Asthma in ChildrenPhase 2NCT04002362
Symptom Clusters in Children With Exacerbation-prone Asthma
A Phase 2 study testing Triamcinolone Acetonide in people with Asthma in Children, run by Emory University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Triamcinolone Acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Nov 2019to 24 Dec 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- History of premature birth <35 weeks gestation
- Unwillingness to receive triamcinolone
- Planning to relocate before study completion
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Healthcare of Altanta
Atlanta, Georgia, 30322
Emory Children's Center
Atlanta, Georgia, 30322
About this study
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.
Read the detailed description
Asthma symptom control is suboptimal in the majority of children in the United States, despite widespread availability of asthma controller medications and standardized treatment guidelines. While deaths from asthma have declined, 53.7% of children with asthma continue to experience an exacerbation each year and the associated public health burden is substantial.
While the factors responsible for poor asthma symptom control are complex and include limited access to care, poor adherence to preventative asthma medications, and exposures to environmental allergens and irritants such as tobacco smoke, it is also recognized that children with exacerbation-prone asthma are a heterogeneous group with differing clinical outcomes and longitudinal disease trajectories. Symptoms (defined as subjective sensations) can also be quite varied within and among affected children. Whereas some children have persistent, troublesome respiratory symptoms, others have respiratory symptoms only with upper respiratory infections. Mental health symptoms and social health symptoms have been inadequately characterized in this population, but some children with asthma also report depression and anxiety and impaired family functioning and relationships that may further worsen asthma outcomes. However, prior studies are limited by a narrow focus on individual symptoms in isolation. To date, there has been no attempt to identify symptom clusters (defined as two or more concurrent symptoms independent of other clusters) in children with exacerbation-prone asthma.
Poor understanding of symptom clusters is a major shortcoming in asthma symptom science. In other chronic disorders such as cancer, compared with a single symptom, symptom clusters of pain, fatigue, sleep disturbance and mood disturbance significantly worsen patient-reported outcomes of functional status and quality of life. There is also emerging evidence that interventions for one symptom within a cluster (i.e., cognitive-behavioral therapy for pain) reduce the severity of other symptoms within that cluster (i.e., fatigue and sleep disturbance). Because children with exacerbation-prone asthma rarely report a single symptom, greater knowledge of the assessment (and ultimately management) of symptom clusters in these children has the potential to significantly improve individualized treatment and clinical outcomes.
The researchers propose a 48-week cohort study to test the overarching hypothesis that symptom clusters and their associated inflammatory and metabolic pathways predict corticosteroid treatment responsiveness (primary objective outcome) and quality of life (patient-reported secondary outcome) in children 6- 21years of age with exacerbation-prone asthma. Participants will be given the option to either: 1) complete a single study visit, with telephone/email contacts and a review of their electronic medical record for up to 48 weeks after enrollment, or 2) complete the 48-week cohort study with scheduled study visits. Participants who select option 2 with follow-up over 48 weeks will also have the option to complete visits 3, 4 and 5 by telephone.
- Conditions
- Asthma in Children
- Being tested
- Triamcinolone Acetonide
- Keywords
- Asthma, Pediatrics
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone AcetonideDrug
Also called Kenalog
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.
| Study group | Role | What they receive |
|---|---|---|
| Triamcinolone Acetonide | Experimental | Pediatric participants with exacerbation-prone asthma receiving an intramuscular injection of triamcinolone acetonide and are followed for 48 weeks. Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 14
Secondary outcomes (1)
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Asthma Impact Scale (PAIS)
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.
Measured: Weeks 16, 32, and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start13 Nov 2019
- Primary completion16 Jan 2025
- Study completion24 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Anne M Fitzpatrick, Emory University
- Investigators
- Anne Fitzpatrick, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002362
- Sponsor's protocol ID
- IRB00111087
- Other IDs
- R01NR018666
- Status last verified
- Jan 2026
- First submitted
- 27 Jun 2019
- Last updated
- 13 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial will be available for sharing, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Clusters in Children With Exacerbation-prone Asthma
- ClinicalTrials.gov ID
- NCT04002362
- Acronym / sponsor ID
- IRB00111087
- Conditions
- Asthma in Children
- Keywords
- Asthma, Pediatrics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 16 Jan 2025 (actual)
- Study completion
- 24 Dec 2025 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Posted 26 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Asthma symptom control is suboptimal in the majority of children in the United States, despite widespread availability of asthma controller medications and standardized treatment guidelines. While deaths from asthma have declined, 53.7% of children with asthma continue to experience an exacerbation each year and the associated public health burden is substantial.
While the factors responsible for poor asthma symptom control are complex and include limited access to care, poor adherence to preventative asthma medications, and exposures to environmental allergens and irritants such as tobacco smoke, it is also recognized that children with exacerbation-prone asthma are a heterogeneous group with differing clinical outcomes and longitudinal disease trajectories. Symptoms (defined as subjective sensations) can also be quite varied within and among affected children. Whereas some children have persistent, troublesome respiratory symptoms, others have respiratory symptoms only with upper respiratory infections. Mental health symptoms and social health symptoms have been inadequately characterized in this population, but some children with asthma also report depression and anxiety and impaired family functioning and relationships that may further worsen asthma outcomes. However, prior studies are limited by a narrow focus on individual symptoms in isolation. To date, there has been no attempt to identify symptom clusters (defined as two or more concurrent symptoms independent of other clusters) in children with exacerbation-prone asthma.
Poor understanding of symptom clusters is a major shortcoming in asthma symptom science. In other chronic disorders such as cancer, compared with a single symptom, symptom clusters of pain, fatigue, sleep disturbance and mood disturbance significantly worsen patient-reported outcomes of functional status and quality of life. There is also emerging evidence that interventions for one symptom within a cluster (i.e., cognitive-behavioral therapy for pain) reduce the severity of other symptoms within that cluster (i.e., fatigue and sleep disturbance). Because children with exacerbation-prone asthma rarely report a single symptom, greater knowledge of the assessment (and ultimately management) of symptom clusters in these children has the potential to significantly improve individualized treatment and clinical outcomes.
The researchers propose a 48-week cohort study to test the overarching hypothesis that symptom clusters and their associated inflammatory and metabolic pathways predict corticosteroid treatment responsiveness (primary objective outcome) and quality of life (patient-reported secondary outcome) in children 6- 21years of age with exacerbation-prone asthma. Participants will be given the option to either: 1) complete a single study visit, with telephone/email contacts and a review of their electronic medical record for up to 48 weeks after enrollment, or 2) complete the 48-week cohort study with scheduled study visits. Participants who select option 2 with follow-up over 48 weeks will also have the option to complete visits 3, 4 and 5 by telephone.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triamcinolone Acetonide | Experimental | Drug: Triamcinolone AcetonidePediatric participants with exacerbation-prone asthma receiving an intramuscular injection of triamcinolone acetonide and are followed for 48 weeks. |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinolone AcetonideAlso: KenalogAn 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. | Drug | Triamcinolone Acetonide |
Primary outcome
Change in Asthma Control Questionnaire (ACQ) Score
Time frame: Baseline, Day 14
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.
1 secondary outcome
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Asthma Impact Scale (PAIS)
Time frame: Weeks 16, 32, and 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial will be available for sharing, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Fitzpatrick, PhD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Triamcinolone Acetonide in people with Asthma in Children, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Asthma Control Questionnaire (ACQ) Score (time frame: Baseline, Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.