[CHARACTERISTICS OF BUDEFORU® FOR BUDESONIDE AND FORMOTEROL MIXTURE].

BACKGROUND: Recently, BudeForu® (BF), a generic of Symbicort Turbuhaler® (SMB), is widely used in Japan. Although appearance of BF resembles to SMB, several differences in length, weight, and side-hole sizes are seen with precise inspection. As particle releases from the inhalation device is strongly influenced by its mechanical characteristics, we compared their particle release patterns. METHODS: An inhalation simulator generated either ramp-up or triangular (time to reach peak inhaling flow (PIF) = 0.42 s) inhalation pattern. Time trajectories of inhaled flow and released particles from either device were depicted with a photo-reflection method. Internal resistances of them were also measured. RESULTS: Particle release patterns of both dry powder inhalers resembled each other. Immediately after release from the inhaler, they reached the peak value and then completed in 0.5 s. In either ramp-up or triangular inspiration pattern, a single burst developed at early inhalation. There were linear relationships between PIFs and emitted doses. The regression lines using ramp-up patters were: Y = 0.00241 X - 0.039, r2 = 0.700, p ＜ 0.0001 (BF), Y = 0.00210 X - 0.038, r2 = 0.654, p ＜ 0.0001 (SMB), and those using triangular patterns were: Y = 0.00223X － 0.0015, r2 = 0.445, p ＜ 0.0001 (BF), and Y = 0.00229X － 0.0023, r2 = 0.687, p ＜ 0.0001 (SMB). Internal resistances of the BF and SMB were 0.105±0.004 and 0.119±0.105 cmH2O0.5/L/min respectively. CONCLUSIONS: Present experimental study suggested that aerodynamic characteristics of BF were quite similar to those of SMB.

Real-life association between inhaler technique, patient preference and asthma control in patients with uncontrolled asthma switched to budesonide/formoterol DuoResp® Spiromax® combination.

Objective: In asthma, treatment effectiveness is strongly influenced by the quality of inhaler use. New devices such as Spiromax® have been specifically developed to improve ease of use. It is crucial to determine whether switching to such a device improves inhaler technique and clinical outcomes, and to identify factors associated with handling errors.Methods: This observational study assessed inhaler device handling errors in 1435 asthma patients recruited via 135 participating physicians in France, before and after switching therapy from the Symbicort Turbuhaler® or Seretide® Diskus® to DuoResp® Spiromax®. Patients received training in the use of their new device at baseline and were re-assessed after three months.Results: After three months of use, 67% of patients were using the DuoResp® Spiromax® with no handling errors, and 88% with no critical errors. The presence of comorbidities was associated with handling errors overall. Concurrent illness potentially affecting device handling and previous training were associated with critical device handling errors. Most patients (85.4%) preferred DuoResp® Spiromax® over their previous device. Levels of inadequately controlled or uncontrolled asthma were reduced from baseline among patients using DuoResp® Spiromax® (8.6% versus 64.6%), and were higher in patients with critical handling errors.Conclusions: Effective patient education, correct inhaler technique, treatment adherence and devices associated with high patient satisfaction are interrelated factors key to the successful delivery of inhaled asthma therapy. Inhaler technique and patient device satisfaction should be routinely assessed in treated patients with uncontrolled asthma. Supplemental data for this article can be accessed at publisher's website.

Assessment of inhalation errors, training time and patient preference for DuoResp® Spiromax® and Symbicort® Turbuhaler® in patients with asthma and COPD.

