Comparison of once daily fluticasone propionate aqueous nasal spray with once daily budesonide reservoir powder device in patients with perennial rhinitis

BACKGROUND: Previous studies comparing the corticosteroids fluticasone propionate (FP) and budesonide (BUD) in both perennial and seasonal rhinitis have shown no consistent difference between treatments. However, the therapeutic outcomes may have been influenced by study design. OBJECTIVE: To compare the effect of FP aqueous nasal spray (ANS; 200 microg/day) with BUD reservoir powder device (RPD; 200 microg/day) on rhinitis symptoms, productivity loss and device preference in patients with perennial rhinitis. METHODS: After a 2-week run-in period, 440 patients were randomized to receive either FPANS, BUD RPD or matched placebo (ANS or RPD) for 8 weeks, followed by an open-label 4-week follow-up treatment with FPANS. Patients completed diary card visual analogue scores for nasal symptoms, and questionnaires on satisfaction with the treatment and preferred choice of device. RESULTS: During weeks 1-4, the visual analogue total nasal symptom scores (VATNS) in the FPANS group were significantly lower than scores in the BUD RPD group (mean difference = -17.8; 95% CI = -34.4, -1.3; P = 0.036). FPANS also significantly reduced the VATNS compared with the ANS placebo at all time-points assessed (P < or = 0.005). BUD RPD did not significantly differ from the RPD placebo at weeks 5-8 (P = 0.167), or the ANS placebo at any time-point (P < or = 0.151). Over the 8-week treatment period FPANS was significantly more effective than BUD RPD at reducing sneezing (mean difference = -4.4; 95% CI = -8.6, -0.3; P = 0.036) and nasal itching (mean difference = -5.3; 95% CI = -9.9, -0.8; P = 0.022), and was significantly superior to the ANS placebo for all symptoms assessed at weeks 1-4 and 1-8 (P < 0.016). At the same time-points BUD RPD was no better at alleviating nasal itching than the RPD placebo (P < or = 0.306), and compared with the ANS placebo, significantly reduced only one symptom; nasal blockage (P < or = 0.016). After 8 weeks of treatment, patients preferred the ANS device to the RPD (P < 0.001), and at 12 weeks a significantly greater number of patients were satisfied with FPANS treatment compared with BUD RPD (P = 0.0019) or the respective placebos (P = 0.0001). CONCLUSION: FPANS and BUD RPD are effective therapies with a good safety profile for the treatment of perennial rhinitis but, in this direct placebo-controlled comparison, FPANS was more efficacious than BUD RPD, and the patients preferred the ANS device to the RPD.     

Comparison of Salmeterol with Beclomethasone in Adult Patients with Mild Persistent Asthma Who Are Already on Low-Dose Inhaled Steroids

Current guidelines on asthma management recommend the early use of inhaled corticosteroids. Recent studies of patients with moderate to severe asthma show that the addition of salmeterol is superior to a further increase of the steroids. In this study with adult, mild persistent asthma patients, we compared the effects of adding salmeterol 50 μg b.i.d. versus beclomethasone dipropionate (BDP) 200 μg b.i.d. (both via Diskhaler dry powder inhaler) to the low-dose inhaled steroids. A double-blind, randomized, parallel-group study was conducted with a run-in period of 2 weeks and a treatment period of 12 weeks. Patients (n = 233) were randomized with a peak expiratory flow (PEF) reversibility of 22 10% (mean ± SD) in the run-in period. The morning PEF was 84 ± 17% predicted and the age was 42 ± 14 years (45% males). The average prestudy inhaled steroid dose was 361 μg daily. Within a week of salmeterol treatment the daily PEF recordings reached maximal levels. At the end of the treatment period the evening PEF remained significantly better in the salmeterol group than in the BDP group (p = 0.036). The PEFs, measured at the general practitioners (GPs) office, were at least 95% of the predicted values and the post-salbutamol values at the end of both treatments. However, the salmeterol group had already obtained this level after 2 weeks and differed significantly from the beclomethasone group (p = 0.003 for percent predicted and p = 0.0007 for post-salbutamol PEF values). The symptom scores and the use of rescue medication showed a similar profile. Quality of life improved with both treatments, but without significant statistical differences between the groups. The frequency of adverse events, typical for beta 2-agonists, was low and showed no differences between the groups. These results showed that the addition of salmeterol is at least as effective as adding beclomethasone in normalizing peak flows and improving asthma control in mild persistent asthma patients. Furthermore, salmeterol has a much faster onset of action.     

