Personalized Treatment Algorithms for Difficult-to-treat Asthma

July 28, 2021 updated by: Theresa Guilbert, MD, Children's Hospital Medical Center, Cincinnati

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Cholecalciferol
Oral administration
Other Names:
  • Vitamin D
Drug: antihistamine
Oral administration
Other Names:
  • cetirizine
  • loratadine
Drug: Azithromycin
Oral administration
Other Names:
  • Zithromax
Drug: emollient cream
Topical
Drug: Fluticasone Propionate
Nasal spray
Other Names:
  • Flonase 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.
Other Names:
  • Fluticasone
  • Budesonide/Formoterol
  • Tiotropium
  • Mometasone Furoate
  • Mometasone/Formoterol
  • Fluticasone/Salmeterol
  • Beclomethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Composite Asthma Severity Index (CASI)
Time Frame: Baseline to 12 months

CASI was measured by questionnaire and is a severity score of symptom burden, exacerbations, healthcare utilization, lung function and dose of inhaled corticosteroids. The change in CASI score was calculated between V1 (Baseline), V2 (Guideline Care - before intervention), and V3 (12 Months).

[The CASI score has a minimum value = 0, maximum value = 20, a higher score indicates greater asthma severity]
Baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma Control Test (ACT)
Time Frame: Baseline to 12 months

ACT was measured by questionnaire, assessing frequency of reported asthma symptoms, rescue medication use, the effect of asthma on daily functioning, and overall asthma control. The change in ACT score was calculated between V1 (Baseline), V2 (Guideline Care - before intervention), and V3 (12 Months).

[The ACT score has a minimum value = 5, maximum value = 25, a score 19 indicates well-controlled asthma]
Baseline to 12 months
Pulmonary Function Measured by Spirometry: Forced Expiratory Volume in 1 Second (FEV1) / Forced Vital Capacity (FVC)
Time Frame: Baseline to 12 months

FEV1 is air volume exhaled in 1 second during spirometry. Forced vital capacity is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. The change in FEV1/FVC was calculated between V1 (Baseline), V2 (Guideline Care - before intervention), and V3 (12 Months). This will be used as a measurement in asthma severity.

[A lower FEV1/FVC ratio indicates more severe asthma]
Baseline to 12 months
Adherence of Asthma Controller Medication
Time Frame: Baseline to 12 months
Adherence was measured using the Propeller Health Inhaler monitor and web-based software management platform that tracks adherence of asthma medications. The change in adherence was calculated between V1 (baseline) to V3 (12 Months).
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Theresa Guilbert, MD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2018

Primary Completion (Actual)

October 3, 2019

Study Completion (Actual)

October 3, 2019

Study Registration Dates

First Submitted

November 14, 2019

First Submitted That Met QC Criteria

November 25, 2019

First Posted (Actual)

November 27, 2019

Study Record Updates

Last Update Posted (Actual)

August 20, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARC 7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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