While poor inhaler technique in asthma and chronic obstructive pulmonary disease (COPD) can compromise the effectiveness of inhaled medications, identifying and quantifying these errors may suggest ways to improve inhalation technique and patient outcomes. The objective of this international, multicentre care improvement programme was to investigate errors in inhaler use (handling errors and inhalation errors) made by patients in handling two dry powder inhalers; DuoResp® Spiromax® and Symbicort® Turbuhaler®. Patients with asthma or COPD aged between 18 and 80 years attending the allergology/pneumology departments of 14 hospitals in Spain and Portugal were included. All assessments were performed during one regular scheduled visit to the study clinic. Among 161 eligible patients (138 with asthma; 23 with COPD), inhalation errors were the most common type of error, with no significant difference between devices in overall total error rate, handling error rate or inhalation error rate. Significantly fewer total errors per patient (1.4 vs. 1.9; p < 0.001) and handling errors per patient (0.5 vs. 0.8; p < 0.001) were observed with DuoResp® Spiromax® compared with Symbicort® Turbuhaler®. The mean number of attempts for patients using DuoResp® Spiromax® to perform two correct procedures was 1.9 (0.6) compared with 2.1 (0.9) attempts for patients using Symbicort® Turbuhaler® (p = 0.016). Compared with Symbicort® Turbuhaler®, DuoResp® Spiromax® was found to be easy to learn how to use (p < 0.001), easy to prepare (p < 0.001), easy to use (p < 0.001), comfortable in terms of weight and size (p = 0.001), and patients felt that they were using the device correctly (p < 0.001). Overall, 79.5% of patients stated that they preferred DuoResp® Spiromax® as their first option over Symbicort® Turbuhaler®. The findings of this study may be useful in developing effective inhaler training programmes and thus improve outcomes in asthma and COPD.

Effect of adjusting the combination of budesonide/formoterol on the alleviation of asthma symptoms.

BACKGROUND: The combination of budesonide + formoterol (BFC) offers the advantages of dose adjustment in a single inhaler according to asthma symptoms. We analyzed the relationship between asthma symptoms in terms of peak expiratory flow (PEF) and dose adjustment by the patient. METHODS: Twenty-eight patients with asthma who used BFC for alleviation of their symptoms (12 men, 16 women; 60 years old) were instructed that the inhaled BFC dose could be increased to a maximum of 8 inhalations per day according to symptom severity. Patients measured and recorded PEF every morning and evening in their asthma diary along with their symptoms and the dose of drugs taken. RESULTS: Sixteen of the 28 patients increased their dose for asthma symptoms. The time to recovery from the asthma symptoms was significantly shorter when cough was the only symptom present compared with dyspnea or wheeze (1.4 vs. 5.3 or 6.6 days, p < 0.05) and when they had only one symptom compared with two or three symptoms (1.3 vs. 5.7 or 10.5, p < 0.01). The relationship between PEF (% of personal best) when the dose was increased (Y) and the days for the increased dose to achieve a PEF greater than PEF in the symptom-free state (X) was determined to be Y = - 0.591X + 89.2 (r2 = 0.299, p < 0.001). CONCLUSION: As a guide for increasing the BFC dose when patients with mild asthma have asthma symptoms, the dose should be increased when cough is present or PEF is decreased to 88.9% (i.e., X = 0.5).

Real-Life Clinical Use of Symbicort® Maintenance and Reliever Therapy for Asthmatic Patients in Korea.

The aim of this study was to examine the daily practice patterns of Symbicort® Maintenance and Reliever Therapy (SMART) in Korean asthmatic patients and to analyze clinical signs related to overuse. This study used an observational, multicenter, noninterventional, prospective, uncontrolled design for examining asthmatic patients prescribed SMART to assess the frequency and pattern of Symbicort® usage as a maintenance and reliever medication. The characteristics of patients showing signs of overuse (frequency of inhalation: 8 or more times per day) were also analyzed. Among the 1,518 patients analyzed, 1,292 (85.1%) completed the trial. The number of mean inhalations per day was 2.14±1.15; the number of patients who had at least 1 as needed usage (PRN) inhalation per day was 843 (55.5%); the mean frequency of PRN use was 0.25±0.67 inhalations per day. The number of patients who overused for at least 1 day was 260 (17.1%). In particular, young patients, patients with limited physical activity, and patients with nocturnal symptoms demonstrated high frequency of overuse. The frequency of overuse during SMART was not high in Korean asthmatic patients and the asthma status of follow-up outpatients improved overall. However, there is a need for careful education targeted toward younger patients, patients with limited physical activity, and patients with nocturnal symptoms owing to their tendency to frequently overuse.

