Consultas a urgencia y valores espirométricos tras el reemplazo de salmeterol/fluticasona por budesonida/formoterol en pacientes con asma moderada a grave / Emergency consultations and spirometric values after replacement of salmeterol/fluticasone with budesonide/formoterol in patients with moderate to severe asthma

El asma se caracteriza por su impacto deletéreo que incluye gran coste económico para el sistema de salud. En pacientes con asma mal controlada a pesar del tratamiento, se propone un régimen de mantenimiento con corticoides inhalados y formoterol. El objetivo del presente estudio observacional retrospectivo fue evaluar las modificaciones espirométricas tras el cambio del medicamento controlador en pacientes con asma moderada a severa asistidos en el Hospital Clínico de Magallanes de Punta Arenas, así como también cuantificar la modificación en el número de exacerbaciones graves (consulta a un servicio de urgencia y/u hospitalización por asma). Participaron 61 adultos con asma moderada a severa (mediana de edad: 60 años [rango: 21-87], mujeres: 69,4%; comorbilidad atópica/alérgica: 79%; otras comorbilidades: 46,8%) en los que se cambió el tratamiento con fluticasona/salmeterol 250/25 μg por budesónida/formoterol 160/4,5 μg. No se observaron cambios significativos en los índices espirométricos tras el cambio. Con el tratamiento inicial, el 46,9% presentó ≥ 1 visita a urgencias (total: 50 consultas). Tras el cambio por budesonida/formoterol, el 21% requirió al menos una visita a urgencias (total: 14 consultas; p < 0,01). La proporción de pacientes con ≥ 2 consultas a urgencias fue de 19,7% con el tratamiento basal y de 1,6% tras el cambio a budesonida/formoterol (p < 0,01). No se observaron diferencias significativas en la cantidad de hospitalizaciones. En este estudio del mundo real de pacientes con asma moderada a grave, el cambio del tratamiento a budesonida/formoterol se asoció con reducción significativa de las consultas a urgencias, a pesar de no detectarse cambios de significación estadística en los índices espirométricos habituales.

Asthma is characterized by its deleterious impact, including a high cost to the healthcare system. In patients with poorly controlled asthma despite treatment, a maintenance regimen of inhaled corticosteroids and formoterol is proposed. The aim of this retrospective, observational study was to evaluate the spirometric changes after switching the controller medication in patients with moderate to severe asthma attended in our institution ("Hospital Clínico de Magallanes"), as well as the variation in the number of severe exacerbations (consultation to an emergency department and/or hospitalization for asthma). Sixty-one adults with moderate to severe asthma (median age: 60 years-old [range: 21-87], women: 69.4%; atopic/allergic comorbidity: 79%; other comorbidities: 46.8%) in whom treatment with fluticasone/salmeterol 250/25 μg was switched to budesonide/formoterol 160/4.5 μg participated in our study. No significant changes in spirometric parameters were observed after the replacement treatment. With the initial treatment, 46.9% patients presented ≥ 1 visit to the emergency department (total: 50 visits). After the switch to budesonide/formoterol, 21% required at least one emergency department visit (total: 14 consultations; p < 0.01). The proportion of patients with ≥ 2 emergency department visits was 19.7% with baseline treatment and 1.6% after switching to budesonide/formoterol (p < 0.01). No significant differences were observed in the number of hospitalizations. In this real-world study of moderate to severe asthma patients, switching to budesonide/formoterol was associated with a significant reduction in emergency department visits, despite no statistically significant changes in the usual spirometric parameters.

Estudio aleatorizado, cruzado, de no inferioridad para evaluar la eficacia, la seguridad y la tolerabilidad de dos formulaciones de budesonida/fumarato de formoterol en adultos asmáticos / Randomized, Crossover, Non-Inferiority Study to Evaluate the Efficacy, Safety and Tolerability of Two Budenoside/Formoterol Fumarate Formulations in Asthmatic Adults

