雾化吸入布地奈德与沙丁胺醇治疗支气管哮喘急性发作对HMGB1的影响及治疗效果评价

目的探究布地奈德联合沙丁胺醇雾化吸入对支气管哮喘急性发作患者血清中HMGB1的影响,并评价临床治疗效果。方法分析2013年1月~2014年12月我院收治的支气管哮喘急性发作期患者的临床资料,随机分为两组,观察组患者在采用常规治疗方案外,增加布地奈德联合沙丁胺醇雾化吸入治疗,对照组患者采用常规方法治疗。结果两组研究对象治疗后肺功能指标FEV_1、FVC、PEF水平明显高于治疗前指标水平,差异具有统计学意义(P0.05);治疗后观察组患者FEV_1、FVC、PEF水平高于对照组患者治疗后的指标水平,差异具有统计学意义(P0.05);治疗后观察组患者血清中血清中TNF-α、CRP、HMGB1水平明显低于对照组,差异具有统计学意义(P0.05);观察组患者HMGB1与FEV_1(r=-0.522,P0.001)呈显著负相关,与CRP(r=0.365,P=0.009)呈现正相关关系;观察组患者治疗总有效率为94%,对照组总有效率为79.55%,观察组治疗总有效率明显高于对照组,差异具有统计学意义(P0.05)。结论通过布地奈德联合沙丁胺醇联合雾化吸入治疗支气管哮喘急性发作的患者治疗效果较好,临床上可以大力推广。     

哮喘患者小气道功能与气道高反应性的关系探讨

目的探讨哮喘患者小气道功能与气道高反应性的关系。方法选取可疑哮喘患者164例进行肺通气功能测定及支气管激发试验(BPT),依据激发试验结果分为AHR阴性组(n=34)、轻度组(n=53)、中度组(n=43)及重度组(n=34),收集临床资料,检测FVC%pred、FEV_1%pred、FEV_1/FVC、PEF%pred、FEF25%pred、FEF50%pred、FEF75%pred、FEF25-75%pred水平,分析患者基础小气道功能与气道高反应性之间的相关性,利用受试者工作特征(ROC)曲线分析小气道功能指标在预测气道反应性中的价值。结果 (1)基础FVC%pred、FEV_1%pred、FEV_1/FVC、PEF%pred、FEF25%pred、FEF50%pred、FEF75%pred、FEF25-75%pred从AHR阴性组、轻度组、中度组到重度组,数值依次递减,差异均有统计学意义(P0.05)。(2)小气道功能障碍的发生率从AHR阴性组、轻度组、中度组到重度组依次递增,差异有统计学意义(P0.001)。(3)以基础FEF25%pred、FEF50%pred、FEF75%pred、FEF25-75%pred作ROC曲线,曲线下面积(AUC)分别为0.80、0.873、0.833、0.879,均大于0.5,差异有统计学意义(P0.001)。结论哮喘患者基础小气道功能指标与气道高反应性密切相关,且对气道反应程度较低或无反应状态的患者有一定的预测价值。     

噻托溴铵联合布地奈德治疗轻中度支气管哮喘的疗效观察

目的观察噻托溴铵联合布地奈德治疗轻中度支气管哮喘的临床疗效。方法选择我院2011年11月—2012年12月诊治的轻中度支气管哮喘患者60例,随机分为观察组和对照组,每组30例。对照组患者吸入布地奈德,观察组吸入布地奈德+噻托溴铵。检测两组患者治疗前及治疗后8周第一秒用力呼气容积(FEV1)、呼气峰流速(PEF);记录两组患者治疗后8周支气管哮喘急性发作次数及治疗期间不良反应情况。结果两组患者治疗前FEV1及PEF比较,差异均无统计学意义(P0.05);两组患者治疗后FEV1及PEF高于治疗前,且观察组患者治疗后FEV1及PEF高于对照组(P0.05)。治疗组患者治疗后8周支气管哮喘急性发作次数为(2.3±0.2)次,低于对照组的(9.2±0.3)次(P0.05)。观察组患者治疗期间出现口干2例,对照组患者治疗期间出现失眠1例,两组患者不良反应发生率比较,差异无统计学意义(P0.05)。结论噻托溴铵联合布地奈德治疗轻中度支气管哮喘疗效确切,可有效改善患者肺功能,减少支气管哮喘急性发作次数。     

