布地奈德福莫特罗粉吸入剂治疗青少年变应性鼻炎合并哮喘患者的一氧化氮呼出气变化

目的观察布地奈德福莫特罗粉吸入剂治疗青少年变应性鼻炎合并哮喘的疗效。方法选取2012年1月-2013年12月45例青少年变应性鼻炎合并哮喘患者,完全随机化分组分成一般治疗组、布地奈德组、布地奈德福莫特罗组,每组15例,另设体检健康者15例为对照组。一般治疗组采用氨茶碱等一般治疗,布地奈德组在一般治疗基础上,给予布地奈德气雾剂100~200μg/(吸·次),2次/d;布地奈德福莫特罗组为一般治疗+布地奈德福莫特罗粉吸入剂,1吸/次,2次/d,其中吸入剂中含布地奈德含量160μg,福莫特罗4.5μg。连续用药4周后,停药4周进行一氧化氮(NO)呼出气检查。结果一般治疗组、布地奈德组、布地奈德福莫特罗组NO呼出气治疗前后自身相比,差异有统计学意义(P<0.05);3组治疗前后与对照组比较差异均有统计学意义(P<0.05);布地奈德组、布地奈德福莫特罗组NO呼出气治疗后相比差异有统计学意义(P<0.05)。结论布地奈德福莫特罗吸入剂治疗青少年变应性鼻炎合并哮喘患者在改善NO呼出气方面效果良好。     

布地奈德福莫特罗粉吸入剂治疗哮喘的疗效评价

目的 了解布地奈德福莫特罗粉吸入剂治疗哮喘的疗效.方法 通过治疗前后肺功能、ACT评分的比较判定布地奈德福莫特罗粉吸入剂的疗效.结果 哮喘患者使用布地奈德福莫特罗粉吸入剂后FEV1、FEEF25-75、ACT评分与治疗前相比差异有统计学意义(P＜0.001).结论 布地奈德福莫特罗粉吸入剂可有效的改善哮喘患者的肺功能指标及症状,达到治疗目的.     

布地奈德福莫特罗粉吸入剂联合噻托溴铵治疗AECOPD的效果观察

目的 探究布地奈德福莫特罗粉吸入剂与噻托溴铵(TB)用于慢阻肺急性加重期(AECOPD)的应用效果,为后续治疗AECOPD提供指导.方法 选取2018年5月～2020年5月于我院就诊的AECOPD患者80例,将采用TB治疗的40例患者资料纳入对照组,将采用布地奈德福莫特罗粉吸入剂+TB治疗的40例患者资料纳入观察组.对...     

复方甲氧那明联合布地奈德治疗咳嗽变异性哮喘临床研究

目的:探讨复方甲氧那明胶囊联合布地奈德福莫特罗粉吸入剂治疗咳嗽变异性哮喘患者的临床效果。方法:选取2016年6月～2018年5月我院收治的78例CVA患者为研究对象,依据随机数字表法分为对照组和实验组各39例。对照组予以布地奈德福莫特罗粉吸入剂治疗,实验组予以布地奈德福莫特罗粉吸入剂+复方甲氧那明胶囊治疗。比较两组临床疗效。结果:观察组治疗总有效率显著高于对照组(P0.05);治疗前,两组日间及夜间咳嗽症状评分以及FEV1%、PEF比较,差异无统计学意义(P0.05);治疗后,观察组日间及夜间咳嗽症状评分均低于对照组,FEV1%、PEF均高于对照组(P0.05);两组不良反应发生率比较,差异无统计学意义(P0.05)。结论:在对CVA患者予以布地奈德福莫特罗粉吸入剂治疗基础上,联合应用复方甲氧那明胶囊,能够显著缓解患者临床症状,提高肺功能,进一步提高治疗效果,且安全性较高,具有较高临床应用价值。     

