173 Participants Needed

Triamcinolone Acetonide for Childhood Asthma

Recruiting at 1 trial location
AF
Overseen ByAnne Fitzpatrick, PhD
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Emory University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop your current medications. However, since the trial involves an injection of triamcinolone acetonide, it's best to discuss your current medications with the study team.

What data supports the idea that the drug Triamcinolone Acetonide for Childhood Asthma is an effective treatment?

The available research shows that Triamcinolone Acetonide, specifically in the form of Kenalog, was effective in treating severe asthma symptoms in 88.3% of patients who had not improved with other treatments. This suggests that it can be a strong option for managing asthma when other drugs don't work. However, it's important to note that some side effects were observed, such as weight gain and increased blood pressure. While the research primarily focuses on adults, it indicates potential effectiveness for severe cases, which could be relevant for childhood asthma as well.12345

What safety data is available for triamcinolone acetonide in treating childhood asthma?

Triamcinolone acetonide has been used in various forms for treating asthma and other conditions. In a study with 145 patients with severe asthma, 13.8% experienced side effects such as weight gain, menstrual disturbances, increased blood pressure, edema, and bruising. Another report noted no serious side effects in over 60,000 patients treated for rhinitis, though rare cases of serious complications like anaphylaxis have been documented. Overall, while effective, triamcinolone acetonide can cause side effects similar to other steroids.12678

Is the drug Triamcinolone Acetonide promising for treating childhood asthma?

Yes, Triamcinolone Acetonide is promising for treating childhood asthma. It has been shown to effectively improve asthma symptoms in patients where other treatments failed. It also effectively reduces symptoms of seasonal allergies in children, making it a versatile option for managing respiratory issues.12369

What is the purpose of this trial?

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.

Research Team

AF

Anne Fitzpatrick, PhD, NP.

Principal Investigator

Emory University

Eligibility Criteria

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.

Inclusion Criteria

I have missed school because of my asthma.
My first study visit is scheduled at least two weeks after my last steroid dose.
My first study visit is scheduled at least two weeks after my last steroid dose.
See 7 more

Exclusion Criteria

I do not have conditions like osteogenesis imperfecta or Crohn's that increase injury risk with certain drugs.
I was born with a chest, lung, or airway disorder.
I do not want to receive triamcinolone treatment.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an intramuscular injection of triamcinolone acetonide and are assessed for treatment response

2 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of symptom clusters and quality of life

48 weeks
Visits at weeks 16, 32, and 48 (in-person or virtual)

Treatment Details

Interventions

  • Triamcinolone Acetonide
Trial Overview 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.
Participant Groups
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.

Triamcinolone Acetonide is already approved in United States, European Union, Canada, Japan for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Triamcinolone Acetonide for:
  • Knee osteoarthritis
  • Skin allergies
  • Respiratory allergies
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Triamcinolone Acetonide for:
  • Knee osteoarthritis
  • Skin allergies
  • Respiratory allergies
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Triamcinolone Acetonide for:
  • Knee osteoarthritis
  • Skin allergies
  • Respiratory allergies
๐Ÿ‡ฏ๐Ÿ‡ต
Approved in Japan as Triamcinolone Acetonide for:
  • Knee osteoarthritis
  • Skin allergies
  • Respiratory allergies

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials
623
Recruited
10,400,000+

Findings from Research

In a study of 145 patients with severe bronchial asthma, repeated intramuscular injections of triamcinolone acetonide (Kenalog) resulted in excellent or good outcomes in 88.3% of cases, indicating its high efficacy for patients who did not respond to other treatments.
While Kenalog was effective, 13.8% of patients experienced side effects such as weight gain and increased blood pressure, highlighting the need for careful monitoring during prolonged steroid use.
The use of triamcinolone acetonide in the treatment of severe intrinsic bronchial asthma.Romaล„ski, B., Pawlik, K., Wilewska-Klubo, T.[2013]
Triamcinolone acetonide (Kenalog) injections into the nasal turbinates have been successfully used in over 60,000 patients for treating allergic and vasomotor rhinitis, showing positive results without serious side effects.
The authors highlight the importance of preventing complications, such as intravascular injections that can affect the retinal circulation, by proposing specific methods to avoid this risk.
Corticosteroid injections of the nasal turbinates: past experience and precautions.McCleve, D., Goldstein, J., Silver, S.[2019]
The new TAA-HFA 225 formulation demonstrated similar safety and efficacy to the existing TAA-CFC aerosol in treating moderate-to-severe persistent asthma, based on a study involving 538 patients over 12 weeks.
Both TAA-HFA and TAA-CFC significantly improved pulmonary function and reduced asthma symptoms compared to placebo, with benefits observed within just one week of treatment, making TAA-HFA a viable and environmentally friendly alternative.
Placebo-controlled, comparative study of the efficacy and safety of triamcinolone acetonide inhalation aerosol with the non-CFC propellant HFA-134a in patients with asthma. Azmacort HFA Clinical Study Group.Jacobson, K., Chervinsky, P., Noonan, M., et al.[2019]

References

The use of triamcinolone acetonide in the treatment of severe intrinsic bronchial asthma. [2013]
Corticosteroid injections of the nasal turbinates: past experience and precautions. [2019]
Placebo-controlled, comparative study of the efficacy and safety of triamcinolone acetonide inhalation aerosol with the non-CFC propellant HFA-134a in patients with asthma. Azmacort HFA Clinical Study Group. [2019]
Tri-Nasal triamcinolone acetonide nasal spray 200 and 400 micrograms qd versus placebo and Nasacort triamcinolone acetonide nasal aerosol 440 micrograms qd in patients suffering from seasonal allergic rhinitis during the grass season. [2019]
Triamcinolone acetonide. A review of its pharmacological properties and therapeutic efficacy in the management of allergic rhinitis. [2018]
Subtenon Triamcinolone Acetonide Injection with Topical Anesthesia in Pediatric Non-Infectious Uveitis. [2023]
Pulmonary distribution and kinetics of inhaled [11C]triamcinolone acetonide. [2016]
Anaphylaxis following intralesional triamcinolone acetonide (Kenacort) injection. [2020]
Placebo-controlled, double-blind study of the efficacy and safety of triamcinolone acetonide aerosol nasal inhaler in pediatric patients with seasonal allergic rhinitis. [2019]
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