心理干预对地震灾害所致创伤后应激障碍并支气管哮喘急性发作期患者的影响

目的 探索心理干预对地震灾害所致创伤后应激障碍合并支气管哮喘急性发作期患者的影响.方法 将来自地震灾区的符合美国精神病协会制定的创伤后应激障碍诊断标准的支气管哮喘急性发作期患者40例分为对照组及干预组,分别给予支气管哮喘常规治疗、支气管哮喘常规治疗联合心理干预,比较两组PTSD检查量表(PCL-C)、ACQ5、FEV1%pred、PEF%pred、外周血嗜酸粒细胞(EOS)的变化;分析干预组中PCL-C与ACQ5、FEV1%pred、PEF%pred、EOS之间的关系.结果 干预组的PCL-C、ACQ5、FEV1%pred、PEF%pred较之对照组有明显改善,两组之间的差异有统计学意义(P＜0.05);但EOS改善不明显,两组之间的差异无统计学意义(P＞0.05);干预组中PCL-C与ACQ5呈正相关(r=0.61,P＜0.05),与FEV1%pred、PEF%pred呈负相关(r值分别为-0.53、-0.57),与EOS无直线相关关系(P＞0.05).结论 用心理干预联合支气管哮喘常规治疗的方法治疗地震灾害所致PTSD并支气管哮喘急性发作期患者的疗效优于单纯的常规治疗,但对EOS改善作用不大.     

氨茶碱对哮喘呼吸道重塑大鼠支气管组织中Bcl-2及Bax蛋白含量的影响

目的 观察氨茶碱对支气管哮喘呼吸道重塑大鼠呼吸道形态学及气管周围组织中凋亡相关蛋白Bcl-2及Bax含量的影响.方法 SD大鼠随机分为正常组、模型组、治疗组,每组8只,除正常组外以卵蛋白致敏并吸入激发法制备大鼠哮喘模型,治疗组、模型组从第1次哮喘激发开始(造模第15天)分别给予氨茶碱0.035 g·kg-1·d-1、生理盐水2 ml/d灌胃给药,用药4 w后处死大鼠,取肺组织HE染色,病理图像分析仪测量支气管壁面积、支气管平滑肌面积,采用免疫组化法测定支气管上皮及支气管壁周围组织中凋亡相关蛋白Bcl-2及Bax含量.结果 与正常组比较,模型组大鼠支气管壁面积、平滑肌面积明显增加(t=5.13,P=0.00,t=2.85,P=0.00),支气管上皮中凋亡相关蛋白Bcl-2及支气管壁周围组织中Bax含量均明显增加(t=52.4,P=0.00,t=61.0,P=0.00),治疗组大鼠支气管壁面积、平滑肌面积较模型组显著降低(t=2.77,P=0.00,t=1.26,P=0.01),支气管上皮中Bcl-2含量及支气管周围组织中Bax含量均显著增加(t=28,P=0.009,t=36.5,P=0.01).结论 氨茶碱可通过提高支气管上皮中Bcl-2及支气管周围组织中Bax含量抑制哮喘大鼠气管壁、平滑肌增厚,从而抑制支气管哮喘大鼠气管重塑.     

支气管哮喘在卡介菌多糖核酸治疗后IFN-γ、IL-4、IL-5的变化

目的　探讨支气管哮喘患者应用卡介菌多糖核酸 (PNBCG)注射液治疗之后 IFN-γ、IL - 4、IL - 5的血清值的变化。方法　 110例哮喘患者被随机分为卡介菌多糖核酸组、糖皮质激素治疗组和常规治疗组。卡组患者注射PNBCG注射液 0 .5 mg/ d× 90 d。结果　卡组治疗后 IFN-γ的血清值明显增高 ,是治疗前的 1.919倍 (95 % CI:2 82 .19;4 8.72 ) (p<0 .0 1)。 IL - 4、IL - 5的血清值明显降低 ,分别是治疗前的 0 .4 4倍 (95 % CI:1.4 2 ;0 .31) (p<0 .0 1)和0 .5 3倍 (95 % CI:2 1.12 ;- 4 .71) (p<0 .0 1)。结论　支气管哮喘患者在用 PNBCG后 IFN-γ的血清值升高 ,IL - 4、IL -5的血清值降低可能是哮喘患者病情转轻的原因     

