Symptom Clusters in Children With Exacerbation-prone Asthma

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: National Institute of Nursing Research (NINR)
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• Age 8 to less than 18 years at the enrollment visit

• Physician diagnosis of asthma

• History of an asthma exacerbation treated with systemic corticosteroids in the previous 12 months

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