布地奈德福莫特罗粉吸入剂对哮喘患者血清白细胞介素17水平的影响

目的:观察布地奈德福莫特罗粉吸入剂对支气管哮喘患者血清白细胞介素17(IL-17)水平的影响,探讨其改善支气管哮喘病情的可能机制。方法:2016年1月-2017年1月就诊于贵州省中医医院支气管哮喘门诊患者60例,分为治疗组42例,对照组18例,同时设52例健康人为健康对照组。治疗组予以布地奈德福莫特罗粉吸入剂。对照组予沙美特罗替卡松吸入,治疗时间均为90d。检测治疗组、对照组及健康对照组静脉血中IL-17的表达水平。结果:治疗组血清IL-17水平的中位数及四分位间距为20.14(9.57~47.26)g/L,对照组为4.28(2.36-10.82)g/L,2组比较差异有统计学意义(P0.01);治疗组轻、中、重度患者IL-17水平与病情呈正相关(P0.05);治疗组在吸入布地奈德福莫特罗前IL-17水平为16.27(7.06-29.52)g/L,治疗后为8.16(5.21-16.14)g/L,治疗组治疗前后比较有统计学意义(P0.01)。结论:支气管哮喘患者血清IL-17水平升高,布地奈德福莫特罗粉吸入剂可降低IL-17水平。     

布地奈德福莫特罗粉吸入剂治疗支气管哮喘的疗效观察

目的探讨布地奈德福莫特罗粉吸入剂治疗支气管哮喘的效果及对肺功能和生活质量的影响。方法选取收治的支气管哮喘患者68例作为研究对象,按照随机数字表法分为对照组和试验组各34例。对照组给予常规治疗,试验组在常规治疗基础上给予布地奈德福莫特罗粉吸入剂治疗,连续治疗3个月,比较两组临床疗效、肺功能、生活质量及不良反应发生率。结果试验组临床疗效优于对照组(P0.05);治疗前两组肺功能无明显差异(P0.05);治疗3个月后,两组肺功能指标均增高(P0.05),且试验组增高程度高于对照组(P0.05);试验组生活质量高于对照组(P0.05);两组不良反应发生率无明显差异(P0.05)。结论布地奈德福莫特罗粉吸入剂治疗支气管哮喘疗效明显,可有效改善肺功能,提高患者生活质量且安全性高。     

氨茶碱片联合布地奈德福莫特罗粉吸入剂、噻托溴铵治疗 稳定期 COPD 患者的疗效评价

目的:探讨氨茶碱片联合布地奈德福莫特罗粉吸入剂、噻托溴铵治疗稳定期慢性阻塞性肺疾病患者的疗效。方法:选取122例稳定期慢性阻塞性肺疾病患者,按照随机数字表法分为观察组和对照组各61例。对照组采用布地奈德福莫特罗粉吸入剂、噻托溴铵治疗,观察组采用氨茶碱片联合布地奈德福莫特罗粉吸入剂、噻托溴铵治疗。比较两组疗效、治疗前后肺功能指标(用力肺活量、第1秒用力呼气容积)、运动耐力、血清环氧化酶-2、转化生长因子-β1水平。结果:观察组总有效率93.44%高于对照组78.69%(P<0.05);治疗后观察组用力肺活量、第1秒用力呼气容积高于对照组,6 min步行距离长于对照组(P<0.05);治疗后观察组血清环氧化酶-2、转化生长因子-β1水平低于对照组(P<0.05)。结论:氨茶碱片联合布地奈德福莫特罗粉吸入剂、噻托溴铵治疗稳定期慢性阻塞性肺疾病患者效果显著,可有效提高肺功能及运动耐力,缓解炎症反应。     

布地奈德福莫特罗粉吸人剂联合孟鲁司特治疗儿童哮喘36例

目的:观察布地奈德福莫特罗粉吸入剂联合孟鲁司特对儿童哮喘的治疗效果.方法:将2007年2月20日至2008年8月20日广东省普宁市华侨医院住院或门诊临床诊断为儿童哮喘的患儿73例分为两组,A组36例,用布地奈德福莫特罗粉吸入剂1吸,每天2次,加孟鲁司特5 mg每晚1次×3个月治疗.B组37例,单用吸入布地奈德福莫特罗粉吸入剂1吸,每天2次,观察1周后两组患儿咳嗽,气喘症状及肺部罗音情况,3个月时肺功能第1利用力呼气容积(FEV1)指标及1年随访复发情况.结果:1周后A组显效及总有效率优于B组(P＜0.05),治疗3个月FEV1有明显差异,随访1年复发率A组(2/30)与B组(7/31)无明显差异.结论:布地奈德福莫特罗粉吸入剂联合孟鲁司特治疗哮喘疗效优于单纯应用信必可都布地奈德福莫特罗粉吸入剂,但不降低复发率.     

