña (UDC), A Coruña, 2Servicio de Neumología, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, 3Medical Department, Novartis Farmacéutica SA, Barcelona, Spain Background: The aim of this study was to identify the percentage of undiagnosed patients with COPD through the implementation of an active search strategy in a selected subject population. Methods: An observational, cross-sectional, multicenter study was conducted in a primary care setting in Spain. General practitioners gave their diagnostic impression of COPD (yes/no) on the basis of clinical criteria of subjects with respiratory symptoms and tobacco exposure. Subsequently, post-bronchodilator spirometry and quality-of-life tests were performed. Multivariate logistic regression techniques using receiver operating characteristic (ROC) curves were used to identify the combination of variables that best discriminates COPD. Results: A total of 2,758 patients were screened at 368 primary care centers, of which 1,725 patients were included in the study. Seven hundred and ninety-three patients (46%) were diagnosed with COPD. Clinical judgment resulted in suspected COPD in 1,393 (81%) of the subjects. The best variables to discriminate COPD were a history of lower respiratory tract infections, cough, and dyspnea. This combination identified COPD with a ROCAUC of 0.61 denoting a poor discriminative ability. Conclusion: Employing an active search strategy leads to a new COPD diagnosis in almost half of the subjects. Screening of COPD with post-bronchodilator spirometry should be considered mandatory for any high-risk subject visiting the general practitioner clinic for any reason. Keywords: COPD, post-bronchodilator spirometry, primary care, screening

Alberto Fernández-Villar,1 José Luis López-Campos,2,3 Cristina Represas Represas,1 Lucía Marín Barrera,3 Virginia Leiro Fernández,1 Cecilia López Ramírez,3 Ricard Casamor4 1Department of Pneumology, Complexo Hospitalario de Vigo, Instituto de Investigación Biomédica de Vigo, Vigo, 2Medical-Surgical Unit of Respiratory Diseases, Instituto de Biomedicina de Sevilla, Hospital Universitario Virgen del Rocío/Universidad de Sevilla, Seville, 3Centro de Investigación Biomédica en Red de Respiratorio, Instituto de Salud Carlos III, Madrid, 4Medical Department, Novartis Farmacéutica, Barcelona, Spain Background: The purpose of this study was to evaluate the frequency of inadequate diagnosis and factors predictive of this in patients with chronic obstructive pulmonary disease (COPD) participating in the On-Sint study. Methods: The On-Sint cohort was recruited for a multicenter observational study in which 356 physicians (71.6% from primary care) included adult patients who had been diagnosed with COPD. Patients’ clinical and functional information since diagnosis and details for the recruiting physicians were collected from patient files and at the inclusion visit. We performed a multivariate analysis to evaluate the influence of these variables on diagnostic inadequacy (absence of postbronchodilator forced expiratory volume in one second/forced vital capacity [FEV1/FVC]

Jose Luis Lopez-Campos,1,2,* Alberto Fernandez-Villar,3,* Carmen Calero-Acuña,1 Cristina Represas-Represas,3 Cecilia Lopez-Ramírez,1 Virginia Leiro Fernández,3 Juan Jose Soler-Cataluña,2,4 Ricard Casamor5 On behalf of the On-Sint study group 1Unidad Médico-Quirúrgica de Enfermedades Respiratorias, Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocio/Universidad de Sevilla, Sevilla, Spain; 2CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain; 3Servicio de Neumología, Instituto de Investigación Biomédica de Vigo (IBIV), Complexo Hospitalario de Vigo, Vigo, Spain; 4Servicio de Neumología Hospital Arnau de Vilanova, Valencia, Spain; 5Departamento Médico de Novartis Farmacéutica, Barcelona, Spain *These authors contributed equally to this work Background: The COPD Assessment Test (CAT) has been recently developed to quantify COPD impact in routine practice. However, no relationship with other measures in the Global Initiative for Obstructive Lung Disease (GOLD) strategy has been evaluated. The present study aimed to evaluate the relationship of the CAT with other GOLD multidimensional axes, patient types, and the number of comorbidities.Methods: This was a cross-sectional analysis of the Clinical presentation, diagnosis, and course of chronic obstructive pulmonary disease (On-Sint) study. The CAT score was administered to all participants at the inclusion visit. A GOLD 2011 strategy consisting of modified Medical Research Council scale (MRC) scores was devised to study the relationship between the CAT, and GOLD 2011 axes and patient types. The relationship with comorbidities was assessed using the Charlson comorbidity index, grouped as zero, one to two, and three or more.Results: The CAT questionnaire was completed by 1,212 patients with COPD. The CAT maintained a relationship with all the three axes, with a ceiling effect for dyspnea and no distinction between mild and moderate functional impairment. The CAT score increased across GOLD 2011 patient types A–D, with similar scores for types B and C. Within each GOLD 2011 patient type, there was a considerably wide distribution of CAT values.Conclusion: Our study indicates a correlation between CAT and the GOLD 2011 classification axes as well as the number of comorbidities. The CAT score can help clinicians, as a complementary tool to evaluate patients with COPD within the different GOLD patient types. Keywords: chronic obstructive pulmonary diseases, multidimensional evaluation, comorbidities

