NCT04179461

Personalized Treatment Algorithms for Difficult-to-treat Asthma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma in Children

Interventions

Type	Name	Description
DRUG	Cholecalciferol	Oral administration
DRUG	antihistamine	Oral administration
DRUG	Azithromycin	Oral administration
DRUG	emollient cream	Topical
DRUG	Fluticasone Propionate	Nasal spray
DRUG	Asthma Controller Medication	Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan.

Timeline

• Start date: 2018-03-16
• Primary completion: 2019-10-03
• Completion: 2019-10-03
• First posted: 2019-11-27
• Last updated: 2021-08-20
• Results posted: 2021-08-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study