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Completed

NCT Number: NCT04179461

Personalized Treatment Algorithms for Difficult-to-treat Asthma

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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Key information

Conditions

Asthma in Children

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Drug

Oral administration

Other names: Vitamin D

Antihistamine

Drug

Oral administration

Other names: cetirizine, loratadine

Azithromycin

Drug

Oral administration

Other names: Zithromax

emollient cream

Drug

Topical

Fluticasone propionate

Drug

Nasal spray

Other names: Flonase Nasal Spray

Asthma Controller Medication

Drug

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

Other names: Mometasone/Formoterol, Fluticasone/Salmeterol, Mometasone Furoate, Fluticasone, Beclomethasone, Budesonide/Formoterol, Tiotropium

Primary outcomes

  1. 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]

Secondary outcomes

  1. 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]

  2. 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]

  3. 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).

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 27, 2019
Registry last updated
Aug 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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