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

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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.