RESUMEN El asma es un grave problema de salud mundial. Según el último informe del Ministerio de Salud, 1 380 000 sujetos padecen asma en la Argentina.1 Las guías internacionales (Europa, Estados Unidos, OMS) varían en su enfoque para definir la equivalencia y la posibilidad de intercambio de los productos para inhalación respiratorios. Si bien es posible un enfoque in vitro, en general las guías recomiendan brindar más indi cios clínicos que avalen la posibilidad de intercambiar el producto innovador por otro posteriormente desarrollado con iguales principios activos en polvo seco para inhalar. Este estudio, aleatorizado de fase IV, se realizó para establecer la eficacia, seguridad y tolerabilidad de Neumoterol® 400 en comparación con el producto medicinal de refe rencia Symbicort forte budesonida/fumarato de formoterol 320/9 μg, indicados 2 veces al día en pacientes asmáticos. Además, se evaluó la preferencia de los pacientes por uno u otro dispositivo. Se demostró la no inferioridad de la formulación evaluada en comparación con el pro ducto medicinal de referencia. El límite inferior del IC del 95% para la diferencia entre los tratamientos fue mayor que el margen predefinido de no inferioridad de -125 mL (diferencia: 0,044 l [IC del 95%: -0,008 a 0,096]). Asimismo, se comprobaron valores más altos para el AUC0-10h del FEV1 y un mayor cambio respecto del puntaje basal en la prueba de control del asma el día 29 para las cápsulas de budesonida/fumarato de formoterol 400/12 μg. En un análisis exploratorio sobre la preferencia de los pacientes por los dispositivos, una mayor proporción de participantes expresaron su preferencia global por la cápsula de budesonida/fumarato de formoterol 400/12 μg. No se informa ron diferencias en la incidencia de AE o SAE (del inglés Adverse event: evento adver so y Severe Adverse Event: evento adverso severo) graves durante el tratamiento o después de este. El perfil de seguridad de ambos productos en general concordó con el perfil comprobado de budesonida/fumarato de formoterol.

ABSTRACT Asthma is a serious worldwide health problem. According to the last report of the Min istry of Health, 1,380,000 subjects suffer from asthma in Argentina.1 The International Guidelines (Europe, United States, WHO [World Health Organization]) have varying approaches to define the equivalence and possibility of switching respiratory inhalation products. Whereas an in vitro approach is possible, in general Guidelines recommend providing more clinical evidence that support the possibility of switching from the inno vative product to another one subsequently developed with the same active ingredient in the form of dry powder inhaler. This randomized, phase IV study has been conduct ed to establish the efficacy, safety and tolerability of Neumoterol® 400 compared to the reference medicinal product Symbicort forte, budenoside/formoterol fumarate 320/9 μg twice a day in asthmatic patients. Also, the patients' preference for one device or the other has been evaluated. The evaluated formulation has proven to be non-inferior compared to the reference medicinal product. The lower 95% CI (confidence interval) limit for the difference be tween treatments was higher than the predefined non-inferiority margin of -125 mL (difference: 0.044 l [95% CI: -0.008 to 0.096]). Also, higher values were evidenced for the AUC0-10h (are under the curve) of the FEV1 (forced expiratory volume in the first second) and a more important change of the baseline score in the asthma control test on day 29 for the budenoside/formoterol fumarate capsules of 400/12 μg. In one exploratory test about the patients' preference for one device or the other, a higher pro portion of participants expressed their global preference for the budenoside/formoterol fumarate capsule of 400/12 μg. No differences were reported in the incidence of AEs (adverse events) or SAEs (serious adverse events) during or after the treatment. The safety profile of both products in general agreed with the verified profile of budenoside/ formoterol fumarate.

Simultaneous Estimation Of Mometasone Furoate And Formoterol Fumarate By Hplc Method In Rotacaps

Objective: To develop and validate a simple and sensitive RP-HPLC method for the simultaneous determination of mometasone furoate (MOM) and formoterol fumarate (FOR) in pharmaceutical dosage forms. Methods: In RP-HPLC method, chromatographic separation was achieved using a mixture of a solvent system consisting of methanol–water (pH 3.5) in the ratio of 85:15 % v/v at a flow rate of 1 ml/min and detection was carried out at 225 nm. Results: The run time for the simultaneous estimation of drugs for the proposed method was 10 min as drugs eluted at 5.217 min (MOM) and 8.650 min (FOR). The linearity was found in the range of 33.33-299.97 μg/ml and 1-9 μg/ml for MOM and FOR, respectively. The values of limit of detection and limit of quantification were 3.634, 0.266 µg/ml and 11.014, 0.807 µg/ml, which indicates the sensitivity of the method for the estimation of MOM and FOR, respectively. The results of recovery studies for both the drugs were within the range i.e. 98.87-101.48 % which indicates the accuracy of the method. Relative standard deviation obtained from repeatability and reproducibility studies were less than 2% indicates the precision of the method. The proposed method was validated according to ICH guidelines. Conclusion: The proposed RP-HPLC method was found to be sensitive and precise because of the low LOD, LOQ and % RSD values (<2). The proposed work does not require acetonitrile and ion pairing reagent as compared to the reported methods. Therefore, method can be used preferably for routine analysis due to its simplicity and economic advantages.

