Budesonide/formoterol maintenance and reliever therapy: a new treatment approach for adult patients with asthma

ABSTRACT

Background: An inhaled corticosteroid (ICS) or an ICS/long-acting β₂-agonist (LABA) combination plus short-acting β₂-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.

Scope: 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 ≥ 12 years). COMPASS was a 6-month, double blind, randomized trial while COSMOS was a 1?year, dose titration study which reflected routine clinical practice. The current review focuses on the findings in both studies, among adult patients only (aged ≥ 18 years).

Findings: 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.

Conclusions: 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.     

Efficacy and safety of single therapeutic and supratherapeutic doses of indacaterol versus salmeterol and salbutamol in patients with asthma

ABSTRACT

Objective: This study compared the bronchodilator efficacy and safety of indacaterol with placebo, salbutamol and salmeterol, in patients with persistent asthma, at single therapeutic and supratherapeutic doses.

Research design and methods: This was a randomised, open-label crossover study in adult subjects with asthma (forced expiratory volume in 1 second [FEV₁] ≥?60% predicted). In part A, patients (n = 20) received single doses of indacaterol 200?µg, salbutamol 200?µg, salmeterol 50?µg and placebo. In part B, patients (n = 19) received single doses of indacaterol 1000?µg, salbutamol 1000?µg, salmeterol 250?µg and placebo.

Main outcomes measures; Results: For the primary endpoint, FEV₁ area under the effect curve during 0–24?h, indacaterol 200?µg was statistically superior to placebo and salbutamol. Indacaterol 200?µg FEV₁ was higher than placebo (5?min to 24?h), salbutamol 200?µg (4–24?h), and salmeterol 50?µg (5 and 15?min and 22 and 24?h). Few adverse events were reported; all were mild or moderate in severity. Initial changes were observed in glucose, potassium, heart rate and QTc interval, but all values remained within normal ranges. Values matched placebo levels after a shorter time for indacaterol 1000?µg than for salmeterol 250?µg.

Conclusions: In this single-dose, open-label study, indacaterol 200?µg provided effective 24‐h bronchodilation, with a longer duration than salmeterol 50?µg and a good overall safety profile. The sustained bronchodilation of indacaterol 1000?µg was not associated with sustained systemic adverse effects.     

沙美特罗替卡松治疗支气管哮喘的临床效果研究

目的探讨分析沙美特罗替卡松粉吸入剂治疗支气管哮喘的临床疗效。方法回顾性分析2009年4月～2012年5月本院收治的100例支气管哮喘患者临床资料,将100例患者随机分为两组,观察组50例患者使用沙美特罗替卡松粉吸入剂治疗,对照组50例患者采用布地奈德粉吸入治疗。比较两组患者治疗前后肺功能指标及临床症状变化。结果两组患者治疗后,临床症状、肺功能各项指标均有明显改善;治疗后观察组临床症状及肺功能改善情况明显优于对照组。结论沙美特罗替卡松粉吸入剂治疗支气管哮喘安全有效。     

沙美特罗／替卡松粉吸入剂对慢性阻塞性肺疾病患者糖代谢的影响

目的探讨沙美特罗／替卡松粉吸入剂对慢性阻塞性肺疾病患者糖代谢的影响。方法将稳定期慢性阻塞性肺疾病患者120例根据数字表法平分为两组,即治疗组与对照组各60例,对照组患者采用常规疗法．治疗组在对照组治疗基础上给予沙美特罗／替卡松吸人剂吸入治疗。结果经过观察,治疗后治疗组的FEV1、FEV1／FVC与PEF值明显高于对照组（P〈0．05）,表明其肺功能状况有了明显恢复。同时两组治疗前后的空腹血糖、餐后2h血糖比较差异均无统计学意义（P〉0．05）。结论沙美特罗／替卡松粉吸人剂的应用能在改善慢性阻塞性肺疾病患者肺功能状况的基础上,不影响糖代谢,值得临床推广应用。     