Real-Life Clinical Use of Symbicort® Maintenance and Reliever Therapy for Asthmatic Patients in Korea

The aim of this study was to examine the daily practice patterns of Symbicort® Maintenance and Reliever Therapy (SMART) in Korean asthmatic patients and to analyze clinical signs related to overuse. This study used an observational, multicenter, noninterventional, prospective, uncontrolled design for examining asthmatic patients prescribed SMART to assess the frequency and pattern of Symbicort® usage as a maintenance and reliever medication. The characteristics of patients showing signs of overuse (frequency of inhalation: 8 or more times per day) were also analyzed. Among the 1,518 patients analyzed, 1,292 (85.1%) completed the trial. The number of mean inhalations per day was 2.14±1.15; the number of patients who had at least 1 as needed usage (PRN) inhalation per day was 843 (55.5%); the mean frequency of PRN use was 0.25±0.67 inhalations per day. The number of patients who overused for at least 1 day was 260 (17.1%). In particular, young patients, patients with limited physical activity, and patients with nocturnal symptoms demonstrated high frequency of overuse. The frequency of overuse during SMART was not high in Korean asthmatic patients and the asthma status of follow-up outpatients improved overall. However, there is a need for careful education targeted toward younger patients, patients with limited physical activity, and patients with nocturnal symptoms owing to their tendency to frequently overuse.

A multicenter, cross-sectional, observational study of budesonide/formoterol maintenance and reliever therapy in real-world settings.

BACKGROUND: To assess the level of asthma control achieved with budesonide/formoterol in Chinese patients with asthma, based on the Global Initiative for Asthma (GINA) definition and Asthma Control Test (ACT) score. METHODS: This multicenter, cross-sectional study (NCT01785901) evaluated asthma control levels in Chinese patients receiving physician-prescribed budesonide/formoterol treatment. Adults with a diagnosis of asthma ≥6 months and receiving budesonide/formoterol treatment ≥3 months before screening were consecutively enrolled. Data including medical and medication history were collected using face-to-face questionnaires and physical examinations during a single visit. RESULTS: A total of 1483 asthma out-patients from 27 medical centers were enrolled; 217 (14.6%) were treated with budesonide/formoterol using a fixed-dose strategy and 1266 (85.4%) with the SMART (Symbicort® Maintenance And Reliever Therapy) strategy. According to GINA criteria, asthma was controlled in 58.6% (95% CI: 56.1%-61.1%) of patients and was either controlled or partly controlled in 94.1% (95% CI: 92.8%-95.3%) of patients. According to ACT score, asthma was completely controlled in 22.4% (95% CI: 20.3%-24.6%) of patients and was either completely or well controlled in 83.3% (95% CI: 81.4%-85.2%) of patients. Multivariate logistic regression analysis revealed that a >5-year history of asthma and an age of >50 years were factors associated with lower levels of asthma control. CONCLUSIONS: This study demonstrated high levels of asthma control (GINA: controlled and partly controlled and ACT: completely and well controlled) in Chinese patients with asthma treated with budesonide/formoterol. Greater age and a longer disease history were associated with lower levels of asthma control. TRIAL REGISTRATION: ClinicalTrials.govNCT01785901. Registered February 5, 2013.