Effects of nebulized corticosteroids therapy on hypothalamic–pituitary–adrenal axis in young children with recurrent or persistent wheeze

Inhaled corticosteroids (ICS) are preferred drugs for the long-term treatment of all severities of asthma in children. However, data about the safety of ICS in infants is lacking. So, it is essential to do further clinical studies to examine the safety and efficacy of ICS in this population. In this study, the effects of nebulized budesonide and nebulized fluticasone propionate suspensions on hypothalamic–pituitary–adrenal axis is examined in infants with recurrent or persistent wheeze. Thirty-one children aged 6–24 months admitted to our hospital between January and December 2005 with symptoms of recurrent or persistent wheeze were included in the study. The patients were randomly allocated to receive 0.25 mg BUD or 0.25 mg fluticasone propionate twice daily for 6 wk and half dose for another 6 wk with a jet nebulizer at home. Blood samples for basal cortisol concentration, adrenocarticotropic hormone, glucose, HbA1c and electrolytes were obtained at the beginning and at the end of the study. Adrenal function assessment was based on changes in cosyntropin-stimulated plasma cortisol levels. The study was completed with 31 patients, 16 of whom received BUD and 15 FP. All patients except one had plasma cortisol concentrations above 500 nmol/l (18 μg/dl) or had an incremental rise in cortisol of >200 nmol/l after stimulation. Although nebulized steroids seem to be safe in infancy, we recommend that adrenal functions should be tested periodically during long-term treatment with nebulized steroids.     

氟替卡松联合沙美特罗对小儿哮喘血清白介素的表达及气道重塑的调控作用

目的探讨氟替卡松联合沙美特罗治疗小儿支气管哮喘对患儿外周血白细胞介素4、8、12、13（IL-4、8、12、13）的表达，肺功能和气道重塑的调控作用。方法选取哮喘患儿40例，给予氟替卡松联合沙关特罗吸入，每次1mg／kg，疗程3个月。同时选取健康志愿者40例外周血作为对照组，分别对哮喘组用药前、后及对照组留取血标本，各组在抽取静脉血的同时均进行肺功能测定，采用双抗体夹心酶联免疫吸附法（ELISA）检测血清中IL-4、8、12、13含量。支气管镜活检检查评价气道重塑情况，并对药物不良反应等方面进行评价。结果哮喘组治疗前血清中IL-4、8、12、13含量与对照组比较差异有统计学意义。治疗后血清IL-4、8、12、13含量与治疗前比较差异有统计学意义，与对照组、相比无统计学意义。哮喘组在用氟替卡松联合沙美特罗用药后肺功能明显改善，气道重塑作用明显。结论氟替卡松联合沙美特罗能使哮喘患儿体内白介素表达异常得到部分纠正，并改善肺功能，促进气道重塑，从而对哮喘患儿的气道过敏反应有治疗和保护作用，能改善肺通气功能，降低气道高反应性，改善生存质量。     

Long-term studies on long-acting sympathomimetics

Long-term treatment studies with formoterol and salmeterol show that these inhaled long-actingβ ₂-agonists compared to availableβ ₂-agonists produce better bronchodilation, decrease the need for additional doses, decrease asthma symptoms, and are strongly preferred by the patients. Development of tolerance has not been found. One case history indicates that these effective bronchodilators might mask deterioration of asthma.     

