Budesonide/formoterol as effective as prednisolone plus formoterol in acute exacerbations of COPD A double-blind, randomised, non-inferiority, parallel-group, multicentre study

<p>Abstract</p> <p>Background</p> <p>Oral corticosteroids and inhaled bronchodilators with or without antibiotics represent standard treatment of COPD exacerbations of moderate severity. Frequent courses of oral steroids may be a safety issue. We wanted to evaluate in an out-patient setting whether a 2-week course of inhaled budesonide/formoterol would be equally effective for treatment of acute COPD exacerbations as standard therapy in patients judged by the investigator not to require hospitalisation.</p> <p>Methods</p> <p>This was a double-blind, randomised, non-inferiority, parallel-group, multicentre study comparing two treatment strategies; two weeks' treatment with inhaled budesonide/formoterol (320/9 μg, qid) was compared with prednisolone (30 mg once daily) plus inhaled formoterol (9 μg bid) in patients with acute exacerbations of COPD attending a primary health care centre. Inclusion criteria were progressive dyspnoea for less than one week, FEV₁30–60% of predicted normal after acute treatment with a single dose of oral corticosteroid plus nebulised salbutamol/ipratropium bromide and no requirement for subsequent immediate hospitalisation, i.e the clinical status after the acute treatment allowed for sending the patient home.</p> <p>A total of 109 patients (mean age 67 years, 33 pack-years, mean FEV₁45% of predicted) were randomized to two weeks' double-blind treatment with budesonide/formoterol or prednisolone plus formoterol and subsequent open-label budesonide/formoterol (320/9 μg bid) for another 12 weeks. Change in FEV₁was the primary efficacy variable. Non-inferiority was predefined.</p> <p>Results</p> <p>Non-inferiority of budesonide/formoterol was proven because the lower limit of FEV₁-change (97.5% CI) was above 90% of the efficacy of the alternative treatment. Symptoms, quality of life, treatment failures, need for reliever medication (and exacerbations during follow-up) did not differ between the groups. No safety concerns were identified.</p> <p>Conclusion</p> <p>High dose budesonide/formoterol was as effective as prednisolone plus formoterol for the ambulatory treatment of acute exacerbations in non-hospitalized COPD patients. An early increase in budesonide/formoterol dose may therefore be tried before oral corticosteroids are used.</p> <p>Clinical trial registration</p> <p>NCT00259779</p

Concomitant therapy with Cineole (Eucalyptole) reduces exacerbations in COPD: A placebo-controlled double-blind trial

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Improved outcomes in patients with chronic obstructive pulmonary disease treated with salmeterol compared with placebo/usual therapy: results of a meta-analysis

BACKGROUND: Several studies have demonstrated that long-acting β(2)-agonists such as salmeterol are beneficial in chronic obstructive pulmonary disease (COPD). A meta-analysis was therefore conducted to review studies in COPD to provide pooled estimates of the effect of salmeterol 50 mcg taken twice daily in addition to usual therapy on several clinically relevant endpoints, when compared with placebo/usual therapy. METHODS: An extensive search of literature and clinical trial databases was conducted using the terms salmeterol, COPD, chronic, obstructive, bronchitis and emphysema. Nine randomized, double-blind, parallel-group, placebo-controlled trials of ≥12 week duration with salmeterol 50 mcg bid treatment in COPD were included (>3500 patients), with a further 14 trials excluded due to study design or reporting timelines. All patients were included, and a sub-group of subjects (84%) with poorly reversible COPD were considered separately. Statistical testing was carried out at the 5% level, except for interaction testing which was carried out at the 10% level. RESULTS: Patients treated with salmeterol over 12 months were less likely to withdraw early from the studies (19% patients compared with 25% on their current usual therapy, p < 0.001), less likely to suffer a moderate/severe exacerbation (34% compared with 39%, p < 0.0001) and had a greater increase in average FEV(1 )(73 mL difference vs placebo/usual therapy, p < 0.0001). Similar differences were found at 3 and 6 months. At all time points, more patients experienced an improvement in health status and also a greater change with salmeterol than with placebo/usual therapy (p < 0.002). There was no evidence of tachyphylaxis to salmeterol over 12 months. CONCLUSION: The meta-analysis confirmed clinically and statistically significant, sustained and consistent superiority of salmeterol 50 mcg bid over placebo/usual therapy on a broad range of outcome measures

