Personalized Treatment Algorithms for Difficult-to-treat Asthma

Cincinnati Children's Hospital Medical Center

Status and phase

Completed

Phase 2

Conditions

Asthma in Children

Treatments

Drug: Fluticasone Propionate

Drug: Azithromycin

Drug: Cholecalciferol

Drug: Asthma Controller Medication

Drug: emollient cream

Drug: antihistamine

Study type

Interventional

Funder types

Other

Identifiers

NCT04179461

ARC 7

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

21 participants in 1 patient group

Personalized Treatment

Experimental group

Description:

Personalized asthma treatment plan based off of individual's asthma severity/control, personal and family medical history, history of environmental exposures, adherence, medical visits, biomarker assays, and home trigger assessment. Study participants were prescribed recommended medications for the treatment of their asthma. These medications were prescribed through their insurance based of the of personalized treatment plan recommendation. Asthma controller medications may be increased based off of the participant's asthma control and the recommendation of the personalized plan. They would receive one of the asthma controller medications listed in the intervention.