Phase 2
N=68
Symptom Clusters in Children With Exacerbation-prone Asthma
Asthma in Children
Bottom Line
View on ClinicalTrials.gov: NCT04002362 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Change in Asthma Control Questionnaire (ACQ) Score — 0.52 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Triamcinolone Acetonide (Drug)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Asthma Control Questionnaire (ACQ) Score |
0.52 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Asthma Impact Scale (PAIS) |
42.7; 42.9; 44.7 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04002362). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.