Examining symptom clusters in children with asthma
Symptom Clusters in Children With Exacerbation-prone Asthma
This study is testing whether an injection of a medication can help children with asthma who often have flare-ups feel better and keep their symptoms more stable over time.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 173 (estimated) |
| Ages | 6 Years to 21 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT04002362 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of an intramuscular injection of triamcinolone acetonide in pediatric patients with exacerbation-prone asthma. Participants aged 6 to 21 years will be monitored for 48 weeks to assess their response to the medication and the stability of their symptom clusters over time. The study aims to address the complex factors contributing to poor asthma control by identifying patterns of symptoms that may affect treatment outcomes. By focusing on both respiratory and mental health symptoms, the research seeks to provide a more comprehensive understanding of asthma in children.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 21 years with a physician diagnosis of asthma and a history of exacerbations in the past year.
Not a fit: Patients with a history of allergic reactions to systemic corticosteroids or those with chronic medical conditions that may complicate treatment are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved asthma management strategies for children, enhancing their quality of life and reducing exacerbation rates.
How similar studies have performed: Previous studies have shown varying degrees of success in addressing asthma management, but this approach focusing on symptom clusters is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Atlanta, Georgia and 1 other locations
- Children's Healthcare of Altanta — Atlanta, Georgia, United States (Recruiting)
- Emory Children's Center — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Anne Fitzpatrick, PhD — Emory University
- Study coordinator: Anne Fitzpatrick, PhD
- Email: anne.fitzpatrick@emory.edu
- Phone: 404-727-9112
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.