TREATING CHILDREN TO PREVENT EXACERBATIONS OF ASTHMA (TREXA)
TREATING CHILDREN TO PREVENT EXACERBATIONS OF ASTHMA (TREXA)
批准号:
8166624
负责人:
HENGAMEH RAISSY
金额:
$3.82万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2009
资助国家:
美国
项目状态:
已结题
起止时间:
2009-12-01 至 2010-06-30
关键词:
5 year oldAdrenal Cortex HormonesAlbuterolAsthmaBeclomethasoneBreathingBudesonideChildComputer Retrieval of Information on Scientific Projects DatabaseFundingGrantGuidelinesInstitutionPatientsPharmaceutical PreparationsPhase III Clinical TrialsResearchResearch PersonnelResourcesSourceSymptomsUnited States Food and Drug AdministrationUnited States National Institutes of Healthbasefluticasonepreventstandard of care
中文摘要
这个子项目是许多研究子项目中利用
资源由NIH/NCRR资助的中心拨款提供。子项目和
调查员(PI)可能从NIH的另一个来源获得了主要资金,
并因此可以在其他清晰的条目中表示。列出的机构是
该中心不一定是调查人员的机构。
这项研究正在研究如何安全地停止每日的哮喘药物,称为吸入性皮质类固醇,并在哮喘恶化时进行管理。
哮喘指南建议在哮喘控制了1-3个月后停止使用吸入性皮质类固醇(如氟替卡松、倍氯米松、布地奈德和莫米松)。尽管日常哮喘症状可能得到控制,但一些人在停止每日吸入皮质类固醇药物后,仍可能出现哮喘恶化。护理的标准是使用沙丁胺醇来控制哮喘恶化。然而,在这项研究中,我们想看看如果在需要的基础上,在沙丁胺醇的基础上使用名为倍氯米松HFA的吸入皮质类固醇,是否可以更好地控制哮喘恶化。这是一项III期试验,这意味着将倍氯米松HFA与沙丁胺醇联合使用来控制哮喘恶化是一项研究。食品和药物管理局[FDA]还没有批准使用这种组合来管理哮喘恶化。然而,倍氯米松HFA已被批准用于5岁及以上患者的哮喘维持。有研究表明,类似的联合用药能更好地控制哮喘恶化。
英文摘要
This subproject is one of many research subprojects utilizing the
resources provided by a Center grant funded by NIH/NCRR. The subproject and
investigator (PI) may have received primary funding from another NIH source,
and thus could be represented in other CRISP entries. The institution listed is
for the Center, which is not necessarily the institution for the investigator.
This research is studying how to safely stop daily asthma medication, called inhaled corticosteroids and manage asthma exacerbations when they happen.
Asthma guidelines recommend stopping the use of inhaled corticosteroids (such as fluticasone, beclomethasone, budesonide, and mometasone) when asthma has been controlled for 1-3 months. Although daily asthma symptoms may be controlled, some people may still have asthma exacerbations after stopping their daily inhaled corticosteroid medication. The standard of care is to use albuterol to control asthma exacerbations. However, in this study we would like to see if asthma exacerbations can be better managed if an inhaled cortocosteroid, called beclomethasone HFA is used, in addition to albuterol on an 'as needed' basis. This is a phase III trial meaning that the use of beclomethasone HFA in combination with albuterol for the management of asthma exacerbation is INVESTIGATIONAL. The Food and Drug Administration [FDA] has not approved the use of this combination for the management of asthma exacerbations. However, beclomethasone HFA has been approved to be used in the maintenace of asthma in patients 5 years of age and older. There are studies that have shown that similar combinations have managed asthma exacerbation better.
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会议论文
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