Personalized Treatment Algorithms for Difficult-to-treat Asthma
Condition: Asthma in Children
MeSH terms: Asthma
Intervention: Cholecalciferol; antihistamine; Azithromycin; emollient cream; Fluticasone Propionate; Asthma Controller Medication
Intervention description: 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.
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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
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)
Enrollment: 21.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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