Symptom Clusters in Children With Exacerbation-prone Asthma
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.
Conditions:
🦠 Asthma in Children
🗓️ Study Start (Actual) 13 November 2019
🗓️ Primary Completion (Estimated) 31 July 2025
✅ Study Completion (Estimated) 31 July 2025
👥 Enrollment (Estimated) 173
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Atlanta, Georgia, United States
📍 Atlanta, Georgia, United States

📋 Eligibility Criteria

Description

    Inclusion 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

    Exclusion Criteria:

    • * 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
Ages Eligible for Study: 6 Years to 21 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 27 June 2019
  • First Submitted that Met QC Criteria 27 June 2019
  • First Posted 28 June 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 July 2024
  • Last Update Posted 17 July 2024
  • Last Verified July 2024