Effect of treatment and intervention on COPD in stable phase with chronic obstructive pulmonary disease / 中国生化药物杂志

Objective To investigate the analysis of Symbicort in stable stage of chronic obstructive pulmonary disease treatment and intervention. Methods 80 patients with chronic obstructive pulmonary disease in stable period from June 2014-2016 year in May in our hospital were randomly divided into control group and experimental group, 40 cases in each group. The control group of patients with the use of simple Symbicort treatment and routine nursing care to patients, patients in the experimental group using Symbicort combined with Bailing Capsule for treatment, and the implementation of targeted nursing intervention measures, compare the effect of two groups of patients and nursing satisfaction. Results the clinical treatment of patients in the experimental group the total efficiency 95.0%, nursing satisfaction was 97.5%, the control of clinical patients in the treatment group the total effective rate was 80.0%, nursing satisfaction was 87.5%, the experimental group was significantly higher than the control group, the difference was statistically significant (P<0.05). Conclusion Chronic In the stable period of obstructive pulmonary disease, the combination of Xin Yi capsule combined with Bailing capsule can effectively improve the pulmonary function of patients and improve the clinical therapeutic effect, and is worthy of popularization and application in clinic.

Montelukast combined with symbicort analysis in severe asthma treatment and intervention effect / 中国生化药物杂志

Objective To investigate the effect of Montelukast Combined with Symbicort in severe asthma treatment and intervention. Methods The treatment according to different interventions will be January 2015 to January 2017 in our hospital 80 cases of severe asthma groups:control group with routine nursing intervention for a letter form treatment, the observation group with high quality nursing the intervention of montelukast Symbicort treatment; detailed records of patients in the two groups of experimental data, and the data for comparative analysis, to explore the combination of montelukast and Symbicort in severe asthma treatment and intervention effect. Results The high quality nursing intervention meng montelukast Symbicort (observation group) for the treatment of severe clinical the effect of nursing intervention in patients with asthma is better than conventional Symbicort (control group) clinical efficacy, clinical symptoms improved better than the control group, nursing satisfaction was higher than the control group, the difference was statistically significant (P< 0.05). Conclusion The high quality nursing intervention of patients with severe asthma montelukast Symbicort treatment effect significantly, can effectively improve the clinical symptoms of patients, nursing satisfaction is high, it is widely used in clinical treatment of patients with severe asthma intervention.

Efficacy of BiPAP combined with tiotropium bromide and COPD treatment and nursing intervention in moderate to severe stable phase / 中国生化药物杂志

Objective To evaluate the level of clinical treatment in severe stable double COPD noninvasive positive pressure ventilation (BiPAP) + tiotropium + Symbicort regimen effect. Methods 210 patients with moderate to severe COPD patients as the research object, divided into group I, group II, group III, 1 BiPAP + group with tiotropium bromide in the treatment scheme, group II Implementation of tiotropium + Symbicort treatment group enabled BiPAP + tiotropium + Symbicort. Results Group comparison indexes of pulmonary function level and lung function indexes were found in the three groups after treatment showed a rising trend comparison between groups after treatment, the levels of the indicators of lung function showed the most significant increases in group I, group II indexes of pulmonary function approximation. In group 6-MWD group with the longest distance difference index (P<0.05), group II and group I but the difference between does not have statistical significance Conclusion BiPAP + tiotropium bromide + Cr is an effective treatment for moderate and severe stable COPD, which is beneficial to improve the quality of life of patients.

Comparison of early effects of budesonide/formoterol maintenance and reliever therapy with fluticasone furoate/vilanterol for asthma patients requiring step-up from inhaled corticosteroid monotherapy.

