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

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 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。有些哮喘恶化没有明显的原因，推测与气道炎症和高反应性的（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，当疾病体征或症状恶化时增加治疗强度，当疾病体征或症状改善时减少治疗强度。然而，进行这些调整，特别是治疗强度的下调的指导方针尚未制定。我们假设，对于最初通过每日低剂量吸入皮质类固醇治疗得到良好控制的患者，吸入皮质类固醇治疗的基于症状的调整[SBA]和/或基于生物标志物的调整[BBA]在维持哮喘控制方面将优于基于标准、基于指南的调整[GBA]，根据治疗失败的时间进行评估。与基于指南的治疗失败时间调整（主要结果）相比，我们将评估基于症状或基于生物标志物的哮喘治疗调整的益处。这项研究被提议作为一项三臂、平行组随机、双盲、双模拟试验，由 6 个阶段组成。 该研究将有助于确定这种治疗方法在治疗哮喘方面的有效性。

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.