ABSTRACT
OBJECTIVE: We aim to determine the effect of a fixed-dose combination (FDC) of tiotropium/olodaterol on Physical activity (PA) in patients with chronic obstructive pulmonary disease (COPD) in a real world setting. METHODS: COPD patients were prospectively enrolled to evaluate the effect of a FDC of tiotropium/olodaterol inhaler therapy via the Respimat® Soft Mist™ inhaler (SMI) on the physical functioning scale (PF-10), and the general condition of the patient as assessed by the physician (Physician's Global Evaluation, PGE), and the patient's satisfaction after 6 weeks of treatment. The primary end-point was the percentage of patients with therapeutic success at 6th week follow-up, defined as a ≥10-points increase in the standardised PF-10 score from baseline. RESULTS: A total of 257 patients from 57 sites were enrolled, and 234 completed the follow up. After 6 weeks of treatment, 155 out of 234 patients (66.2%) showed therapeutic success in the physical functioning score, coupled with significant improvement in PGE score: 78 (33.3%) patients with good/excellent PGE score at baseline, increasing to 172 (73.5%) at 6th week (p<0.0001). The patient's satisfaction was excellent: 77.2% reporting to be satisfied/very satisfied with the treatment, 79.9% with inhaling and 79.0% with the handling of SMI device. 1.6% of patients reported an investigator-defined drug-related adverse event. CONCLUSION: Treatment of COPD patients with a FDC of tiotropium/olodaterol SMI for 6 weeks resulted in significant improvements in the patients' condition as assessed by patients and physicians, with no new safety findings.
Subject(s)
Pulmonary Disease, Chronic Obstructive , Administration, Inhalation , Adrenergic beta-2 Receptor Agonists , Bronchodilator Agents/therapeutic use , Drug Combinations , Exercise , Forced Expiratory Volume , Humans , Nebulizers and Vaporizers , Pulmonary Disease, Chronic Obstructive/drug therapy , Treatment OutcomeABSTRACT
Objetivo: La enfermedad pulmonar obstructiva crónica (EPOC) es una enfermedad muy prevalente, con gran repercusión social, epidemiológica, clínica y económica, siendo diferente el patrón de expresión de la enfermedad en hombres y en mujeres. La EPOC es una enfermedad infradiagnosticada. La idea ampliamente extendida de que es una enfermedad que afecta principalmente a los hombres puede provocar que el infradiagnóstico de la población femenina sea aún mayor. Si a esto le sumamos unas características clínicas diferentes, el esfuerzo de sensibilización de los profesionales sanitarios hacia la EPOC femenina debe ser aún mayor para que no pase desapercibida. El presente estudio analiza las características clínicas y funcionales de una muestra representativa española de mujeres con EPOC, con la finalidad de conocer mejor cuál es el perfil clínico de la EPOC femenina en nuestro medio y la repercusión de la enfermedad en la calidad de vida y en el grado de actividad física de nuestras pacientes. Pacientes y métodos: Estudio epidemiológico, trasversal, multicéntrico, observacional y no intervencionista. 379 neumólogos reclutaron los 5 primeros casos consecutivos de pacientes con EPOC de sexo femenino seguidos en consultas de Neumología. Los criterios de inclusión fueron ser ≥40 años y tener antecedentes de tabaquismo con un índice de paquetes-año (IPA) acumulado ≥ 10 años. Se recogieron datos sociodemográficos, clínicos y espirométricos en una única visita. Resultados: Se evaluaron 1.732 mujeres. La media de edad fue de 61,6 ± 10 años, con un tiempo medio desde el diagnóstico de la EPOC de 7,5 ± 6,4 años. El 60,1% eran fumadoras activas, con un IPA acumulado de 35,7 ± 19,9. El 90% había cursado estudios primarios o superiores. El 60,9% tenía sobrepeso u obesidad y tenían antecedentes de depresión y ansiedad el 25,5% y 43,1% respectivamente. El 12,3% presentaba una EPOC leve, el 48,7% moderada, el 32,6% grave y el 6,3% muy grave. El 46,9% presentaba disnea grado 3-5 según la clasificación del Medical Research Council (MRC). Las puntuaciones del cuestionario de calidad de vida SF-12 en sus componentes físico (PCS) y mental (MCS) fueron 37,6 ± 10,5 y 45,7 ± 12,0, respectivamente. La puntuación total de la versión española validada del London Chest Activity of Daily Living (LCADL) fue de 27,2 ± 10,9. La media de exacerbaciones en el año previo fue de 1,5 ± 1,6. En cuanto al tratamiento de base el 78,4% estaban recibiendo anticolinérgicos de acción prolongada, el 65,3% combinaciones de agonistas-b2 de acción prolongada y corticosteroides y el 63,1% b2-agonistas de acción corta. Conclusiones: Las mujeres con EPOC de nuestra serie están en una edad en la que podrían estar trabajando activamente. La gravedad de la enfermedad que presentan repercute en su calidad de vida y en sus actividades diarias
