Pneumology Unit, La Fe University Hospital, Valencia, Spain; Pneumology Service, La Fe University Hospital, Valencia, Spain; CIBERes de enfermedades Respiratorias, Valencia, Spain.
Pneumology Unit, La Fe University Hospital, Valencia, Spain.
Chest. 2012 Feb;141(2):461-468. doi: 10.1378/chest.11-0180. Epub 2011 Jul 21.
The aim of this study is to evaluate the efficacy and safety of medium-dose formoterol-budesonide combined inhaled treatment in a single inhaler compared with high-dose budesonide treatment in patients with non-cystic fibrosis (non-CF) bronchiectasis.
This is a 12-month randomized, double-blind, parallel-groups clinical trial, to run in 40 patients with non-CF bronchiectasis diagnosed by high-resolution CT scan of the chest, receiving formoterol-budesonide combined treatment (18/640 μg daily) or budesonide treatment (1,600 μg daily). Variables concerning clinical condition, health-related quality of life (HRQL), lung function, β(2)-adrenergic agonist use, potentially pathogenic microorganism (PPM) isolates, and medication side effects were analyzed by intention-to-treat analysis.
The study group receiving a formoterol-budesonide combined treatment showed a significant improvement, both clinically and statistically, of symptoms (dyspnea, number of coughs, and rescue β(2)-adrenergic agonist-free days). Furthermore, we observed an HRQL improvement, with no changes in functional parameters or in PPM isolates, together with an important reduction in overall side effects, especially for those related to inhaled steroids, compared with the high-dose budesonide treatment group.
Inhaled medium-dose formoterol-budesonide combined treatment in a single inhaler is more effective and safe compared with high-dose budesonide treatment in patients with non-CF bronchiectasis.
ClinicalTrials.gov; No.: NCT00728715; URL: www.clinicaltrials.gov.
本研究旨在评估中等剂量福莫特罗-布地奈德联合吸入治疗（每日 18/640μg）与高剂量布地奈德治疗（每日 1600μg）在非囊性纤维化（非 CF）支气管扩张症患者中的疗效和安全性。
这是一项为期 12 个月的随机、双盲、平行分组临床试验，在 40 例经胸部高分辨率 CT 扫描诊断为非 CF 支气管扩张症的患者中进行，患者接受福莫特罗-布地奈德联合治疗（每日 18/640μg）或布地奈德治疗（每日 1600μg）。采用意向治疗分析方法对临床状况、健康相关生活质量（HRQL）、肺功能、β（2）-肾上腺素能激动剂使用、潜在致病性微生物（PPM）分离株和药物不良反应等变量进行分析。
接受福莫特罗-布地奈德联合治疗的研究组在症状（呼吸困难、咳嗽次数和无救β（2）-肾上腺素能激动剂自由天数）方面均有显著改善，且具有统计学意义。此外，我们观察到 HRQL 改善，而功能参数或 PPM 分离株无变化，与高剂量布地奈德治疗组相比，总体不良反应明显减少，尤其是与吸入性类固醇相关的不良反应。
与高剂量布地奈德治疗相比，在非 CF 支气管扩张症患者中，使用单吸入器吸入中等剂量福莫特罗-布地奈德联合治疗更有效且安全。
ClinicalTrials.gov；编号：NCT00728715；网址：www.clinicaltrials.gov。