Effects of Fufang-Haqing capsule with formoterol in the treatment of pulmonary emphysema combined with chronic wheezing bronchitis / 国际中医中药杂志

Objective To explore the effects of Fufang-Haqing capsule with formoterol in the treatment of elderly pulmonary emphysema combined with chronic wheezing bronchitis. Methods A total of 156 patients with elderly pulmonary emphysema combined with chronic wheezing bronchitis in our hospital were divided into control group (88 cases) and observation group (88 cases). The control group was treated with formoterol, the observation group was treated with Fufang-Haqing capsule combined with formoterol. Both group treatment last three months. In the 2 groups, the levels of lung function indicators (FEV1, FEV1/FVC, PEF and PEFR), inflammatory markers [Matrix metalloproteinase inhibitors-1 (TIMP-1), interleukin-17 (IL-17), matrix metalloproteinase-9 (MMP-9) and interleukin-8 (IL-8)], immune function indicators [T lymphocyte subgroup (CD3+ and CD4+), immunoglobulin (IgA, IgG and IgM)] were detected before and after the treatment. During the treatment, the adverse actions were observed. Results The effect rate in treatment group was 93.2% (82/88), significantly higher than 80.7% (71/88) in control group (Z=3.781, P<0.05). After the treatment, the levels of FEV1 (2.89 ± 0.37 L vs. 2.22 ± 0.33 L, t=3.781), FEV1/FVC (65.10% ± 6.67% vs. 57.56% ± 5.98%, t=3.894), PEF (6.76 ± 0.69 L/S vs. 5.57 ± 0.59 L/S, t=3.351) and PEFR (3.67 ± 0.39 L/S vs. 2.87 ± 0.32 L/S, t=3.561) in the treatment group were significantly higher than those in the control group (P<0.05). The TIMP-1, IL-17, IL-8 and MMP-9 in the treatment group were significantly lower than those in the control group (t were 3.567, 3.692, 3.491, 3.394, all Ps<0.05), while the levels of CD3+, CD4+, IgA, IgG and IgM were in the treatment group were significantly higher than those in the control group (t were 3.791, 3.593, 3.258, 3.682, 3.526, all Ps<0.05). There was no significantly difference between the 2 groups in the adverse actions. Conclusions The Fufang-Haqing capsule with formoterol in the treatment of elderly pulmonary emphysema combined with chronic wheezing bronchitis showd good effect, could promote the levels of lung function, inflammatory and immune function.

Clinical study of Xiao'er Qingfeihuatan oral solution in the treatment of children with chronic cough / 中国基层医药

Objective To investigate the clinical efficacy of Qingfeihuatan oral solution in the treatment ofchildren with chronic cough.Methods According to the digital table,a total of 116 patients with cough variantasthma induced by chronic cough were randomly divided into control group and observation group,each group had58 cases.The two groups were given budesonide and formoterol fumarate powder for treatment,on this basis,theobservation group added Xiao'er Qingfeihuatan oral solution,the two groups were continuously treated for 4 weeks.Thechanges of lung function indicators,clinical efficacy and adverse reaction etc were observed.Results Aftertreatment,the clinical total effective rate of the observation group was 94.8％,which of the control group was 77.6％,the difference was statistically significant (x2 =3.625,P ＜ 0.05).The lung function indicators of FEV,FEV1 andFEV1/FEV in the two groups had statistically significant differences between before and after treatment (all P ＜0.05),but the pulmonary function indicators of FEV,FEV1 and FEV1/FEV in the observation group compared withthe control group had statistically significant differences (all P ＜ 0.05).The incidence rate of adverse reactions in theobservation group was 13.8％,which in the control group was 15.5％,the difference was not statistically significant(x2 =0.034,P ＞ 0.05).Conclusion On the basis of routine treatment,Qingfeihuatan oral solution in the treatmentof children with chronic cough can significantly improve the pulmonary function of patients,improve the clinicaltreatment effect,and has good safety and great clinical significance.

