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Personalized Treatment Algorithms for Difficult-to-treat Asthma

NCT04179461 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-08-20

Study results available
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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.

Conditions

  • Asthma in Children

Interventions

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.

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Theresa Guilbert, MD · Children's Hospital Medical Center, Cincinnati

  • Gurjit K Khurana Hershey, MD, PhD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-16
Primary Completion
2019-10-03
Completion
2019-10-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04179461 on ClinicalTrials.gov