支气管哮喘患儿诱导痰嗜酸粒细胞与肺功能及FeNO浓度的关系

目的探讨支气管哮喘(哮喘)患儿诱导痰嗜酸粒细胞(EOS)与肺功能及呼出气一氧化氮(FeNO)浓度的关系。方法回顾分析了2016年10月至2018年12月在海南省妇女儿童医学中心儿科就诊的哮喘患儿共113例的病例资料,纳入观察组;将同期在海南省妇女儿童医学中心体检的50例健康儿童纳入对照组。分别检测2组受试者的诱导痰EOS、第1秒用力呼气容积占预计值百分比(FEV1%pred)以及FeNO水平并进行相关分析。结果观察组患儿诱导痰EOS和FeNO水平显著高于对照组(t=11.921、17.081,P值均<0.05),而其FEV1%pred较对照组差,差异有统计学意义(t=18.673,P<0.05)。针对观察组患儿的相关数据进行分析,发现FeNO与痰EOS水平呈正相关(r=0.265,P=0.005)。肺功能FEV1%pred与痰EOS水平无明显相关性(r=0.158,P=0.093)。结论哮喘患儿诱导痰EOS水平与FeNO呈正相关,但与肺功能无明显相关性。     

两种吸入剂对支气管哮喘患者肾上腺皮质功能、糖脂代谢的影响

目的探讨长期应用布地奈德福莫特罗吸入剂(160μg/4.5μg)对支气管哮喘患者的控制作用及对肾上腺皮质功能、糖脂代谢的影响。方法将78例支气管哮喘患者随机分成治疗组和对照组,治疗组给予布地奈德福莫特罗吸入剂(160μg/4.5μg),每日两次,对照组按需应用沙丁胺醇吸入剂,口服茶碱缓释片。观察周期为一年。两组患者在治疗前1天(T0)、一个月(T1)、三个月(T3)、六个月(T6)、12个月(T12),分别给予哮喘控制测试(asthma control test,ACT)评分,呼气峰流速(peak expiratory flow,PEF)日变异率检查,分别抽血测皮质醇、促肾上腺素皮质激素(ACTH),空腹血糖(FPG)、糖化血红蛋白(HbA1c)、甘油三酯、总胆固醇。结果治疗组患者ACT评分高于对照组(P0.05),治疗组患者PEF日变异率小于对照组(P0.05)。治疗组与对照组皮质醇、ACTH、FPG、HbA1c、总胆固醇、甘油三酯之间的差异无统计学意义(P0.05)。结论布地奈德福莫特罗吸入剂对支气管哮喘患者的控制有良好作用,长期应用对患者的肾上腺皮质功能、糖脂代谢无不良影响。     

老年患者哮喘长期控制不佳应用雾化吸入糖皮质激素的疗效

目的 评价长期雾化吸入糖皮质激素及支气管扩张剂治疗对长期控制不佳老年哮喘患者的疗效及安全性. 方法 采用前瞻性、随机对照的研究方法.将63例规律吸入激素或加用其他哮喘长期控制药物治疗3个月以上但仍处于哮喘中度或重度持续的老年哮喘患者,随机分为雾化吸入治疗组(31例)和常规吸入治疗组(32例).分别采用布地奈德混悬液1 mg及沙丁胺醇溶液2.5mg雾化吸入布地奈德/福莫特罗干粉吸入剂进行治疗.观察两组患者在治疗12周后肺功能、哮喘急性发作、哮喘控制测试(ACT)评分以及不良反应之间的差异. 结果 在试验结束时雾化吸入治疗组在清晨测定呼气峰流速(PEF)改善绝对值为(29.2±14.4) ml,优于常规吸入治疗组的(15.8±13.5) ml(t=3.715,P=0.000),雾化组ACT评分改善为(4.8±2.2)分,亦高于常规组的(3.0±2.7)分(t=2.897,P=0.005).而两组在日均缓解药物使用次数及严重急性发作次数间均差异无统计学意义(￡=-1.512,P=0.136;x2 =2.238,P=0.135).吸入激素引起的局部不良反应上两组亦差异无统计学意义. 结论 与干粉吸入剂相比,采用雾化吸入的给药方式规律吸入糖皮质激素及支气管扩张剂,能更好地改善病情严重的高龄老年哮喘患者的临床症状及肺功能水平.同时该方法在为期12周的连续治疗中显示出了良好的安全性.     

