To investigate the prevention of OM-85 on bronchiectasis exacerbations (iPROBE) in Chinese patients: study protocol for a randomized controlled trial.
To investigate the prevention of OM-85 on bronchiectasis exacerbations (iPROBE) in Chinese patients: study protocol for a randomized controlled trial.
复制标题
调查 OM-85 对中国患者支气管扩张加重 (iPROBE) 的预防作用：随机对照试验的研究方案
DOI：
10.1186/1745-6215-15-150
复制
发表时间：
2014-04-29
期刊：
影响因子：
2.5
通讯作者：
Kong L
中科院分区：
文献类型：
--
作者：
Gao J;Gao X;Kong L
背景非囊性纤维化支气管扩张的特征是由于反复或慢性炎症和下呼吸道感染造成气道损伤，导致中等大小支气管不可逆扩张。支气管扩张气道通常定植有细菌种类。气道感染在支气管扩张恶化中起重要作用。通过免疫刺激剂非特异性预防复发性气道感染引起了越来越多的兴趣。 OM-85 由八种对呼吸道感染重要的细菌提取物组成，可以支持呼吸道对病原体的抵抗力。多项前瞻性临床试验表明，OM-85 可降低慢性阻塞性肺疾病 (COPD) 急性加重的风险。支气管扩张的加剧会导致肺功能更快下降、生活质量下降和医疗费用增加。在此背景下，我们计划开展一项临床试验，探讨 OM-85 对中国患者支气管扩张加重的预防作用（iPROBE）。方法/设计本研究是一项前瞻性、随机、双盲、安慰剂对照的多中心试验。总共 244 名支气管扩张患者，他们在过去一年中至少有过一次支气管扩张恶化的经历。受试者将随机接受两个疗程的 7 毫克 OM-85 或匹配的安慰剂。 OM-85的治疗剂量为在研究开始时连续3个月每天口服一粒胶囊，每月10天，随后3个月不用药。这个时间表将重复，直到患者就诊一年。讨论我们将研究口服免疫刺激剂（OM-85）的长期治疗是否可以在一年内减少支气管扩张的恶化。我们还将评估其他相关结果，包括基于事件的恶化率、肺功能参数以及通过圣乔治呼吸问卷、莱斯特咳嗽问卷和炎症指数判断的总分。我们希望这项研究能够提供关于 OM-85 对支气管扩张加重的预防作用的新信息，并解决这种尚未研究的疾病的知识空白。试验注册这项研究于 2013 年 10 月 19 日在 http://www.clinicaltrials.gov（标识符 NCT01968421）注册。
BackgroundNon-cystic fibrosis bronchiectasis is characterized by the irreversible dilatation of the medium-sized bronchi as a result of airway injury from recurrent or chronic inflammation and lower respiratory tract infections. Bronchiectasis airways are commonly colonized with bacterial species. Infections of the airways play important role in bronchiectasis exacerbations. The non-specific prevention of recurrent airway infections by immunostimulating agents has gained growing interest. OM-85, consisting of extracts of eight kinds of bacteria important in respiratory infections, could support the respiratory tract resistance to the pathogens. OM-85 has been shown to be a benefit by decreasing the risk of acute exacerbation of chronic obstructive pulmonary disease (COPD) in several perspective clinical trials. Exacerbation of bronchiectasis substantially contributes to a more rapid decline in lung function, reduced quality of life, and healthcare costs. In this context, we plan to conduct a clinical trial to investigate the PReventive effect of OM-85 on Bronchiectasis Exacerbation in Chinese patients (iPROBE).Methods/DesignThis study is designed as a prospective, randomized, double blind, placebo-controlled multicenter trial. A total of 244 patients with bronchiectasis, who have had at least one exacerbation of bronchiectasis in the previous year, will be included. The subjects will randomly receive two courses of 7 mg of OM-85 or a matching placebo. The treatment dose of OM-85 will be one daily capsule taken orally for 10 days each month for 3 consecutive months at the beginning of the study, followed by 3 months of no drug. This schedule will repeat until the patient has been seen for one year.DiscussionWe will investigate whether long-term treatment with an oral immunostimulant (OM-85) could decrease exacerbations of bronchiectasis over a one-year period. We will also assess other relevant outcomes, including the rate of event-based exacerbation, lung function parameters, and total scores judged by the St George’s respiratory questionnaire, Leicester cough questionnaire, and inflammatory index. We hope that this study will provide new information on the preventive effects of OM-85 on bronchiectasis exacerbations and will address a knowledge gap for this understudied disease.Trial registrationThis study is registered at http://www.clinicaltrials.gov (identifier NCT01968421 ) on 19 October 2013.
登录
查看更多内容
影响因子：
9.6
作者：
O'Donnell, AE;Barker, AF;Fick, RB
通讯作者：
Fick, RB
影响因子：
24.3
作者：
Murray, M. P.;Turnbull, K.;Hill, A. T.
通讯作者：
Hill, A. T.
影响因子：
8.3
作者：
Nick, Jerry A;Moskowitz, Samuel M;Nichols, David P
通讯作者：
Nichols, David P
影响因子：
9.6
作者：
Angel Martinez-Garcia, Miguel;Jose Soler-Cataluna, Juan;Perpina-Tordera, Miguel
通讯作者：
Perpina-Tordera, Miguel
影响因子：
9.6
作者：
O'Donnell, Anne E.
通讯作者：
O'Donnell, Anne E.