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

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。 哮喘是一种常见的呼吸道疾病，以阻塞、高反应性和呼吸道炎症为特征。哮喘的一些恶化没有明显的原因，推测与呼吸道炎症和高反应性的(未知的)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，在疾病迹象或症状恶化时增加治疗强度，在症状改善时减少治疗强度。然而，进行这些调整的指导方针，特别是向下调整治疗强度，还没有很好地建立起来。我们假设，在最初每日小剂量吸入糖皮质激素治疗得到良好控制的患者中，根据治疗失败的时间评估，吸入糖皮质激素治疗的基于症状的调整[SBA]和/或基于生物标记物的调整[BBA]在维持哮喘控制方面将优于标准的基于指南的调整[GBA]。我们将评估基于症状或基于生物标记物的哮喘治疗调整与基于指南的治疗失败时间(主要结果)调整的益处。本研究为三臂、平行、随机、双盲、双模拟试验，共6期。这项研究将有助于确定这种治疗方法在控制哮喘方面的有效性。

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.