噻托溴铵粉雾剂联合布地奈德福莫特罗粉吸入剂对慢性阻塞性肺疾病肺功能的影响

目的 探索分析针对阻塞性肺疾病患者应用噻托溴铵粉雾剂联合布地奈德福莫特罗粉吸入剂实施治疗对其肺功能的作用和影响.方法 将我院2019年1月至10月期间收治的慢性阻塞性肺疾病患者80例作为研究对象并随机分组,对照组40例均接受布地奈德福莫特罗粉吸入剂治疗,研究组40例均接受噻托溴铵粉雾剂联合布地奈德福莫特罗粉吸入剂治疗....     

布地奈德混悬液雾化治疗与布地奈德福莫特罗粉吸入剂吸入治疗对中重度支气管哮喘患者的疗效比较

目的比较布地奈德混悬液雾化治疗与布地奈德福莫特罗粉吸入剂吸入治疗对中重度支气管哮喘患者的临床疗效。方法按照随机数字表法将中山市人民医院2019年1月至2019年12月收治的78例中、重度支气管哮喘患者分为观察组与对照组,每组39例。观察组采用布地奈德福莫特罗粉吸入剂吸入治疗,对照组采用布地奈德混悬液雾化治疗,评价治疗4周后哮喘控制情况,比较两组患者的肺功能指标、支气管舒张试验转阴率,观察并记录两组患者治疗后发生的不良反应。结果观察组哮喘的控制良好率为79.49%(31/39),显著高于对照组[56.41%(22/39)],差异有统计学意义(P 0.05)。治疗前,两组肺功能各项指标比较差异未见统计学意义(P 0.05);治疗后,两组第一秒用力呼气容积、第一秒用力呼气容积占预计值百分比、一秒率、最大呼气流量均升高,且观察组值均高于对照组(P 0.05)。治疗后,观察组支气管舒张试验转阴率为74.36%(29/39),高于对照组[51.28%(20/39)],差异有统计学意义(P 0.05)。观察组不良反应发生率为7.69%(3/39);对照组为2.56%(1/39),两组比较差异未见统计学意义(P0.05),所有患者均未出现严重不良事件。结论布地奈德福莫特罗粉吸入剂吸入治疗较布地奈德混悬液雾化治疗更有利于支气管舒张试验的转阴,前者对控制哮喘、改善肺功能的效果更好。     

布地奈德福莫特罗粉吸入治疗成人支气管哮喘的疗效观察

目的比较布地奈德福莫特罗粉复方制剂与沙丁胺醇气雾剂联合布地奈德气雾剂吸入治疗成人中重度持续性支气管哮喘的临床疗效和安全性。方法采用随机、开放、平行对照试验,80例18～70岁哮喘患者按随机数字表法分为试验组（43例,吸入布地奈德福莫特罗粉复方制剂每吸160μg／4．5彬吸,2吸,每天2次）和对照组（37例,吸入布地奈德200μg／吸,2吸,每天2次＋沙丁胺醇100μg／吸,2吸,每天4次）,观察临床症状、肺功能变化和不良事件发生情况。结果两组药物都可改善患者的哮喘症状和减少按需使用缓解药物的情况,但试验组改善更快（P〈0．05）。肺功能方面,两组患者第1秒用力呼气量（FEV1）都有所提高,但两组间无显著差异;试验组对晨间呼气峰流速（PEFam）、夜间呼气峰流速（PEFpm）提高显著快于对照组（P〈0．05）。两组不良事件的发生率无显著差异（P〉0．05）。结论布地奈德福莫特罗粉复方制剂和沙丁胺醇气雾剂联合布地奈德气雾剂用于治疗持续性支气管哮喘都具有良好的疗效和安全性。但布地奈德福莫特罗粉复方制剂改善持续性支气管哮喘效果更快、使用更方便。     

Budesonide/formoterol in a single inhaler (Symbicort) reduces healthcare costs compared with separate inhalers in the treatment of asthma over 12 months