清热涤痰定喘汤联合穴位贴敷治疗支气管哮喘随机平行对照研究

[目的]观察清热涤痰定喘汤联合穴位贴敷治疗支气管哮喘疗效。[方法]使用随机平行对照方法,将78例住院及门诊患者按随机数字表法分为两组。对照组39例氨茶碱,4~6mg/kg,3次/d;沙美特罗替卡松粉吸入剂,50/250ug,1吸/次,2次/d。治疗组39例清热涤痰定喘汤(荆芥、麻黄、黄芩各12g,炙百部、炙冬花、炙金沸草、射干各6g,石膏、法夏各10g,葶苈子、苏子、神曲、山楂、橘红各15g,芦根30g);1剂/d,水煎至300mL,3次/d。痰涎壅盛、苔白腻加复方蛇胆陈皮末;腑气不通加胖大海10g,瓜壳15g;口渴加天花粉15g;舌苔黄腻加滑石15g,木通12g,郁金10g,黄连3g。穴位敷帖:在患者大椎、气海、肺俞等穴位贴敷冬病夏治消喘贴膏,白芥子、细辛各21g,甘遂、元胡各12g,皂角20g,研细末生姜汁调膏敷贴;0.5~2h/次,如皮肤异常,将贴敷时间缩短。每年夏季入伏日期,1次/10d,共贴3次。连续治疗30d为1疗程。观测临床症状、不良反应。治疗1疗程,判定疗效。[结果]治疗组痊愈25例,显效12例,无效2例,总有效率94.87%。对照组痊愈12例,显效16例,无效11例,总有效率71.79%。治疗组疗效优于对照组(P0.05)。[结论]清热涤痰定喘汤联合穴位贴敷治疗支气管哮喘效果显著,值得推广。     

固本平喘汤联合沙美特罗替卡松粉吸入治疗瘀血阻络型支气管哮喘慢性持续期随机平行对照研究

[目的]观察固本平喘汤联合沙美特罗替卡松粉吸入治疗支气管哮喘慢性持续期疗效。[方法]使用随机平行对照方法,将108例住院患者按抽签法随机分为两组。对照组54例沙美特罗替卡松粉吸入剂,1吸/次,2次/d。治疗组54例固本平喘汤(黄芪30g,补骨脂、党参各15g,甘草3g,五味子6g,麻黄、苦杏仁各10g,射干12g,桔梗、地龙各15g,全蝎、细辛各6g,紫菀、款冬花、法半夏、白芥子、桃仁打碎各12g),1剂/d,水煎200mL,早晚口服;沙美特罗替卡松粉吸入剂同对照组。连续治疗42d为1疗程。观测临床症状、不良反应。治疗1疗程,判定疗效。[结果]治疗组显效25例,有效28例,无效1例,总有效率98.75%。对照组显效20例,有效27例,无效7例,总有效率87.05%。治疗组疗效优于对照组(P0.05)。[结论]固本平喘汤联合沙美特罗替卡松粉吸入剂治疗支气管哮喘慢性持续期效果显著,值得推广。     

舒利迭治疗对慢性阻塞性肺疾病患者肺功能及血清炎症因子的影响

目的探讨应用沙美特罗/氟替卡松粉吸入剂(舒利迭)在慢性阻塞性肺疾病(COPD)稳定期治疗中对肺功能和全身炎症标记物的影响。方法选取2011年11月至2012年11月在潍坊市人民医院治疗的COPD稳定期患者60例作为研究对象。将所有患者随机分为实验组和对照组,每组各30例。对照组患者给予为期8周的常规止咳、平喘、吸氧等对症支持治疗;实验组在与对照组患者相同治疗的基础上加用沙美特罗/氟替卡松粉吸入剂(舒利迭)治疗,为期8周,单次剂量为50/500μg,每日两次。观察患者治疗前及治疗8周后血清可溶性细胞间黏附分子-1和白细胞介素IL-6、IL-8、IL-17等指标,同时观察两组患者肺功能的变化。结果实验组稳定期COPD患者血清可溶性细胞间黏附分子-1浓度在治疗前后变化差异有统计学意义(P<0.05)。实验组患者治疗后血清IL-6、IL-8、IL-17的水平较治疗前明显降低,差异有统计学意义(P<0.05)。实验组患者肺功能指标FVC、FEV1、FEV1/FVC%在治疗前后有明显统计学差异(P<0.05)。结论通过吸入沙美特罗/氟替卡松粉吸入剂可以明显改善慢性阻塞性肺疾病患者肺功能,降低患者血清中可溶性细胞间黏附分子-1及IL-6、IL-8、IL-17的水平,减轻气道炎性细胞浸润。