孟鲁司特钠联合布地奈德治疗支气管哮喘疗效观察

目的对孟鲁司特钠联合布地奈德治疗支气管哮喘疗效进行观察。方法资料选自2012年10月~2013年10月我院收治的支气管哮喘患者64例,平均分为两组,单纯给予对照组患者布地奈德治疗,研究组则采用孟鲁司特钠联合布地奈德进行治疗,并对两组临床资料等进行回顾性分析。结果经治疗后,研究组FEV1、PEER及FVE等指标,明显优于对照组;且研究组总有效率93.75%,明显高于对照组总有效率78.13%,比较均有差异具有统计学意义(P<0.05)。结论孟鲁司特钠联合布地奈德治疗支气管哮喘的疗效较为显著,值得在临床中推广应用。     

Effectiveness of early budesonide intervention in Caucasian versus Asian patients with asthma: 3-year results of the START study

OBJECTIVE AND BACKGROUND: Few studies have assessed the effectiveness of inhaled corticosteroid therapy exclusively in Asian patients with asthma. The present analysis compared the efficacy of early intervention with inhaled budesonide in Caucasian and Asian patients over the first 3 years of the inhaled Steroid Treatment As Regular Therapy in early asthma study. METHODS: Patients aged 5-66 years with mild persistent asthma of 相似文献   

Once-daily budesonide/formoterol in a single inhaler in adults with moderate persistent asthma

Patients with moderate persistent asthma (n = 523; mean FEV1 77.4%) not fully controlled with inhaled corticosteroids (ICS; 400-1000 microg/day) were randomized to receive either once-daily budesonide/formoterol (160/4.5 microg, two inhalations); or twice-daily budesonide/formoterol (160/4.5 microg, one inhalation); or budesonide (400 microg) once-daily for 12 weeks. Once-daily dosing was administered in the evening and twice-daily dosing was administered in the morning and evening. All patients received twice-daily budesonide (200 microg) during a 2-week run-in. Compared with budesonide alone, change in mean morning and evening peak expiratory flow was greater in the once-daily budesonide/formoterol group (27 and 171 min(-1), respectively; P < 0.001) and twice-daily budesonide/formoterol group (23 and 24 l min(-1), respectively; P < 0.001). Night awakenings, symptom-free days, reliever-use-free days and asthma-control days were all improved during once-daily budesonide/formoterol therapy vs. budesonide (P < or = 0.05). Similar improvements were also seen with twice-daily budesonide/formoterol (P < or = 0.05). The risk of a mild exacerbation was reduced after once- and twice-daily budesonide/formoterol vs. budesonide (38% and 35%, respectively; P < 0.002). All treatments were well tolerated. Budesonide/formoterol, once- or twice-daily, in a single inhaler improved asthma symptoms and exacerbations compared with budesonide. In the majority of patients with moderate persistent asthma requiring ICS and long-acting beta-agonists, once-daily formoterol/budesonide provided sustained efficacy over 24 h, similar to twice-daily dosing.     

Ciclesonide is more effective than budesonide in the treatment of persistent asthma

BACKGROUND: Ciclesonide is a lung-activated inhaled corticosteroid that provides effective control of persistent asthma. The objective of this study was to compare the efficacy and safety of once-daily ciclesonide versus once-daily budesonide in patients with asthma. METHODS: A total of 399 patients with asthma were randomised to receive once-daily ciclesonide 320 microg ex-actuator (equivalent to 400 microg ex-valve) or once-daily budesonide 400 microg for 12 weeks. The primary endpoint was forced expiratory volume in 1s (FEV(1)). Additional efficacy variables included forced vital capacity (FVC), peak expiratory flow (PEF), asthma symptoms, use of rescue medication and time to onset of effect. Adverse events were monitored throughout the study. RESULTS: Both ciclesonide and budesonide significantly increased FEV(1) from baseline (416 and 321 ml, respectively; p<0.0001). The increase in FEV(1) was significantly greater in ciclesonide-treated patients (95% confidence interval: 0.016-0.174; p=0.019 versus budesonide). Similarly, ciclesonide and budesonide significantly improved FVC and PEF from baseline (p<0.0001), and significantly greater increases occurred with ciclesonide (p=0.034 and 0.019 versus budesonide, respectively). Analysis of morning PEF revealed an earlier onset of action for ciclesonide versus budesonide; a significant improvement was seen by day 2 (p=0.039 versus baseline) with ciclesonide compared with day 7 for budesonide (p=0.047 versus baseline). Adverse events occurred with a similar incidence in both treatment groups. Neither treatment caused significant changes in urinary cortisol levels. CONCLUSION: Once-daily ciclesonide was more effective than once-daily budesonide in improving FEV(1), FVC and PEF. Ciclesonide also had an earlier onset of action than budesonide in patients with persistent asthma. Both ciclesonide and budesonide had good safety and tolerability profiles.     