Mortality in COPD patients discharged from hospital: the role of treatment and co-morbidity

BACKGROUND: The aim of this study was to analyse mortality and associated risk factors, with special emphasis on health status, medications and co-morbidity, in patients with chronic obstructive pulmonary disease (COPD) that had been hospitalized for acute exacerbation. METHODS: This prospective study included 416 patients from each of the five Nordic countries that were followed for 24 months. The St. George's Respiratory Questionnaire (SGRQ) was administered. Information on treatment and co-morbidity was obtained. RESULTS: During the follow-up 122 (29.3%) of the 416 patients died. Patients with diabetes had an increased mortality rate [HR = 2.25 (1.28–3.95)]. Other risk factors were advanced age, low FEV(1 )and lower health status. Patients treated with inhaled corticosteroids and/or long-acting beta-2-agonists had a lower risk of death than patients using neither of these types of treatment. CONCLUSION: Mortality was high after COPD admission, with older age, decreased lung function, lower health status and diabetes the most important risk factors. Treatment with inhaled corticosteroids and long-acting bronchodilators may be associated with lower mortality in patients with COPD

Evaluation of Asthma Control using Patient Based Measures and Peak Expiratory Flow Rate: " Evaluación del Control del Asma usando Medidas Basadas en el Paciente y Tasas de flujo Expiratorio Máximo"

Objective: Asthma control has not been formally evaluated in the Caribbean. This study evaluated disease control on The Asthma Control Test (ACT), The Royal College of Physicians “Three questions” for Assessing Asthma Control (RCP), peak expiratory flow rate (PEFR) and patients’ self-assessment of control. Subjects and Methods: Asthma control was examined in a cross-section of 205 asthmatics above 16 years of age using the ACT, RCP and on the PEFR % predicted. Scores below 20 and equal to or above 1 on the ACT and RCP respectively, and PEFR below 80% predicted indicated uncontrolled asthma. Patients stated whether they perceived their asthma was controlled or uncontrolled. Results: Overall there were more females (63.9%, p 0.05). Fewer patients (13.2%) achieved control on PEFR > 80% predicted than on the ACT (22.4%) and RCP (18%). The Kappa statistic indicated good reproducibility of the RCP and ACT and concordance between the PEFR and RCP (0.63) and the PEFR and ACT (0.56). Higher education was associated with control on the ACT (p 0.05). Conclusion: Approximately 80% of study asthmatics were uncontrolled, and patients tended to overestimate their disease control. The ACT and RCP instruments were comparable with the PEFR. Efforts to study their validity and formal evaluation of asthma control in Trinidad are recommended. RESUMEN Objetivo: El control del asma no ha sido evaluado formalmente en el Caribe. El estudio evaluó el control de la enfermedad utilizando el Test de Control del Asma (TCA), las “tres preguntas” del Colegio Real de Médicos para evaluar el control del asma (CRM), y la tasa de flujo expiratorio máximo (FEM) así como la autoevaluación del control por parte de los pacientes. Sujetos y métodos: El control del asma fue examinado en una sección transversal de 205 asmáticos de más de 16 años de edad, mediante el TCA, el CRM, y la predicción del FEM%. Las puntuaciones por debajo de 20 e iguales o por encima de 1 en el TCA y el CRM respectivamente, por debajo del 80% de predicción de la FEM, indicaban asma no controlada. Los pacientes informaban si percibían su asma como controlada o no controlada. Resultados: En general hubo más (p 0.05). Menos pacientes (13.2%) lograron un control con FEM > 80% de predicción que con TCA (22.4%) y CRM (18%). La estadística Kappa indicó una buena reproductibilidad de CRM y TCA, así como concordancia entre FEM y CRM (0.63) y FEM y TCA (0.56). Un nivel de educación más alto estuvo asociado con el control en TCA (p 0.05). Conclusión: Aproximadamente el 80% de los asmáticos fueron no controlados, y los pacientes sobrestiman su control de la enfermedad. Los instrumentos TCA y CRM fueron comparables con la FEM. Se recomienda hacer esfuerzos por estudiar la validez de estos, así como la evaluación formal del control del asma en Trinidad