Asthma Clinical Trial
Official title:
Mechanisms Underlying Asthma Exacerbations Prevented and Persistent With Immune-Based Therapy: A Systems Approach Phase 1 (ICAC-29)
Asthma is a growing problem, especially in children. It causes frequent wheezing, shortness of breath, chest tightness, and cough. A cold that is caused by a virus (viral cold) can sometimes make asthma symptoms worse. This study will help investigators learn about the way colds are related to asthma attacks among children who need higher amounts of medications to control their asthma. Investigators want to learn why viral colds sometimes cause asthma attacks and other times do not by studying the immune system response in samples taken from the nose and blood.
This study 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 years 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 approximately 6 months
after Visit 0, whichever comes first.
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