COMPLETED

Symptom Clusters in Children With Exacerbation-prone Asthma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Pediatric participants with exacerbation-prone asthma will receive an intramuscular injection of triamcinolone acetonide and will be followed for 48 weeks. The study visit 2 weeks after the injection will assess the response to the study medication, while the remaining study visits will examine the temporal stability of the symptom clusters.

Official Title

Symptom Clusters in Children With Exacerbation-prone Asthma

Quick Facts

Study Start:2019-11-13

Study Completion:2025-12-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04002362

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.

Ages Eligible for Study:6 Years to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Age 6 to less than 21 years at the enrollment visit * Physician diagnosis of asthma * History of an asthma exacerbation in the previous 12 months, defined as either: * Treatment with systemic corticosteroids, or * Increase in rescue medication use (i.e., albuterol or inhaled corticosteroid) for 24 hours or more, or * One or more missed school days due to asthma symptoms, or * An unscheduled visit for asthma at either a physician's office, urgent care, hospital emergency room, or * Hospitalization for asthma	* Previous allergic reaction to systemic corticosteroids * Hepatic, biliary, or renal disease that can interfere with drug metabolism/excretion * Chronic medical disorders that may increase the risk of drug-related injury, including osteogenesis imperfecta (increased risk of fracture with corticosteroids), or Crohn's disease, ulcerative colitis, juvenile rheumatoid arthritis, clotting disorders, or Factor deficiency (increased risk of bleeding with corticosteroid therapy) * Pregnancy * Current smoking * Congenital disorders or deformities of the chest wall, lungs or airways * History of premature birth \<35 weeks gestation * Unwillingness to receive triamcinolone * Planning to relocate before study completion

Inclusion Criteria

Exclusion Criteria

* Age 6 to less than 21 years at the enrollment visit
* Physician diagnosis of asthma
* History of an asthma exacerbation in the previous 12 months, defined as either:
* Treatment with systemic corticosteroids, or
* Increase in rescue medication use (i.e., albuterol or inhaled corticosteroid) for 24 hours or more, or
* One or more missed school days due to asthma symptoms, or
* An unscheduled visit for asthma at either a physician's office, urgent care, hospital emergency room, or
* Hospitalization for asthma

* Previous allergic reaction to systemic corticosteroids
* Hepatic, biliary, or renal disease that can interfere with drug metabolism/excretion
* Chronic medical disorders that may increase the risk of drug-related injury, including osteogenesis imperfecta (increased risk of fracture with corticosteroids), or Crohn's disease, ulcerative colitis, juvenile rheumatoid arthritis, clotting disorders, or Factor deficiency (increased risk of bleeding with corticosteroid therapy)
* Pregnancy
* Current smoking
* Congenital disorders or deformities of the chest wall, lungs or airways
* History of premature birth \<35 weeks gestation
* Unwillingness to receive triamcinolone
* Planning to relocate before study completion

Contacts and Locations

Principal Investigator

Anne Fitzpatrick, PhD

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Children's Healthcare of Altanta

Atlanta, Georgia, 30322

United States

Emory Children's Center

Atlanta, Georgia, 30322

United States

Collaborators and Investigators

Sponsor: Emory University

Anne Fitzpatrick, PhD, PRINCIPAL_INVESTIGATOR, Emory University

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 Registration Dates

Study Start Date2019-11-13

Study Completion Date2025-12-24

Study Record Updates

Study Start Date2019-11-13

Study Completion Date2025-12-24

Terms related to this study

Keywords Provided by Researchers

Asthma
Pediatrics

Additional Relevant MeSH Terms

Asthma in Children