Background: Disease control is an important objective of COPD management. The SINCON study evaluated the level of control in terms of respiratory symptoms and exacerbations in Spanish patients with COPD for ≥2 years., Methods: SINCON was a descriptive, cross-sectional, multicenter study that assessed degree of control using a combined index comprising COPD assessment test (CAT), modified Medical Research Council dyspnea scale (mMRC), and number of moderate/severe exacerbations in the last year. Based on this score, patients were categorized as "well controlled" or "poorly controlled". Degree of control was also assessed relative to patient phenotype, setting (primary care [PC] vs respiratory care [RC]), and impact of treatment on morning symptoms., Results: Of the 481 patients (PC: 307, RC: 174) analyzed, COPD was poorly controlled in 63.2%. Some differences were found between clinical settings: PC patients were more poorly controlled (PC: 66.4% vs RC: 57.5%; P = 0.06) and had higher CAT score (PC: 17.9 vs RC: 15.5; P < 0.05), and higher rate of moderate/severe exacerbations during previous year (PC: 1.5 vs RC: 1.1; P < 0.05), while dyspnea degree was similar in both settings. Regarding phenotypes, non-exacerbators demonstrated better control vs exacerbators. Morning symptoms score improved between waking and 3 h after bronchodilator treatment (P < 0.05), with greater improvements in PC patients (PC: - 6.5 vs RC: - 5.0 points; P < 0.05)., Conclusions: Most COPD patients were poorly controlled with some differences observed between PC and RC settings and between patient phenotypes. Our index may be easily used in PC settings to optimize COPD treatment.

Background : COPD is a chronic disease traditionally associated with increased symptoms as lung function deteriorates. Follow-up times in previous cohort studies were limited to a few years. Interestingly, newer longer observational studies show a more comprehensive picture on disease progression over time. Therefore, the question on the relevancy of the follow-up time in cohort studies remains open. Methods : The ON-SINT study is an observational, retrospective, nationwide, real-life cohort study, in which patients diagnosed with COPD were recruited between December 2011 and April 2013 by primary care (PC) and secondary care (SC) physicians. Patients were evaluated at the inclusion visit and at the initial visit when the diagnosis of COPD was first established. Distribution of lung function decline over the years was studied comparing those cases with longer follow-up times, with the median of the distribution as the cutoff point. Results : The sample included 1214 patients of which 857 (70.6%) were recruited by PC and 357 (29.4%) by SC physicians. Median follow-up time was 6.26 years. Mean annual change in the complete cohort were -4.5 (222) ml year -1 for FVC and 5.5 (134) ml year -1 for FEV 1 . We confirm the variable distribution of FEV 1 decline and found that longer follow-up periods reduce this variability. Of note, FEV 1 decline was different between groups (shorter: 19.7 [180.4] vs longer: -9.7 [46.9]; p  = 0.018). Further, our data revealed differences in the clinical presentation according to follow-up times, with special emphasis on dyspnea (OR: 1.035; 95%CI: 1.014-1.056), exacerbations (OR 1.172; 95%CI 1.045-1.315) and CAT scores (OR 1.047; 95%CI 1.019-1.075) being associated with longer follow-up times. Conclusions : This study describes the impact of follow-up periods on lung function variability, and reveals differences in clinical presentation according to follow-up times, with special emphasis on dyspnea, exacerbations and CAT scores., Competing Interests: No potential conflict of interest was reported by the authors.