This open, multinational, randomised, parallel-group, six-month extension conducted in the Swedish centres of a previous six-month study compared the costs of a total of 12 months of treatment with budesonide/formoterol in a single inhaler with budesonide plus formoterol separate inhalers in 320 adults with asthma. Patients received budesonide/formoterol (Symbicort Turbuhaler) 160/4.5 mg delivered doses, two inhalations b.i.d., or corresponding doses of budesonide (Pulmicort Turbuhaler) plus formoterol (Oxis Turbuhaler). Direct costs and indirect costs were estimated. Budesonide/formoterol treatment was associated with reduced healthcare service utilisation and statistically significant reductions in direct (SEK1595, p=0.0004) and total costs (SEK1884, p=0.043) per person per year compared with budesonide plus formoterol. Budesonide/formoterol reduced the average annual emergency room admission cost per person by SEK489.7 (31% of direct cost reduction) and physician costs by SEK235.4 (15%).The direct cost of study, relief and other medication was reduced by SEK893.8 (47% of total reduction). There were no statistically significant differences in efficacy and safety parameters following treatment with budesonide/formoterol from single or separate inhalers, other than a significantly lower proportion of withdrawals with the single inhaler (9.2% vs 19.4%, p=0.008). In summary, budesonide/formoterol treatment from a single inhaler reduced 12-month treatment costs compared with separate inhalers, while maintaining at least as good control of asthma.     

Symbicort Turbuhaler: a new concept in asthma management

Symbicort is a novel asthma product containing both budesonide and formoterol in a single inhaler, Turbuhaler. Budesonide is a corticosteroid that treats underlying airway inflammation in asthma; formoterol is a rapid- and long-acting beta2-agonist that prevents and reverses airway obstruction. Budesonide and formoterol therefore have complementary effects, treating two different components of asthma. Clinical studies have shown that Symbicort is more effective in the treatment of asthma than double-dose corticosteroid, and clinical experience to date indicates that Symbicort is at least as effective and well tolerated as budesonide and formoterol given in separate inhalers. Symbicort has a fast onset of effect, which may help patients feel more in control of their condition and improve adherence to their medication, and a long duration of effect that allows twice-daily or even once-daily dosing during periods of good control. More convenient treatment represents another important benefit for patients with asthma, as ease of use can also result in improved adherence, leading to better disease control.     

Twelve-week, randomized, placebo-controlled, multicenter study of the efficacy and tolerability of budesonide and formoterol in one metered-dose inhaler compared with budesonide alone and formoterol alone in adolescents and adults with asthma

BACKGROUND: The addition of the long-acting beta(2)-adrenergic agonist formoterol to low- to moderate-dose budesonide has shown clinical efficacy in patients with persistent asthma. Combination therapy with budesonide/formoterol in 1 pressurized metered-dose inhaler (pMDI) has been found to have greater efficacy than its monocomponents in patients with moderate to severe persistent asthma, but it has not been assessed in patients with mild to moderate persistent asthma. OBJECTIVE: The aim of this study was to compare the efficacy and tolerability of budesonide and formoterol delivered via 1 pMDI (budesonide/formoterol pMDI), budesonide pMDI, formoterol dry powder inhaler (DPI), and placebo. METHODS: This 12-week, multicenter, double-blind, randomized, placebo-controlled, double-dummy study was conducted at 56 centers across the United States. Patients aged > or =12 years with mild to moderate persistent asthma treated with inhaled corticosteroids (ICSs) for > or =4 weeks before screening and who had a forced expiratory volume in 1 second (FEV(1)) of > or =60% to < or =90% of predicted normal at screening were eligible. After 2 weeks (current asthma therapy discontinued), patients received twice-daily budesonide/formoterol pMDI 80/4.5 microg x 2 inhalations (160/9 microg), budesonide pMDI 80 microg x 2 inhalations (160 microg), formoterol DPI 4.5 microg x 2 inhalations (9 microg), or placebo. The coprimary efficacy variables were changes from baseline in morning predose FEV(1) and 12-hour mean FEV(1) (from serial spirometry) after administration of the morning dose of study medication. Tolerability was assessed based on adverse events (AEs); routine laboratory assessments; electrocardiography; 24-hour Holter monitor assessments; and physical examinations, including vital signs (eg, systolic and diastolic blood pressure and heart rate). AEs were recorded manually by the patient in paper notebooks and reviewed at each clinic visit by the investigator and during a final follow-up phone call. RESULTS: A total of 480 patients were randomized (299 females, 181 males; mean age, 36 years; mean FEV(1), 2.4 L; budesonide/formoterol pMDI, 123 patients; budesonide pMDI, 121; formoterol DPI, 114; placebo, 122). At end of treatment, the mean increases from baseline in predose FEV(1) were greater with budesonide/formoterol pMDI versus budesonide pMDI, formoterol DPI, and placebo (0.37 vs 0.23, 0.17, and 0.03 L, respectively; all, P<0.005). 0.005). After administration of the first dose and at weeks 2 and 12, mean increases in 12-hour mean FEV(1) were significantly greater with budesonide/formoterol pMDI (0.41, 0.47, and 0.50 L, respectively) versus budesonide pMDI (0.17, 0.30, and 0.32 L) and placebo (0.15, 0.12, and 0.12 L) (all, P < 0.001). Fewer patients receiving budesonide/formoterol pMDI met criteria for (18.7%; P < 0.001) or withdrew because of (7.3%; P < or = 0.010) worsening asthma versus formoterol DPI (42.1% and 18.4%, respectively) and placebo (56.6% and 32.8%); results were similar between budesonide pMDI (21.5% and 6.6%, respectively) and budesonide/formoterol pMDI. Three patients experienced serious AEs; none was considered related to study medication. The proportions of withdrawals due to worsening asthma were not significantly different between the budesonide/formoterol pMDI and budesonide pMDI groups. CONCLUSIONS: In this population of adults and adolescents with mild to moderate persistent asthma previously treated with ICSs, twice-daily budesonide/formoterol pMDI was associated with significantly increased pulmonary function versus its monocomponents. All study drugs were generally well tolerated.     