Efficacy and safety of salmeterol/fluticasone propionate delivered via a hydrofluoroalkane metered dose inhaler in Chinese patients with moderate asthma poorly controlled with inhaled corticosteroids

A randomised, open-label, multicentre study compared the efficacy and tolerability of salmeterol 25 microg/fluticasone propionate 125 microg (two puffs, twice daily) delivered via a hydrofluoroalkane metered-dose inhaler (HFA-MDI) and salmeterol 50microg/fluticasone propionate 250 microg (one puff, twice daily) delivered via a Diskus inhaler in Chinese patients with moderate asthma uncontrolled with inhaled corticosteroids (ICSs). Morning peak expiratory flow (PEF) was the primary efficacy endpoint. Secondary endpoints included evening PEF, forced expiratory volume in 1 s, day and night symptom scores, rescue medication and patient self-evaluation of efficacy. Safety was assessed according to adverse events recorded. Both treatments were equipotent and significantly improved morning PEF (HFA-MDI 40 l/min; Diskus 42 l/min; p < 0.05) and all secondary endpoints (p < 0.05) from baseline, over 1-4 weeks. Similarly, both treatments were well tolerated. Salmeterol/fluticasone propionate delivered via an HFA-MDI or Diskus inhaler provides a choice of efficacious delivery systems in Chinese patients whose asthma is poorly controlled on ICSs alone.     

沙美特罗/丙酸氟替卡松联合异丙托溴铵吸入治疗重度COPD的临床研究

目的：研究沙美特罗/丙酸氟替卡松联合异丙托溴铵吸入治疗重度慢性阻塞性肺疾病（COPD）稳定期患者的临床疗效。方法：随机抽取80例COPD患者分为观察组和对照组,观察组给予沙美特罗/丙酸氟替卡松合并异丙托溴铵吸入治疗,对照组给予沙美特罗/丙酸氟替卡松治疗。分别对两组患者治疗前后的情况进行比较。结果：两组治疗后SGRQ积分均较治疗前有明显下降,但观察组下降更明显。两组治疗后的肺功能、血气等指标均有不同程度的改善,但观察组肺功能指标优于对照组。结论：联合用药治疗COPD稳定期患者具有较好的疗效,能够明显地改善COPD患者的血气和肺功能,良好地控制COPD的发展。     

沙美特罗替卡松粉吸入治疗COPD稳定期患者疗效观察

目的探讨联合吸入沙美特罗替卡松粉(50/500μg)治疗稳定期中重度慢性阻塞性肺疾病(COPD)患者的临床疗效。方法 60例中重度COPD患者随机分为试验组和对照组各30例,试验组吸入沙美特罗替卡松粉吸入剂(50/500μg),每次1吸,每日2次;对照组口服茶碱缓释剂,每12小时口服1次,每次0.2g,治疗3个月,痰液黏稠时加用盐酸氨溴索口服液10mL,每日3次口服。根据圣.乔治呼吸问卷的方法对临床症状问卷及体征检查评分,并评估肺功能变化。结果试验组与对照组比较,临床症状积分,肺功能指标的改善差异有统计学意义(P<0.05)。结论吸入沙美特罗替卡松粉吸入剂(50/500μg)能改善稳定期中重度COPD患者的临床症状和肺功能。     

沙美特罗-氟替卡松联合沙丁胺醇雾化吸入治疗急性加重期慢性阻塞性肺疾病的临床观察

目的 观察沙美特罗-氟替卡松复合吸入剂联合沙丁胺醇雾化吸入治疗急性加重期慢性阻塞性肺疾病的临床疗效.方法 60例慢性阻塞性肺疾病急性加重期患者随机分为观察组和对照组各30例,对照组采用常规治疗的基础上加用沙丁胺醇氧气驱动雾化吸入治疗,观察组在对照组治疗的基础上加用沙美特罗-氟替卡松复合吸入剂雾化吸入治疗,比较两组临床疗效.结果 观察组显效18例、好转10例、无效2例、总有效率93.3％;对照组显效9例、好转11例、无效10例、总有效率66.7％.两组总有效率差异有统计学意义(x2=4.60,P＜0.05).治疗后观察组一秒用力肺活量(FEV1)、功能肺活量(FVC)较治疗前、对照组治疗后均明显改善(t=2.629、2.649、2.064、2.051,均P＜0.05).结论 沙美特罗-氟替卡松干粉复合吸入剂联合沙丁胺醇氧气驱动雾化吸入治疗慢性阻塞性肺疾病急性加重期疗效优于单用沙丁胺醇.