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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:

Must not have

Congenital disorders or deformities of the chest wall, lungs or airways

Unwillingness to receive triamcinolone

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 16, 32, and 48

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was born with a chest, lung, or airway disorder.

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I do not want to receive triamcinolone treatment.

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I have liver, gallbladder, or kidney conditions that could affect how drugs are processed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 16, 32, and 48

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Asthma Control Questionnaire (ACQ) Score

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 10Eligibility criteria met