BEST ADJUSTMENT STRATEGY FOR ASTHMA IN THE LONG TERM (BASALT)

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 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。列出的机构是 研究中心，而研究中心不一定是研究者所在的机构。 哮喘是一种常见的呼吸道疾病，其特征是气道阻塞、高反应性和炎症。一些哮喘恶化没有明显的原因，推测与气道炎症和高反应性基础的（未知）病理生理机制的变化有关。因此，哮喘治疗通常需要定期调整治疗强度，当疾病的体征或症状恶化时增加治疗强度，当疾病的体征或症状改善时减少治疗强度。然而，进行这些调整的准则，特别是治疗强度的下调，还没有很好地建立起来。我们假设，在每日低剂量吸入性糖皮质激素治疗后最初控制良好的患者中，根据至治疗失败的时间评估，吸入性糖皮质激素治疗的基于生物标志物的调整[SBA]和/或基于生物标志物的调整[BBA]在维持哮喘控制方面上级基于标准指南的调整[GBA]。我们将评估基于生物标志物或基于生物标志物的哮喘治疗调整与基于指南的治疗失败时间调整（主要结局）相比的获益。本研究拟定为三组、平行组、随机、双盲、双模拟试验，包括6个阶段。 这项研究将有助于确定这种治疗在管理哮喘方面的有效性。

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. Asthma is a common respiratory disease characterized by obstruction, hyperresponsiveness, and inflammation of the airways. Some worsening of asthma have no apparent cause, and are presumed to be related to variations in the (unknown) pathophysiologic mechanisms underlying airway inflammation and hyperresponsiveness. Accordingly, it is common for asthma therapy to require periodic adjustments in the intensity of therapy, increasing it when signs or symptoms of the disease worsen and decreasing it when they improve. However, guidelines for making these adjustments, especially downward adjustments in the intensity of treatment, have not been well established. We hypothesize that in patients initially well-controlled on daily low-dose inhaled corticosteroid therapy, symptom-based adjustment [SBA] and/or biomarker-based adjustment [BBA] of inhaled corticosteroid therapy will be superior to standard, guideline-based adjustment [GBA], in maintaining asthma control, as assessed by the time to treatment failure. We will evaluate the benefits of symptom-based, or biomarker-based therapy adjustment for asthma, compared to guideline-based adjustments on time to treatment failure (primary outcome). This study is proposed as a three-arm, parallel group randomized, doubleblind, dual-dummy trial, consisting of 6 phases. The study will help determine the effectiveness of this treatment in managing asthma.