Trial Outcomes & Findings for Symptom Clusters in Children With Exacerbation-prone Asthma (NCT NCT04002362)

Last Updated: 2026-02-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

68 participants

Primary outcome timeframe

Baseline, Day 14

Results posted on

2026-02-13

Participant Flow

Participants were recruited from the Emory Children's Center and Children's Healthcare of Atlanta in Atlanta, Georgia, USA. Participant enrollment began November 13, 2019 and all follow-up assessments for the Day 14 time point were completed by January 16, 2025. Follow-up assessments for the Week 48 time point were completed by December 24, 2025..

Participant milestones

Participant milestones
Measure	Triamcinolone Acetonide Pediatric participants with exacerbation-prone asthma receiving an intramuscular injection of triamcinolone acetonide and are followed for 48 weeks. Triamcinolone Acetonide: 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.
Overall Study STARTED	68
Overall Study COMPLETED	67
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Triamcinolone Acetonide Pediatric participants with exacerbation-prone asthma receiving an intramuscular injection of triamcinolone acetonide and are followed for 48 weeks. Triamcinolone Acetonide: 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.
Overall Study Lost to Follow-up	1

Baseline Characteristics

Symptom Clusters in Children With Exacerbation-prone Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Triamcinolone Acetonide n=68 Participants Pediatric participants with exacerbation-prone asthma receiving an intramuscular injection of triamcinolone acetonide and are followed for 48 weeks. 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.
Age, Categorical <=18 years	66 Participants n=6 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=6 Participants
Age, Categorical >=65 years	0 Participants n=6 Participants
Age, Continuous	10.6 years STANDARD_DEVIATION 3.7 • n=6 Participants
Sex: Female, Male Female	26 Participants n=6 Participants
Sex: Female, Male Male	42 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	68 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants
Race (NIH/OMB) Asian	2 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	50 Participants n=6 Participants
Race (NIH/OMB) White	16 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants
Region of Enrollment United States	68 Participants n=6 Participants

PRIMARY outcome

Timeframe: Baseline, Day 14

Population: This analysis includes participants who completed both the Baseline and Day 14 study assessments.

Outcome measures

Outcome measures
Measure	Triamcinolone Acetonide n=67 Participants Pediatric participants with exacerbation-prone asthma receiving an intramuscular injection of triamcinolone acetonide and are followed for 48 weeks. 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.
Change in Asthma Control Questionnaire (ACQ) Score	0.52 score on a scale Standard Deviation 0.89

SECONDARY outcome

Timeframe: Weeks 16, 32, and 48

Quality of life is assessed with the 8-item PAIS instrument. As with all PROMIS measures, the PAIS is scored on the T-score metric, with higher scores reflecting more of the concept being measured. On the T-score metric, 50 is the mean of the reference population and 10 is the standard deviation, thus, scores of 40 and 60 are one standard deviation lower and higher than the mean of the reference population, respectively.

Outcome measures

Outcome measures
Measure	Triamcinolone Acetonide n=62 Participants Pediatric participants with exacerbation-prone asthma receiving an intramuscular injection of triamcinolone acetonide and are followed for 48 weeks. 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.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Asthma Impact Scale (PAIS) Week 16	42.7 T-score Standard Deviation 9.8
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Asthma Impact Scale (PAIS) Week 32	42.9 T-score Standard Deviation 9.8
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Asthma Impact Scale (PAIS) Week 48	44.7 T-score Standard Deviation 10.7

Adverse Events

Triamcinolone Acetonide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anne Fitzpatrick, PhD

Emory University

Phone: 404-727-9112

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place