Introduction: Despite widespread recommendations to use standardized questionnaires and multidimensional indices for the assessment of patients with chronic obstructive pulmonary disease (COPD), few data are available on the application of these tools in clinical practice. This study evaluates the attitude of physicians participating in the On-Sint cohort toward the use of health status questionnaires and multidimensional indices, as well as toward the frequency of visits and spirometry in primary care and specialized care., Methods: During the constitution of the On-Sint cohort, the participating physicians were surveyed about their clinical practice. They were questioned on the frequency of spirometry and visits and on the use of various questionnaires and indices. The health status questionnaires assessed were St. George's respiratory questionnaire, chronic respiratory questionnaire, airways questionnaire 20 and COPD assessment test (CAT). Physicians were also asked about the use of the medical research council (MRC) dyspnea scale and multidimensional indices such as body mass index, airflow obstruction, dyspnea, exercise capacity (BODE)., Results: Of the 356 physicians who participated in the study, 258 (72.5 %) completed the investigator's questionnaire (185 primary care, 73 specialized care). Nonscheduled visits were inversely proportional to the severity of COPD. Overall, 34.1% reported using health status questionnaires, mainly CAT (20.9%). We found differences between primary and specialized care in the use of multidimensional indices (84.9% vs 47.6%; P < 0.001). Of all the participants, 33.3% reported using the MRC scale and 28.7% the BODE index., Conclusions: Multidimensional indices and questionnaires are not commonly used with some differences between primary care and specialized care physicians. There is a considerable variability in the frequency of follow-up visits and spirometry., (© 2015 John Wiley & Sons Ltd.)

Background: Although tobacco smoke is the main risk factor for chronic obstructive pulmonary disease (COPD), other inhaled toxics have also been associated with the disease. The present study analyzes data from exposure to these substances in a cohort of patients with COPD and assesses their impact on the clinical presentation of the disease., Methods: This is a cross-sectional analysis of the Clinical presentation, diagnosis and course of chronic obstructive pulmonary disease (On-Sint) study. All patients were smokers or ex-smokers as per protocol. In addition, during the inclusion visit patients were enquired about their occupational and biomass exposure history. The clinical features of patients with and without an added risk factor to tobacco were compared and those significant were entered in a multivariate logistic regression analysis, expressed as odds ratio (OR)., Results: The sample size was 1214 patients with COPD, of which 1012 (83.4%) had tobacco as the only risk factor and 202 (16.6%) had additional ones, mainly 174 (14.3%) with occupational gases and 32 (2.6%) with biomass exposure. The geographical distribution of this exposure showed a preference for the northern parts of the country and the East coast. The biomass exposure was rather low. Male gender (OR: 2.180), CAT score (OR: 1.036) and the use of long-term oxygen therapy (OR: 1.642) were associated with having an additional risk factor in the multivariate analysis., Conclusions: Occupational exposures are more common than biomass in Spain. COPD caused by tobacco plus other inhalants has some differential features and a more impaired quality of life., (Copyright © 2016 SEPAR. Publicado por Elsevier España, S.L.U. All rights reserved.)

Background and Objective: The increase in the prevalence of type 2 diabetes mellitus (T2DM) is related to the increase of obesity. We aimed to determine the Spanish prevalence of T2DM in patients with overweight or obesity attended by either family or specialist physicians., Patients and Method: Cross-sectional, multicenter and simultaneous 2-phase design, performed under clinical conditions. Phase A was designed to determine T2DM prevalence: 169,023 patients were recruited. Phase B was designed to define socio-demographic, clinical and metabolic profile of T2DM according to the body mass index (BMI): 7,754 patients were included., Results: T2DM prevalence in overweight or obese patients was 23.6%; 17.8% of overweight patients were diabetic and T2DM was present in 34.8% of obese people. According to sex, 20.2% of men and 16.4% of women had T2DM. Overall, the mean of risk factors related to T2DM was 4.4 (SD 0,8); out of them, 92.6% patients had dyslipidemia, 73.7% hypertension and 62.5% performed a low physical activity. 37.8% of diabetic patients had vascular involvement. Only 43.1% of patients showed a proper metabolic control of T2DM (glycosilated hemoglobin<7%)., Conclusions: T2DM is related to overweight and obesity and higher the BMI is, higher the T2DM prevalence. Dyslipidemia, hypertension and a low physical activity in diabetic patients are more frequent when BMI increases. Patients with inadequate metabolic control have a higher BMI., (Copyright © 2012 Elsevier España, S.L. All rights reserved.)