Personalized Treatment Algorithms for Difficult-to-treat Asthma
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Cholecalciferol; antihistamine; Azithromycin; emollient cream; Fluticasone Propionate; Asthma Controller Medication
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral administration; Oral administration; Oral administration; Topical; Nasal spray; Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan.
Other intervention name(s): Vitamin D; cetirizine; loratadine; Zithromax; Flonase Nasal Spray; Mometasone/Formoterol; Fluticasone/Salmeterol; Mometasone Furoate; Fluticasone; Beclomethasone; Budesonide/Formoterol; Tiotropium
Intervention MeSH terms: Vitamin D; Cholecalciferol; Fluticasone; Xhance; Mometasone Furoate; Cetirizine; Loratadine; Azithromycin; Budesonide; Beclomethasone; Emollients; Formoterol Fumarate; Tiotropium Bromide; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination; Histamine Antagonists; Histamine H1 Antagonists
Intervention model: Single Group Assignment
Intervention model description: The study has 3 study phases: baseline, intervention, and observation. Each participant will independently transition through these study phases.
Baseline period: Each participant will be given a treatment recommendation according to their asthma severity/control using the National Asthma Education and Prevention Program (NAEPP asthma guidelines).
Intervention period: Each participant will be given a personalized treatment plan based on their asthma severity/control during the baseline period, biologic, and environmental factors.
Observation period: All participants will be observed for at least 6 months. Investigators will track the participant's personal outcomes (comparing to baseline) for reutilization, symptom-free days, and quality of life.
Masking: None (Open Label)
Primary purpose: Treatment