Efficacy and safety of high-dose budesonide/formoterol (Symbicort) compared with budesonide administered either concomitantly with formoterol or alone in patients with persistent symptomatic asthma

OBJECTIVE AND BACKGROUND: Budesonide/formoterol 160/4.5 microg, two inhalations bd, is an effective and well-tolerated maintenance therapy for patients not controlled on inhaled corticosteroids alone. The authors assessed the efficacy and safety of a higher dose of budesonide/formoterol in patients with persistent symptomatic asthma. METHODS: This was a 24-week, double-blind, double-dummy randomized study. Budesonide/formoterol 320/9 microg, two inhalations bd (1280/36 microg/day), was compared with corresponding doses of budesonide during weeks 1-12 and budesonide plus formoterol via separate inhalers during weeks 1-24. Efficacy was assessed during weeks 1-12; the primary variable was morning PEF. Safety was assessed over weeks 1-24. RESULTS: Patients (n=456; aged 12-79 years) had a mean reversibility in FEV1 of 28% and mean pre-study inhaled corticosteroid dose of 1038 microg/day. Mean morning PEF increased by 37 L/min and 36 L/min with budesonide/formoterol and budesonide plus formoterol, respectively, versus an increase of 5 L/min with budesonide (P<0.001 for both vs. budesonide). Budesonide/formoterol increased time to first mild exacerbation (P<0.005) versus budesonide. Budesonide/formoterol and budesonide plus formoterol had similar efficacy. All treatments were well tolerated and the incidence of class-related adverse events was similarly low in all groups. Changes in serum potassium and plasma cortisol were comparable across treatments. CONCLUSIONS: High-dose budesonide/formoterol (320/9 microg, two inhalations bd) is effective and well tolerated in patients with persistent symptomatic asthma. The findings also support the safety of regular high-dose formoterol (36 microg/day).     

Effects of early intervention with inhaled budesonide on lung function in newly diagnosed asthma

STUDY OBJECTIVES: Asthmatic patients lose lung function faster than normal subjects. The effectiveness of early intervention with inhaled corticosteroids on this decline in lung function is not established in recent-onset disease. DESIGN: The Inhaled Steroid Treatment as Regular Therapy in Early Asthma study was a randomized, double-blind study in 7,165 patients (5 to 66 years old), with persistent asthma for < 2 years to determine whether early intervention with low-dose inhaled budesonide prevents severe asthma-related events and the decline in lung function. Patients received budesonide (200 mug qd for children < 11 years old and 400 mug qd for others) or placebo for 3 years in addition to usual asthma medications. RESULTS: Treatment with budesonide significantly improved prebronchodilator and postbronchodilator FEV(1) percentage of predicted and reduced the mean declines from baseline for postbronchodilator FEV(1) at 1 year and 3 years: - 0.62% and - 1.79% for budesonide and - 2.11% and - 2.68% for placebo, respectively (p < 0.001). The decline was more marked for male patients, active smokers, and patients > 18 years old, and the smallest treatment effects were in adolescents. CONCLUSIONS: Long-term, once-daily treatment with low-dose budesonide improved both prebronchodilator and postbronchodilator FEV(1) in patients with recent-onset, persistent asthma, and reduced the loss of lung function over time.     