Background: Chronic obstructive pulmonary disease (COPD) clinical trial populations are predominantly male; thus, the female population is not well characterized. We aimed to determine the clinical and socio-demographic profile of women with COPD from a large female patient population in Spain. Methods: Multicenter, cross-sectional, epidemiological study. 379 pulmonologists recruited the first 5 COPD female patients ≥ 40 yrs, with smoking history ≥ 10 package year index (PYI) and follow-up at pulmonologist clinics. Clinical, spirometric and socio-demographic data were collected during a single visit. Results: 1,732 women were evaluated. Mean age: 61.6 ± 10 yrs; Average time since COPD diagnosis: 7.5 ± 6.4 yrs; 60.9% were overweight or obese; 90% had at least a primary education; 60.1% were current smokers; PYI: 35.7 ± 19.9; 25.5% and 43.1% had a history of depression and anxiety, respectively; COPD severity: 12.3% stage I, 48.7% II, 32.6% III and 6.3% IV; 80% had dyspnea Medical Research Council (MRC) degree 3-5; Post-bronchodilator forced expiratory volume in the first second (FEV1)/ forced vital capacity (FVC) ratio: 57.8 ± 12.2; Oxygen saturation: 93.8 ± 3.3%; Physical Component Summary (PCS) and Mental Component Summary (MCS) scores were 37.6 ± 10.5 and 45.7 ± 12.0, respectively; London Chest Activity of Daily Living (LCADL) total score: 27.2 ± 10.9. There were 1.5 ± 1.6 exacerbations in the previous year. 78.4%, 65.3% and 63.1% were receiving long-acting anticholinergics, long-acting b2-agonist/corticosteroids and short-acting b2-agonists. Conclusions: Women with COPD are still at an age where they could be actively working but demonstrate severe disease, which impacts greatly on their health-related quality of life and daily activities
Subject(s)
Humans , Female , Adult , Middle Aged , Aged , Aged, 80 and over , Pulmonary Disease, Chronic Obstructive/epidemiology , Pulmonary Disease, Chronic Obstructive/diagnosis , Women , Quality of Life , Motor Activity , Health Profile , Depression , Anxiety , Tobacco Use Disorder , Tobacco Use , Tobacco Smoke Pollution , Comorbidity , Cross-Sectional Studies , Multicenter Studies as Topic , Observational Studies as Topic , Epidemiologic StudiesABSTRACT
AIMS: The severity of chronic obstructive pulmonary disease (COPD) is associated to patients' health-related quality of life (HRQL). Physical impairment increasingly affects daily activities creating economic, social and personal burden for patients and their families. This burden should be considered in the management of COPD patients; therefore, we intended to assess the impact of the disease severity on physical disability and daily activities. METHODS: Two epidemiological observational cross-sectional descriptive studies were carried out in 1596 patients with moderate COPD and 2012 patients with severe or very severe COPD in the routine clinical practice. Demographic and basic clinical-epidemiological data were collected and patients completed questionnaires to assess their physical disability because of COPD [Medical Research Council (MRC)], COPD repercussion on daily activities [London Chest Activity of Daily Living (LCADL)], job, economy and family habits and their health status [EQ-5D visual analogue scale (VAS)]. RESULTS: In all, 37% of severe/very severe COPD patients and 10% of moderate (p < 0.0001) had MRC grades 4 and 5. Mean global LCADL was significantly higher in severe/very severe than in moderate patients [29.6 (CI 95%: 28.91-30.25) vs. 21.4 (CI 95%: 20.8-21.9); p < 0.0001]. COPD job impact and economic and family habits repercussions were significantly higher and health status significantly worse in severe/very severe cases than in patients with moderate COPD. CONCLUSIONS: COPD severity is highly associated with physical disability by MRC grading, with functionality on daily activities and with impairment of other social and clinical activities. Moderate COPD patients show already a significant degree of impairment in all these parameters.
