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Corticosteroid

Triamcinolone Acetonide for Childhood Asthma

Phase 2
Recruiting
Led By Anne Fitzpatrick, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- One or more missed school days due to asthma symptoms
History of an asthma exacerbation in the previous 12 months, defined as either:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 16, 32, and 48
Awards & highlights

Study Summary

This trial will give children with asthma that get flare-ups often a shot of medication, and then monitor them for 48 weeks to see how well it works and how long it lasts.

Who is the study for?
Children and young adults aged 6-20 with severe asthma, who've had an exacerbation in the past year. They must not have chest deformities, allergies to corticosteroids, liver/kidney issues affecting drug processing, or certain chronic disorders. Non-smokers only and not pregnant.Check my eligibility
What is being tested?
The trial tests if a shot of Triamcinolone Acetonide can manage severe asthma in kids prone to flare-ups. It's given once with follow-up for 48 weeks to see how symptoms change over time and how stable these changes are after treatment.See study design
What are the potential side effects?
Triamcinolone may cause side effects like increased risk of infections, potential impact on growth in children, mood swings, weight gain, high blood sugar levels, bone weakening (osteoporosis), and possible skin thinning at injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have missed school because of my asthma.
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I had a severe asthma attack in the last year.
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I have had an emergency visit for asthma.
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I am currently taking corticosteroids.
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I have been diagnosed with asthma by a doctor.
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I've used more emergency asthma medication for a day or longer.
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I am between 6 and 20 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 16, 32, and 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 16, 32, and 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Asthma Control Questionnaire (ACQ) Score
Secondary outcome measures
Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Asthma Impact Scale (PAIS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Children receiving triamcinolone acetonideExperimental Treatment1 Intervention
Pediatric participants with exacerbation-prone asthma will receive an intramuscular injection of triamcinolone acetonide and will be followed for 48 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Triamcinolone Acetonide
2018
Completed Phase 4
~3730

Find a Location

Who is running the clinical trial?

National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,376,388 Total Patients Enrolled
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,523 Total Patients Enrolled
Anne Fitzpatrick, PhDPrincipal InvestigatorEmory University

Media Library

Triamcinolone Acetonide (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04002362 — Phase 2
Childhood Asthma Research Study Groups: Children receiving triamcinolone acetonide
Childhood Asthma Clinical Trial 2023: Triamcinolone Acetonide Highlights & Side Effects. Trial Name: NCT04002362 — Phase 2
Triamcinolone Acetonide (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04002362 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any enrollment opportunities at present for this therapeutic investigation?

"Affirmative. According to clinicaltrials.gov, this research project is currently recruiting participants and was first published on November 13th 2019. The last update occurred on December 17th 2021, with the aim of enrolling 173 patients at 2 distinct medical facilities."

Answered by AI

What is the scope of participants involved in this experiment?

"Affirmative. The clinicaltrials.gov website reveals that this medical experiment, which was first published on November 13th 2019, is still looking for participants. A total of 173 patients have to be recruited from 2 different locations."

Answered by AI

Does the protocol for this study encompass individuals under 85 years of age?

"Candidates for this trial are expected to be between 6 and 21 years of age. There are 494 studies available for minors while the elderly have access to 1,216 distinct clinical trials."

Answered by AI

Are there any other scientific investigations that have utilized Triamcinolone Acetonide?

"Currently, 41 medical trials are being conducted to assess the effectiveness of Triamcinolone Acetonide. Out of those studies, 8 are in their final stage. Although most of these investigations occur in Columbia, Missouri, there are 75 sites across the United States that participate in this research."

Answered by AI

May I be considered as a potential participant in this research project?

"Participants for this trial should be afflicted with asthma and between the ages of 6 to 21. A total number of 173 persons is needed to complete the trial."

Answered by AI

Has the FDA sanctioned the utilization of Triamcinolone Acetonide?

"Our team at Power assigned a safety rating of 2 to Triamcinolone Acetonide since this drug is still in its Phase 2 trials, meaning that prior evidence exists for the drugs safety but not yet it's efficacy."

Answered by AI

What therapeutic applications is Triamcinolone Acetonide commonly employed for?

"Triamcinolone Acetonide is often prescribed to manage symptoms of ulcerative colitis, but has also proven effective in treating various hand, brain and skin conditions."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Children's Healthcare of Altanta
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Symptom Clusters in Children With Exacerbation-prone Asthma
Anne M Fitzpatrick 2019. "Symptom Clusters in Children With Exacerbation-prone Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04002362.
~6 spots leftby Jun 2024
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