Symptom Clusters in Children With Exacerbation-prone Asthma
Symptom Clusters in Children With Exacerbation-prone Asthma
Pediatric participants with exacerbation-prone asthma will receive an intramuscular injection
 of triamcinolone acetonide and will be followed for 48 weeks. The study visit 2 weeks after
 the injection will assess the response to the study medication, while the remaining study
 visits will examine the temporal stability of the symptom clusters.
Asthma symptom control is suboptimal in the majority of children in the United States,
 despite widespread availability of asthma controller medications and standardized treatment
 guidelines. While deaths from asthma have declined, 53.7% of children with asthma continue to
 experience an exacerbation each year and the associated public health burden is substantial.

 While the factors responsible for poor asthma symptom control are complex and include limited
 access to care, poor adherence to preventative asthma medications, and exposures to
 environmental allergens and irritants such as tobacco smoke, it is also recognized that
 children with exacerbation-prone asthma are a heterogeneous group with differing clinical
 outcomes and longitudinal disease trajectories. Symptoms (defined as subjective sensations)
 can also be quite varied within and among affected children. Whereas some children have
 persistent, troublesome respiratory symptoms, others have respiratory symptoms only with
 upper respiratory infections. Mental health symptoms and social health symptoms have been
 inadequately characterized in this population, but some children with asthma also report
 depression and anxiety and impaired family functioning and relationships that may further
 worsen asthma outcomes. However, prior studies are limited by a narrow focus on individual
 symptoms in isolation. To date, there has been no attempt to identify symptom clusters
 (defined as two or more concurrent symptoms independent of other clusters) in children with
 exacerbation-prone asthma.

 Poor understanding of symptom clusters is a major shortcoming in asthma symptom science. In
 other chronic disorders such as cancer, compared with a single symptom, symptom clusters of
 pain, fatigue, sleep disturbance and mood disturbance significantly worsen patient-reported
 outcomes of functional status and quality of life. There is also emerging evidence that
 interventions for one symptom within a cluster (i.e., cognitive-behavioral therapy for pain)
 reduce the severity of other symptoms within that cluster (i.e., fatigue and sleep
 disturbance). Because children with exacerbation-prone asthma rarely report a single symptom,
 greater knowledge of the assessment (and ultimately management) of symptom clusters in these
 children has the potential to significantly improve individualized treatment and clinical
 outcomes.

 The researchers here propose a 48-week cohort study (N=173) to test the overarching
 hypothesis that symptom clusters and their associated inflammatory and metabolic pathways
 predict corticosteroid treatment responsiveness (primary objective outcome) and quality of
 life (patient-reported secondary outcome) in children 8-17 years with exacerbation-prone
 asthma.
Inclusion Criteria:

 -  Age 8 to less than 18 years at the enrollment visit

 -  Physician diagnosis of asthma

 -  History of an asthma exacerbation treated with systemic corticosteroids in the
 previous 12 months

 Exclusion Criteria:

 -  Previous allergic reaction to systemic corticosteroids

 -  Hepatic, biliary, or renal disease that can interfere with drug metabolism/excretion

 -  Chronic medical disorders that may increase the risk of drug-related injury, including
 osteogenesis imperfecta (increased risk of fracture with corticosteroids), or Crohn's
 disease, ulcerative colitis, juvenile rheumatoid arthritis, clotting disorders, or
 Factor deficiency (increased risk of bleeding with corticosteroid therapy)

 -  Pregnancy

 -  Current smoking

 -  Congenital disorders or deformities of the chest wall, lungs or airways

 -  History of premature birth <35 weeks gestation

 -  Unwillingness to receive triamcinolone

 -  Planning to relocate before study completion