Personalized Treatment Algorithms for Difficult-to-treat Asthma

Personalized Treatment Algorithms for Difficult-to-treat Asthma: Bench to Community

Asthma is a common, complex and costly chronic condition. Moreover, asthma is heterogeneous in terms of treatment response. This heterogeneity contributes to the difficulty in both studying and treating asthma. This is a pilot study to improve health outcomes in youths with difficult to treat asthma with ongoing symptoms and healthcare utilization despite medium to high doses of inhaled corticosteroids. Asthma heterogeneity in both disease pathophysiology and treatment response contributes to the difficulty in both studying and managing asthma. In order to begin to develop personalized algorithms for patients, investigators need to model novel biomarkers and other factors that contribute to individual differences in asthma outcome and test other factors that contribute to individual differences in asthma outcome and test personalized treatment strategies.

With this study investigators will conduct study visits to determine and quantify known molecular, genetic, genomic, epigenetics, immunologic, and exposure biomarkers that will help elucidate molecular disease endotype within the difficult-to-treat phenotype. This information will be used along with clinical, psychosocial, and adherence data to develop a personalized treatment plan. Following the personalized treatment plan, study clinicians will prescribe the medications through a home delivery or routine pharmacy depending on the family's preference and covered by the participant's health insurance. Investigators will track disease outcome metrics including exacerbations, symptom-free days, and asthma symptom scores to determine the effectiveness of this personalized approach.

Inclusion Criteria:

• History of provider-diagnosed asthma

• Meets one of the following definition for NAEPP guidelines uncontrolled moderate persistent asthma or severe persistent asthma in the past 12 months:

  • NAEPP step 3-4 with one of the following criteria in the past 12 months:

    • Two Asthma Control Test (ACT) scores <20
    • 1 Urgent Care or Emergency Department visit or hospitalization for asthma
    • >2 prednisone bursts

  • NAEPP step 5-6

• Current health insurance coverage at enrollment. This will be verified at V1 at the registration desk. If the family loses insurance during the study, the patient will be referred to the pulmonary social worker and financial office for assistance

• Reside at a primary home on average 5 out of 7 days a week.

• Primary home is within a 40 mile radius of Cincinnati Children's Base location or PI's discretion.

Exclusion Criteria:

• Received biologic therapy 6 months prior to enrollment
• Received systemic steroids 6 weeks prior to enrollment
• Active chronic disease apart from asthma or allergic disease
• Co-morbid lung disease
• Dependence on immunosuppressive drugs for a condition other than asthma
• Participant is pregnant
• Has a severe bleeding disorder
• Has significant developmental disability
• Share a bedroom with a currently enrolled Breath Warriors study participant