Comparative efficacy of once-daily ciclesonide and budesonide in the treatment of persistent asthma

BACKGROUND: The aim of this study was to compare the efficacy and safety of once-daily ciclesonide, a new-generation, on-site-activated, inhaled corticosteroid, with once-daily budesonide in persistent asthma. METHODS: Eligible patients requiring budesonide or equivalent 320-640 microg (ex-mouthpiece, equivalent to 400-800 microg; Turbohalertrade mark) daily entered a 2-week baseline, and then a 2- to 4-week pretreatment period (budesonide 1280 microg/day; ex-mouthpiece, equivalent to 1600 microg/day). Patients with an increase in forced expiratory volume in 1s (FEV1) of 7% or 0.15 L were randomised to ciclesonide 320 microg (ex-actuator, equivalent to 400 microg ex-valve) via a hydrofluoroalkane-metered dose inhaler (HFA-MDI) without a spacer or budesonide 320 microg once daily in the morning for 12 weeks. Change in FEV1 was the primary endpoint. RESULTS: In all, 359 patients were randomised. The FEV1 and forced vital capacity (FVC) decreased by 0.18 and 0.12L, respectively, in the ciclesonide group, and by 0.23 and 0.21L in the budesonide group. For FEV1, ciclesonide was noninferior and numerically superior to budesonide. For FVC, ciclesonide was statistically superior to budesonide (P=0.010). Asthma symptom scores were comparable; the median percentage of symptom-free days was significantly higher for ciclesonide (43.6%) versus budesonide (25.8%) (P=0.017). Rescue medication use decreased significantly only for ciclesonide patients (P=0.009). Frequency of adverse events was low in both groups. CONCLUSION: Ciclesonide 320 microg once daily by HFA-MDI without a spacer was at least as effective as budesonide 320 microg once daily in persistent asthma.     

Once-daily dosing with budesonide/formoterol compared with twice-daily budesonide/formoterol and once-daily budesonide in adults with mild to moderate asthma

Adherence to maintenance therapy is often poor in patients with asthma. Simplifying dosing regimens has the potential to improve both adherence and asthma-related morbidity. In this 12-week, randomized, double-blind, double-dummy, parallel-group study, 617 patients with mild to moderate persistent asthma (mean forced expiratory volume in 1s [FEV1] 78.5% predicted) who were not optimally controlled on inhaled corticosteroids (200-500 microg/day) were randomized to once-daily budesonide/formoterol (80/4.5 microg, 2 inhalations in the evening), twice-daily budesonide/formoterol (80/4.5 microg, 1 inhalation), or a corresponding dose of budesonide once-daily (200 microg, 1 inhalation in the evening). All patients received budesonide (100 microg twice daily) during a 2-week run-in. Changes in mean morning peak expiratory flow (PEF) were similar for od budesonide/formoterol (23.4 l/min) and twice-daily budesonide/formoterol (24.1 l/min), and both were greater than with budesonide (5.5 l/min; both P<0.001). Evening PEF, symptom-free days, reliever-free days, and asthma control days were improved with budesonide/formoterol therapy vs. budesonide (P<0.05 vs. budesonide for all variables). All treatments were well tolerated. Budesonide/formoterol administered once daily in the evening is a convenient treatment regimen that is as effective in improving asthma control as twice-daily dosing in patients with mild to moderate persistent asthma.     

Budesonide/formoterol in a single inhaler versus inhaled corticosteroids alone in the treatment of asthma

The aim of this study was to evaluate the efficacy (expressed as effect on lung function) and tolerability of Symbicort (budesonide/formoterol in a single inhaler) in children with asthma. This was a double-blind, double-dummy, randomized, parallel-group, multicenter trial. After a 2-4-week run-in period, 286 asthmatic children (177 boys, 109 girls; mean age, 11 years; mean forced expiratory volume in 1 sec (FEV(1)), 75% predicted normal), previously treated with inhaled corticosteroids (average dose 548 microg/day), were randomized to 12 weeks' treatment with either budesonide/formoterol 80/4.5 microg, two inhalations twice daily (n = 148), or an equivalent dose of budesonide 100 microg, two inhalations twice daily (n = 138). Efficacy variables included morning and evening peak expiratory flow (PEF), spirometery, asthma symptoms, and use of rescue medication (beta(2)-agonists). Serial FEV(1) assessments were carried out on a subgroup of children (budesonide/formoterol, n = 41; budesonide, n = 40) at randomization and at week 12. Relative to baseline, morning PEF (primary variable) increased to a significantly greater extent with budesonide/formoterol than with budesonide alone (7.22% predicted normal vs 3.45% predicted normal; P < 0.001). Evening PEF also increased significantly with budesonide/formoterol (6.13% predicted normal vs. 2.73% predicted normal; P < 0.001), as did mean FEV(1) and serial FEV(1) measured over 12 hr (both P < 0.05). Similar improvements in asthma symptoms and rescue medication use were observed in both groups. The two treatment groups were similar in terms of their adverse-event profile and rates of discontinuation. Budesonide/formoterol in a single inhaler provided rapid improvements in PEF and FEV(1) compared to inhaled budesonide alone. These improvements were sustained throughout the study period. Budesonide/formoterol was well-tolerated in children with moderate persistent asthma.     

