TREATING CHILDREN TO PREVENT EXACERBATIONS OF ASTHMA (TREXA)

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 吸入性皮质类固醇（ICS）已被确定为治疗轻度持续性哮喘的最佳药物，对于每日使用ICS治疗哮喘得到良好控制的儿童，一个关键的未解决问题是这种治疗必须维持多久，以及何时可以安全地放弃和/或停止每日治疗。 据我们所知，没有任何研究系统地探讨这一问题，或确定这一决定所依据的标准。 NAEPP指南建议，在这组患者中，在症状得到可接受的控制1-3个月后，可以考虑减少ICS治疗;然而，由于缺乏证据，指南没有提供指导临床医生在这一过程中的参数。 另一个重要的考虑因素是当儿童停止常规药物治疗时，在其他轻度疾病的儿童中间歇性发生的急性加重的治疗。 治疗儿童以预防哮喘加重将检验以下假设：轻度持续性哮喘儿童，在低剂量ICS治疗下控制良好，因此有资格脱离ICS，在44周治疗期间，对首次哮喘加重时间的影响没有差异： 1. 相同剂量的ICS每日2次，并使用ICS +沙丁胺醇作为缓解剂; 2. 相同剂量的ICS每日两次，并使用安慰剂ICS +沙丁胺醇作为缓解剂; 3. 安慰剂ICS每日两次和使用ICS +沙丁胺醇作为缓解剂; 4. 安慰剂ICS每日两次和使用安慰剂ICS +沙丁胺醇作为缓解剂

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. With inhaled corticosteroid (ICS) established as the best medication for mild persistent asthma, a crucial unresolved issue in children whose asthma is under good control with daily ICS is for how long this treatment has to be maintained and when is it safe to wean and/or discontinued daily therapy. To our knowledge, no studies have systematically addressed this issue, or defined the criteria on which to base this decision. The NAEPP guidelines suggest that, in this group of patients, reducing ICS therapy can be considered after a 1-3 month period of acceptable control of symptoms; however, given the paucity of evidence, the Guidelines offer no parameters that would guide the clinician in this process. Another important consideration is treatment of exacerbations that occur intermittently in children with otherwise mild disease when a child has stopped regular medications. TReating children to prevent EXacerbations of Asthma will test the hypothesis that children with mild persistent asthma, under good control on low dose ICS and thus eligible for weaning from ICS, do not differ in their effects on time to first asthma exacerbation during 44 weeks of therapy with: 1. the same dose of ICS twice daily and use of ICS + albuterol as reliever; 2. the same dose of ICS twice daily and use of placebo ICS + albuterol as reliever; 3. placebo ICS twice daily and use of ICS + albuterol as reliever; 4. placebo ICS twice daily and use of placebo ICS + albuterol as reliever