Therapeutic comparison of a new budesonide/formoterol pMDI with budesonide pMDI and budesonide/formoterol DPI in asthma

BACKGROUND: Budesonide/formoterol is an effective treatment for both asthma and chronic obstructive pulmonary disease. This study compared the efficacy and safety of a novel hydrofluoroalkane (HFA) pressurised metered-dose inhaler (pMDI) formulation of budesonide/formoterol with that of budesonide pMDI and budesonide/formoterol dry-powder inhaler (DPI; Turbuhaler). METHODS: This was a 12-week, multinational, randomised, double-blind, double-dummy study involving patients aged > or = 12 years with asthma. All patients had a forced expiratory volume in 1 s of 50-90% predicted normal and were inadequately controlled on inhaled corticosteroids (500-1600 microg/day) alone. Following a 2-week run-in, during which they received their usual medication, patients were randomised (two inhalations twice daily) to budesonide pMDI 200 microg, budesonide/formoterol DPI 160/4.5 microg or budesonide/formoterol pMDI 160/4.5 microg. The primary efficacy end-point was change from baseline in morning peak expiratory flow (PEF). RESULTS: In total, 680 patients were randomised, of whom 668 were included in the primary analysis. Therapeutically equivalent increases in morning PEF were observed with budesonide/formoterol pMDI (29.3 l/min) and budesonide/formoterol DPI (32.0 l/min) (95% confidence interval: -10.4 to 4.9; p = 0.48). The increase in morning PEF with budesonide/formoterol pMDI was significantly higher than with budesonide pMDI (+28.7 l/min; p < 0.001). Similar improvements with budesonide/formoterol pMDI vs. budesonide pMDI were seen for all secondary efficacy end-points. Both combination treatments were similarly well tolerated. CONCLUSIONS: Budesonide/formoterol, administered via the HFA pMDI or DPI, is an effective and well-tolerated treatment for adult and adolescent patients with asthma, with both devices being therapeutically equivalent.     

Inhaled corticosteroids or long-acting β-agonists alone or in fixed-dose combinations in asthma treatment: A systematic review of fluticasone/budesonide and formoterol/salmeterol

Background: Inhaled corticosteroids (ICSs) and longacting inhaled β₂-agonists (LABAs) are recommended treatment options for asthma.Objective: This review compares the clinical effectiveness and tolerability of the ICSs fluticasone propionate and budesonide and the LABAs formoterol fumarate and salmeterol xinafoate administered alone or in combination.Methods: A systematic review of the clinical studies available on MEDLINE (database period, 1950-September 2009) was conducted to assess English-language randomized controlled trials in children and adults with asthma. Treatment outcomes included lung function, symptom-free days (SFDs), use of rescue/reliever medications, asthma exacerbations, and tolerability profile.Results: Use of fluticasone was associated with significantly greater improvement in lung function and better asthma symptom control than budesonide. Similarly, formoterol was associated with significantly greater improvement in lung function and better asthma symptom control (as measured by less rescue medication use and more SFDs) compared with salmeterol. Single inhaler combination regimens (budesonide/ formoterol and fluticasone/salmeterol) were frequently more effective in improving all treatment outcomes than either monotherapy alone. Across all comparisons, a review of studies in adults and children did not find statistically significant differences in outcomes between the ICS and LABA therapies considered in this research. In general, no differences in tolerability profiles were reported between the ICS and LABA options, although the risk for growth retardation was lower with fluticasone than budesonide and with budesonide/formoterol than with budesonide monotherapy.Conclusions: In this systematic review, fluticasone and formoterol appear to provide improved therapeutic benefits versus budesonide and salmeterol, respectively. Both fluticasone/salmeterol and budesonide/ formoterol combination therapies appeared to be associated with greater improvements in outcomes measures than the corresponding ICS and LABA monotherapies.     

