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. This is a randomized, prospective, parallel group trial to evaluate if a biomarker-supplemented approach to asthma therapy improves asthma outcomes as compared to a guidelines-based approach without the use of a specific biomarker. The study will compare asthma control as measured by symptom days and exacerbations in two groups of patients: one group managed using a treatment algorithm based on symptoms, spirometry, and the current national guidelines; and the other group managed using symptoms, spirometry, guidelines and exhaled nitric oxide (eNO) measurements. The subject and the study team (except for the study coordinator) will be blinded. The hypothesis is that use of an eNO enhanced guideline-based approach to asthma therapy will improve asthma outcomes as compared to a guidelines-based approach without use of eNO. This study will involve 500 inner city participants 12-20 years of age with persistent asthma enrolled at 10 clinical centers in the U.S. (50 subjects are expected at this site). Spirometry and eNO will be measured at each visit on all participants. Exhaled breath condensates will be collected at five visits. Blood samples will be collected at Visit 2 for total and specific immunoglobulin E total eosinophil count and optional genetic studies. A second blood sample for total eosinophil count will be collected at Visit 7. All participants will undergo skin prick testing to determine sensitivity to both indoor and outdoor aeroallergens. All enrolled participants will receive clinic-based specialty asthma care, adherence assessment and adherence education. 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 either in the Reference Strategy Group or the Biomarker Strategy Group. Participants in both treatment 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 the National Asthma Education and Prevention Program (NAEPP) guidelines. Subjects will come to the GCRC for 6 short outpatient visits (each <30 minutes) for blood draws, urine collection, and pregnancy tests (Visits 1, 2, 4, 6, 7, and 8).
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