Personalized Treatment Algorithms for Difficult-to-treat Asthma

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-16

Study Completion Date

2019-10-03

Brief Summary

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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.

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Detailed Description

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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

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Asthma in Children

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Personalized Treatment

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.

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DRUG

Oral administration

antihistamine

Intervention Type DRUG

Oral administration

Azithromycin

Intervention Type DRUG

Oral administration

emollient cream

Intervention Type DRUG

Topical

Fluticasone Propionate

Intervention Type DRUG

Nasal spray

Asthma Controller Medication

Intervention Type DRUG

Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan.

Interventions

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Cholecalciferol

Oral administration

Intervention Type DRUG

antihistamine

Oral administration

Intervention Type DRUG

Azithromycin

Oral administration

Intervention Type DRUG

emollient cream

Topical

Intervention Type DRUG

Fluticasone Propionate

Nasal spray

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Vitamin D cetirizine loratadine Zithromax Flonase Nasal Spray Mometasone/Formoterol Fluticasone/Salmeterol Mometasone Furoate Fluticasone Beclomethasone Budesonide/Formoterol Tiotropium

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No