孟鲁司特钠联合布地奈德福莫特罗粉吸入剂治疗支气管哮喘的临床效果及其对患者炎性因子水平、肺功能、免疫功能的影响

目的探讨孟鲁司特钠联合布地奈德福莫特罗粉吸入剂治疗支气管哮喘的临床效果及其对患者炎性因子水平、肺功能、免疫功能的影响。方法将150例支气管哮喘患者根据治疗方法分为对照组和试验组,各75例。对照组在常规治疗基础上使用布地奈德福莫特罗粉吸入剂,试验组在对照组的基础上再联合孟鲁司特钠片进行治疗。比较两组的治疗效果、炎症因子水平、免疫功能、肺功能及不良反应发生情况。结果试验组的治疗总有效率高于对照组(P<0.05);治疗后,两组的TNF-α、IL-5、IgE水平均低于治疗前,IgA和IgG水平、PEF、FEV1、FEV1/FVC均高于治疗前,且试验组优于对照组(P<0.05);两组的不良反应总发生率无显著差异(P>0.05)。结论孟鲁司特钠联合布地奈德福莫特罗粉吸入剂治疗支气管哮喘患者的临床疗效显著,可以有效降低机体的炎症因子水平,改善肺功能和免疫功能,同时不会增加不良反应的发生率,值得临床推广应用。     

Budesonide/formoterol maintenance and reliever therapy. A new treatment approach for adult patients with asthma]

BACKGROUND: An inhaled corticosteroid (ICS) or an ICS/long-acting beta(2)-agonist (LABA) combination plus short-acting beta(2)-agonist (SABA) as needed for symptom relief is recommended for persistent asthma. Additionally, budesonide/formoterol maintenance and reliever therapy (Symbicort) SMART, AstraZeneca, Sweden) has been approved for adults in the European Union. This option is well tolerated and offers greater reductions in asthma exacerbations together with similar improvements in daily symptom control, at a lower overall steroid load, compared with fixed-dose ICS/LABA plus SABA. METHODS: Two large clinical trials investigated the use of budesonide/formoterol as maintenance and reliever compared with medium or high doses of an ICS/LABA combination as controller plus SABA as reliever in adults (aged >or= 18 years). COMPASS was a 6-month, double-blind, randomized trial, while COSMOS was a 1-year, dose titration study which reflected routine clinical practice. RESULTS: Among adults, the studies confirmed a 21-39% reduction in severe exacerbations in patients treated with budesonide/formoterol maintenance and reliever therapy compared with titrated salmeterol/fluticasone plus SABA (COSMOS) or fixed higher budesonide/formoterol or salmeterol/fluticasone plus SABA (COMPASS), respectively. Similar levels of daily asthma control were achieved with budesonide/formoterol maintenance and reliever therapy at a significantly lower overall steroid load compared with salmeterol/fluticasone or budesonide/formoterol plus SABA. Budesonide/formoterol maintenance and reliever therapy was as well tolerated as combination therapies. CONCLUSION: In adult patients, budesonide/formoterol maintenance and reliever therapy is a safe and simplified approach to asthma management, using a single inhaler, which reduces severe exacerbations and maintains similar daily asthma control at a lower drug load compared with the traditional strategy of ICS/LABA plus SABA.     

