Mechanisms Underlying Asthma Exacerbations Prevented and Persistent with Immune-Based Therapy: A Systems Approach Phase 1
Study ID: STU 062015-051
MuPPiTS-1 is a prospective, longitudinal, nested case control study designed to identify changes in gene transcription predictive of and associated with asthma exacerbations in children ages 6 to 17 with difficult-to control, exacerbation-prone asthma. Participants will be followed prospectively for the onset of a cold and a subsequent asthma exacerbation. an internet based asthma and cold symptom diary will be accessed by participants using a hand-held device. When the participant reports development of a cold, a clinic visit will be scheduled as soon as possible (within 48 hours of cold symptom onset) to collect blood and nasal samples. a second clinic visit will occur 4-6 days from the onset of cold symptoms to obtain samples after the initial cold, but prior to the use of systemic corticosteroids. Participants will be followed for up to two colds or for a maximum of 6 months.
1. Are male or female aged 6-17 years, inclusive, at Screening and Enrollment Visit (Visit 0). 2. Have a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the ICAC MOP. 3. Have a diagnosis of asthma made by a clinician >1 year prior to recruitment. 4. Have had at least 2 asthma exacerbations in the prior year, defined as a requirement for systemic corticosteroids and/or hospitalization. 5. Have the following requirement for asthma controller medication at the Screening and Enrollment Visit (Visit 0) according to the MEDS program[4, 28]: i. For participants aged 6 to 11 years, treatment with at least fluticasone 250 mcg 1 puff twice daily or its equivalent. ii. For participants aged 12 years and older, treatment with at least Advair 250/50 mcg 1 puff twice daily or its equivalent. 6. Have peripheral blood eosinophils >=150 per mm3. Results can be obtained from participation in a previous ICAC study if obtained within 6 months of the Screening and Enrollment Visit (Visit 0). 7. Are currently a non-smoker. 8. Parent/legal guardian is willing to sign the written informed consent. 9. Are willing to sign the assent form as per central IRB guidelines. 10. Have some form of insurance that covers costs of usual care asthma control and rescue medications at the Screening and Enrollment Visit (Visit 0).