Symptom Clusters in Children With Exacerbation-prone Asthma

NCT04002362 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: IRB00111087R01NR018666
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Asthma in Children

Keywords

Asthma; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Change in Asthma Control Questionnaire (ACQ) Score

  Responsiveness to the study treatment is assessed with the Asthma Control Questionnaire (ACQ). This 7-item questionnaire includes questions related to daytime and nocturnal symptoms, short-acting bronchodilator use, and lung function during the clinic visit on that day. Participants report how difficult their asthma was to control on a scale from 0 (no impairment) to 6 (maximum impairment). Total raw scores range from 0 to 42, with higher scores indicating poorer asthma control. Responsiveness to treatment is determined with the mean difference in ACQ score the baseline visit and the Day 14 visit, with a reduction of 0.5 considered a minimally important difference.

  Baseline, Day 14

Secondary Outcomes (1)

• Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Asthma Impact Scale (PAIS)

  Weeks 16, 32, and 48

Study Arms (1)

Triamcinolone Acetonide

EXPERIMENTAL

Pediatric participants with exacerbation-prone asthma receiving an intramuscular injection of triamcinolone acetonide and are followed for 48 weeks.

Drug: Triamcinolone Acetonide

Interventions

Triamcinolone Acetonide DRUG

An intramuscular injection of triamcinolone acetonide (1 mg/kg, up to 40 mg maximum) is administered deep in the gluteal muscle by a trained registered nurse.

Also known as: Kenalog

Triamcinolone Acetonide

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Nursing Research (NINR): collaborator
• Emory University: lead

Study Sites (2)

Children's Healthcare of Altanta

Atlanta, Georgia, 30322, United States

Location

Emory Children's Center

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Anne Fitzpatrick, PhD
• Organization: Emory University

anne.fitzpatrick@emory.edu

404-727-9112

Study Officials

• Anne Fitzpatrick, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: June 28, 2019
• Study Start: November 13, 2019
• Primary Completion: January 16, 2025
• Study Completion: December 24, 2025
• Last Updated: February 13, 2026
• Results First Posted: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made available for sharing three months following publication, with no end date.
• Access Criteria: Data will be available for sharing with researchers who provide a methodologically sound proposal, in order to achieve the aims in the proposal. Proposals should be directed to anne.fitzpatrick@emory.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (2)