Bronchodilation of formoterol administered with budesonide: device and formulation effects

BACKGROUND: Previous single-dose crossover studies have established therapeutic equivalence of formoterol when administered at the same nominal dose via a dry powder inhaler (DPI) or pressurized hydrofluoroalkane (HFA) metered-dose inhaler (pMDI). Demonstration of equivalent bronchodilation for formoterol administered as formoterol DPI or combined with budesonide in one pMDI (budesonide/formoterol pMDI) would indicate that the greater clinical efficacy of the budesonide/formoterol pMDI combination is due to the budesonide contribution and not to differences in formoterol formulation or delivery device. OBJECTIVE: To determine whether the formoterol-related bronchodilatory effects of formoterol DPI and budesonide/formoterol pMDI are similar, despite formoterol formulation and delivery device differences. METHODS: This was a multicenter, open-label, five-period crossover study conducted in 201 adult patients with stable asthma. The study included a screening visit, a 7- to 14-day run-in period, during which patients were treated with budesonide pMDI (80 microg per inhalation, two inhalations twice daily), and a randomized treatment period that included five single-day treatment periods, during which patients received single-dose crossover treatments, each of which was separated by a 3- to 14-day washout period. Patients were randomized to five of seven single-dose treatments (one, two, or four inhalations of budesonide/formoterol pMDI 80/4.5 microg; four inhalations of budesonide pMDI 80 microg plus one, two, or four inhalations of formoterol DPI 4.5 microg; or four inhalations of budesonide pMDI 80 microg alone). At clinic visits, the budesonide pMDI dose was coordinated with the budesonide dose delivered via the budesonide/formoterol pMDI such that all patients received a 320-microg dose of budesonide. The primary variable was average forced expiratory volume in 1 s (FEV1) from the area under the curve divided by time from 12-h serial spirometry. RESULTS: Average 12-h FEV1 values were similar, regardless of delivery device, among treatments with the same nominal formoterol doses and dose-ordered within each device; mean FEV1 values were significantly higher for treatments containing formoterol versus budesonide alone. The formoterol dose potency ratio for budesonide/formoterol pMDI:formoterol DPI (0.97; 95% confidence interval, 0.73-1.27) demonstrated clinical equivalence in bronchodilation at the same formoterol dose. CONCLUSION: Budesonide/formoterol pMDI affords equivalent formoterol-related bronchodilatory effects versus formoterol DPI at formoterol doses of 4.5, 9, and 18 microg, indicating that practitioners can expect and patients will experience similar bronchodilation from the same dose of formoterol whether it is delivered as monotherapy via a DPI or as combination therapy with budesonide via one pMDI.     

Formoterol 12 microg BID administered via single-dose dry powder inhaler in adults with asthma suboptimally controlled with salmeterol or on-demand salbutamol: a multicenter,randomized, open-label,parallel-group study

BACKGROUND: Although salmeterol and formoterol are both long-acting beta(2) adrenergic receptor agonist bronchodilators, there are distinct differences between them that could translate into differences in clinical response in some patients. OBJECTIVE: The goal of this study was to examine the efficacy of formoterol in patients with moderate to severe persistent asthma that was suboptimally controlled with an inhaled corticosteroid (ICS) combined with on-demand salbutamol (albuterol in the United States) with or without salmeterol. METHODS: This multicenter, 4-week, randomized, open-label, parallel-group study included adult patients (age >/=18 years) with suboptimally controlled asthma (mean salbutamol use, >/=2 puffs/d via pressurized metered-dose inhaler [100 microg/puff]). Patients were randomized in a 2:1 ratio to receive formoterol 12 microg BID via single-dose dry powder inhaler plus on-demand salbutamol or to continue their existing treatment with either on-demand salbutamol alone or salmeterol 50 microg BID via multidose dry powder inhaler plus on-demand salbutamol. ICS regimens were unchanged during the trial. The primary efficacy variable was evening predose peak expiratory flow (PEF). Secondary variables included further measures of asthma symptom control.RESULTS: A total of 6239 adult patients entered the study; data from 6155 patients were available for analysis. Patients who were switched from salmeterol to formoterol reported a significant increase in mean (SD) evening predose PEF compared with patients who continued their existing treatment (402.9 [112.1] vs 385.5 [107.5] Umin, respectively; P < 0.001). Similarly, patients who were switched from on-demand salbutamol alone to formoterol plus on-demand salbutamol reported a significant increase in mean evening predose PEF compared with those who continued treatment with on-demand salbutamol alone (409.3 [105.6] vs 385.0 [105.3] L/min, respectively; P < 0.001). The results for the secondary efficacy measures mirrored the significant improvements seen in patients switched to formoterol compared with those who continued to receive on-demand salbutamol alone or salmeterol plus on-demand salbutamol. CONCLUSION: In this study, formoterol significantly improved lung function and control of asthma symptoms and decreased use of rescue medication in patients whose asthma had been suboptimally controlled with an ICS in combination with on-demand salbutamol with or without salmeterol.