BACKGROUND: If asthma patients fail to achieve symptom control using a medium dose of inhaled corticosteroid (ICS) alone, addition of a long-acting ß2 agonist (LABA) is the preferred treatment. Currently, there are several combinations of ICS/LABA that are available, each of which has a different property. Here, we aimed to compare the early effects of budesonide/formoterol (BUD/FM; Symbicort(®)) for maintenance and reliever therapy (SMART) with a fixed dose of fluticasone furoate/vilanterol (FF/VI; Relvar(®)). METHODS: Inadequately controlled asthma patients (defined as having an Asthma Control Questionnaire, 5-item version [ACQ5] score≥1.5) with a fractional exhaled nitric oxide (FeNO) value > 35 ppb, who had been treated with a medium dose of ICS alone, were enrolled. Patients were randomized into two groups and treated with two inhalations twice-daily of BUD/FM 160/4.5 µg plus as-needed BUD/FM (SMART group, n = 15) or one inhalation once-daily of FF/VI 100/25 µg plus as-needed procaterol (FF/VI group, n = 15) for 4 weeks. Outcomes including FeNO, impulse oscillometry (IOS) parameters and ACQ5 scores were measured at 0, 2 and 4 weeks. RESULTS: Both groups showed improvement in airway inflammation, pulmonary function and symptoms from baseline to 2 weeks. From 2 to 4 weeks, the SMART group exhibited continuous improvement in most measured parameters, whereas improvement in the FF/VI group seemed to reach a plateau transiently. Consequently, the SMART group showed significant improvement in the FeNO, IOS parameters (resonance frequency and integrated area of low frequency reactance) and ACQ5 score as compared with the FF/VI group at 4 weeks. CONCLUSION: As compared with the FF/VI group, the SMART group achieved a greater improvement in FeNO, small airway parameters regarding IOS and ACQ score, in patients with airway inflammation and uncontrolled symptoms treated with a medium dose of ICS alone. In this 4-week study, these two ICS/LABA combination therapies showed different treatment outcomes; they must be investigated further to clarify suitable patient characters and the long term efficacies for each combination.

The Influence pulmonary function and inflammatory factors of symbicort combined with ambroxol hydrochloride in the treatment of acute exacerbation of chronic obstructive pulmonary disease / 中国生化药物杂志

Objective To explore the influence pulmonary function and inflammatory factors of symbicort combined with ambroxol hydrochloride in the treatment of acute exacerbation of chronic obstructive pulmonary disease( AECOPD) .Methods 86 patients with AECOPD were divided into control group 43 cases and treatment group 43 cases according to the computer random number table method.The control group was given intravenous injection of ambroxol hydrochloride 60 mg/time, 2 times/day, and the treatment group was given inhalation of symbicort 2 inhaling/times, 3 times/day on the basis of the control group.After 7 day treatment, the clinical efficacy and adverse reactions of two groups were observed.The percentage of forced vital capacity ( FVC%) , percentage of forced expiratory volume of 1 seconds( FEV1 %) , percentage of mid expiratory flow predicted value( MMF%) , percentage of max volume predicted value(MVV%) were measured by pulmonary function test apparatus, and the value of FEV1%/FVC% was calculated.The levels of serum tumor necrosis factor alpha(TNF-α), c-reactive protein(CRP) and interleukin 6(IL-6) were detected by ELISA.Results The total effective rate of treatment group and control group were 93.02%(40/43) and 74.42%(32/43), the difference was statistically significant(P <0.05).After treatment the FVC%(2.58 ±0.25),FEV1%(1.87 ±0.15),MMF%(70.24 ±5.86)and MVV%(72.43 ±4.35) in treatment group were higher than the control group (2.21 ±0.27),(1.68 ±0.16),(63.14 ±5.68)and 65.12 ±4.16), the difference was statistically significant(P<0.05).The levels of serum TNF-α(13.87 ±4.12)μg/mL,CRP(9.14 ±3.76)mg/mLand IL-6(76.07 ±10.14)pg/mL in treatment group were lower than the control group (16.56 ±6.48)μg/mL,(12.46 ±3.89)mg/mL and(89.55 ±11.24)pg/mL,the difference was statistically significant(P<0.05).The adverse reactions were mainly for heartburn, nausea, vomiting and skin rashes in the control group,and the adverse reactions were mainly for heart palpitations, headache, nausea, rashes, vomiting in the treatment group, the incidences of adverse reactions 23.26%(10/43) in treatment group compared to control group 18.60%(8/43) was no statistically significant difference.Conclusion The symbicort combined with ambroxol hydrochloride in the treatment of AECOPD have clinical curative effect, can improve the patient's lung function, reduce inflammation, have less adverse reactions.It was worthy of clinical popularization and application.