This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator. ACE is a randomized, prospective, parallel group trial. The objective of the ACE protocol is to determine whether a biomarker-supplemented approach to asthma therapy improves asthma outcomes as compared to a National Asthma Education and Prevention Program (NAEPP) guidelines-based approach without the use of this biomarker. The biomarker to be evaluated in this protocol will be exhaled nitric oxide (eNO). The primary outcome measures will be days with asthma symptoms and asthma exacerbations as measured over a run-in period of 3 weeks and a treatment strategy period of 46 weeks (49 week study period). Five hundred inner-city participants, ages 12-20 years, with persistent asthma will be studied in this trial. They will be enrolled from ten major urban areas in the United States, including fifty patients at Mount Sinai Medical Center. The study will consist of a 3-week run-in period following the Screening Visit (Visit 1) and a 46-week treatment period following the Randomization Visit (Visit 2) in which participants are placed in either the Reference Strategy Group (NAEPP guidelines alone) or the Biomarker Strategy Group (eNO measurements considered with NAEPP guidelines). Participants in both treatment strategy groups will be supported and managed with rescue algorithms of beta-agonists, and/or short courses of prednisone for asthma exacerbation in a manner consistent with NAEPP guidelines. The asthma medication regimen consists of six treatment levels, starting with low-dose Fluticasone DPI (100 mcg bid), and moving up to Advair Diskus at 100 mcg/50 mcg bid, 250 mcg/50 mcg bid, and 500 mcg/50 mcg bid with either low dose theophylline or montelukast, as needed. A double-blind design will be used so that the treatment strategy assignment is unknown to the participant, study physician, asthma counselor, and the participant's own (non-study) physicians. The study coordinator is unblinded. Hypothesis:' A treatment strategy aimed at reducing eNO (biomarker strategy) in addition to the recommendations in the existing NAEPP guidelines (reference strategy) will lead to more effective asthma control, as determined by a reduction in asthma symptoms and exacerbations.' The addition of eNO (as a biomarker for inflammation) to standard of care (NIH Guidelines) will reduce asthma symptoms and exacerbations.' Exhaled nitric oxide will be a less effective treatment adjunct for those children highly sensitized and exposed to indoor allergens.
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