Budesonide/formoterol in a single inhaler rapidly relieves methacholine-induced moderate-to-severe bronchoconstriction

Inhalers containing corticosteroids and long-acting beta2-agonists are becoming increasingly important in asthma management. A rapid effect is important to patients, particularly during exacerbations. We compared the onset of bronchodilation and patient-perceived relief from dyspnoea following single-inhaler budesonide/formoterol or salmeterol/fluticasone in a model of acute bronchoconstriction. A randomised, double-blind, double-dummy, single-dose, crossover study included 27 outpatients with asthma (mean age 35 years; mean FEV1 90% predicted normal). Immediately following methacholine-induced bronchoconstriction (fall in FEV1 > or = 30%), patients inhaled budesonide/formoterol (160/4.5 microg, 1 or 2 inhalations; Symbicort Turbuhaler), salmeterol/fluticasone (50/250 microg; Seretide Diskus) or placebo on 4 study days. Lung function and Borg score were assessed for 30 min. During methacholine-induced provocation (final mean FEV1 62.5% of baseline), mean Borg score increased 10-fold (from 0.3 to 3.0 units). Hereafter, mean FEV1 at 3 min improved significantly more after budesonide/formoterol 1 and 2 inhalations (37 and 38%, respectively) than after salmeterol/fluticasone (23%; P < 0.001) or placebo (10%; P < 0.001). Median recovery times to 85% of baseline FEV1 were shorter for budesonide/formoterol (1 or 2 inhalations: 3.3 and 2.8 min, respectively) than salmeterol/fluticasone (8.9 min; P < 0.001) and placebo (> 30 min). One min after budesonide/formoterol, dyspnoea was significantly reduced (Borg score -0.86 units, both doses) compared with salmeterol/fluticasone (-0.55 units; P < 0.05) and placebo (-0.23 units; P < 0.001). Budesonide/formoterol provides immediate bronchodilation, faster than salmeterol/fluticasone, which patients can feel during acute methacholine-induced bronchoconstriction.     

Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease.

The efficacy and safety of budesonide/formoterol in a single inhaler compared with placebo, budesonide and formoterol were evaluated in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). In a 12-month, randomised, double-blind, placebo-controlled, parallel-group study in 812 adults (mean age 64 yrs, mean forced expiratory volume in one second (FEV1) 36% predicted normal), patients received two inhalations twice daily of either budesonide/formoterol (Symbicort) 160/4.5 microg (delivered dose), budesonide 200 microg (metered dose), formoterol 4.5 microg or placebo. Severe exacerbations and FEV1 (primary variables), peak expiratory flow (PEF), COPD symptoms, health-related quality of life (HRQL), mild exacerbations, use of reliever beta2-agonist and safety variables were recorded. Budesonide/formoterol reduced the mean number of severe exacerbations per patient per year by 24% versus placebo and 23% versus formoterol. FEV1 increased by 15% versus placebo and 9% versus budesonide. Morning PEF improved significantly on day 1 versus placebo and budesonide; after 1 week, morning PEF was improved versus placebo, budesonide and formoterol. Improvements in morning and evening PEF versus comparators were maintained over 12 months. Budesonide/formoterol decreased all symptom scores and use of reliever beta2-agonists significantly versus placebo and budesonide, and improved HRQL versus placebo. All treatments were well tolerated. These results suggest a role for budesonide/formoterol in the long-term management of moderate-to-severe chronic obstructive pulmonary disease.