Clinical Efficacy of Budesonide and Formoterol Fumarate Powder in the Treatment of Patients with Bronchial Asthma and Its Effect on the Serum Levels of Inflammatory Factors / 现代生物医学进展

Objective:To explore the clinical efficacy of Budesonide and Formoterol Fumarate Powder in the treatment of patients with bronchial asthma and its effect on the serum levels of inflammatory factors.Methods:123 cases treated and diagnosed as bronchial asthma in our hospital from February,2014 to February,2016 were randomly divided into the observation group (65 cases) and control group (58 cases).The serum levels of IL-17,IL-33,MMP-9,pulmonaryfunction,quality of life,total effective rate and incidence of adverse reactions were compared between the two groups.Results:The total effective rate of observation group was 92.3％,which was significantly higher than that of the control group (81.03％,P＜0.05).After therapy,the serum level ofIL-17,IL-33 in both groups were largely decreased compared with those before therapy (p＜0.05),and those of observation group were significantly lower than the control group (p ＜0.05);the serum level of MMP-9 in both groups showed no statistical difference compared with that of before therapy.Similarly,the level of FEV1,PEF and FEV1/FVC of observation group were obviously increased compared with those before therapy (p＜0.05) and were significantly higher than those of the control group (p＜0.05);the quality of life in the observation group was better than that of the control group based on the SGRQ score (p ＜0.05).Conclusion:Budesonide and Formoterol Fumarate Powder was effective on the patients with chronic bronchial asthma,which could control the inflammatory reactions,improve the pulmonary function as well as the quality of life.

Effect of ipratropium bromide combined with budesonide/formoterol fumarate inhalation powder on serum IgE,FeNO and lung function of bronchial asthma patients / 中国生化药物杂志

Objective To investigate the effect of ipratropium bromide combined with budesonide /formoterol fumarate inhalation powder on serum FeNO and lung function of bronchial asthma patients.Methods 102 cases with clear bronchial asthma during Jan 2013 and Mar.2015 from the affiliated Qianfo Hill Hospital of Shandong University were randomly divided into three groups, control group A (34 cases) were treated with ipratropium bromide, control group B (34 cases) were treated with budesonide/formoterol fumarate powder, experiment group (34 cases) were given ipratropium bromide combined with budesonide/formoterol fumarate powder, all groups were treated for 6 months.Pulmonary function, serum FeNO and IgE levels, clinical efficacy were compared after treatment.Results The effective rate of control group A, B (70.59%, 67.65%) were significantly lower than experiment group (91.18%), the difference were significant (P<0.05).FEV1, FVC, FEV1%pre of experiment group were significantly higher than control group A and B after the treatment.Serum IgE and FeNO concentration were significantly lower than control group A, B, the difference were significant ( P<0.05 ) .Conclusion Ipratropium bromide combined with budesonide/formoterol fumarate powder for inhalation in bronchial asthma patients can effectively reduce FeNO concentration, improve lung function.

Curative Effect of Chuankezhi Injection Combined with Budesonide and Formoterol Fumarate Powder for Inhalation in the Treatment of Chronic Obstructive Pulmonary Disease / 中国药师

Objective:To observe the efficacy of Chuankezhi injection combined with budesonide and formoterol fumarate powder for inhalation in the treatment of chronic obstructive pulmonary disease ( COPD) . Methods:Totally 120 patients with COPD were ran-domly divided into two groups:the observation group inhaled budesonide and formoterol fumarate powder for inhalation combined with intramuscular injection of Chuankezhi injection, and the control group inhaled budesonide and formoterol fumarate powder for inhala-tion. The treatment course was 28 days. The pulmonary function indices [ FEV1% expected value, FEV1 /FVC, 6 min walking dis-tance (6MWD)], the times of acute exacerbation and the adverse drug reactions during the treatment were observed and compared be-tween the two groups. Results:After the treatment, the lung function and 6MWD were improved in the two groups, and the improve-ment of FEV1% expected value in the treatment group was more obvious than that in the control group [(59. 7+12. 1)% vs (49. 8+11. 3)%, P<0. 05]. The number of patients with at least once of acute exacerbation was significantly reduced in the treatment group when compared with that in the control group (35% vs 62%, P<0. 01). The incidence of adverse drug reactions in the two groups showed no significant difference. Conclusion:Chuankezhi injection combined with budesonide and formoterol fumarate powder for in-halation can notably improve the lung function in the patients with COPD and reduce the times of acute exacerbation without effect on the incidence of adverse drug reactions.