Triamcinolone Acetonide for Childhood Asthma

Recruiting at 1 trial location

Overseen By Anne Fitzpatrick, PhD

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Emory University

Disqualifiers: Pregnancy, Smoking, Hepatic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 17

Duration: 2 weeks

173 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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. ^{1 2 3 6 9}

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

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.

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.

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

Group I: Children receiving triamcinolone acetonide Experimental Treatment 1 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:

Approved in United States as Triamcinolone Acetonide for:

• Knee osteoarthritis
• Skin allergies
• Respiratory allergies

Approved in European Union as Triamcinolone Acetonide for:

• Knee osteoarthritis
• Skin allergies
• Respiratory allergies

Approved in Canada as Triamcinolone Acetonide for:

• Knee osteoarthritis
• Skin allergies
• Respiratory allergies

Approved in Japan as Triamcinolone Acetonide for:

• Knee osteoarthritis
• Skin allergies
• Respiratory allergies

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of triamcinolone acetonide in the treatment of severe intrinsic bronchial asthma. Romański, 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Tri-Nasal Nasal Spray, containing triamcinolone acetonide, was found to be significantly more effective than placebo in relieving nasal symptoms of allergic rhinitis, with results showing improvement as early as the second day of treatment in a study involving 377 adult patients over a 2-week period.

Both the 400 microgram dose of Tri-Nasal Nasal Spray and the active control, Nasacort, demonstrated comparable safety profiles and efficacy in treating nonocular symptoms of seasonal allergic rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Rosenthal, R., Berger, W., Bronsky, E., et al.[2019]

Triamcinolone acetonide, when administered nasally at doses of 110 to 220 micrograms, effectively reduces symptoms of allergic rhinitis within the first day and does not affect the body's HPA axis, making it a safe option for treatment.

In clinical trials, triamcinolone acetonide was found to be more effective than oral antihistamines and comparable to other nasal glucocorticoids, supporting its use as a first-line therapy for both seasonal and perennial allergic rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triamcinolone acetonide. A review of its pharmacological properties and therapeutic efficacy in the management of allergic rhinitis. Jeal, W., Faulds, D.[2018]

In a study involving 30 children with non-infectious uveitis, subtenon triamcinolone acetonide (STA) injections showed significant efficacy, with 85.4% of eyes experiencing inflammation improvement and 77.8% resolution of macular edema at the 3-month follow-up.

The procedure was safe, with no immediate complications reported, and only a 12.5% incidence of ocular hypertension at 6 months, indicating that STA injections are a well-tolerated treatment option for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subtenon Triamcinolone Acetonide Injection with Topical Anesthesia in Pediatric Non-Infectious Uveitis. Jung, JL., Harasawa, M., Patnaik, JL., et al.[2023]

Using PET scans, the study found that 10% to 15% of the inhaled triamcinolone acetonide (TAA) dose was deposited in the target airway regions, with a significant amount remaining in these areas over time, indicating effective local delivery.

The built-in inhalation spacer in the Azmacort inhaler significantly improved drug deposition in the lungs by 2 to 5 times while reducing oral cavity deposition by about 40%, enhancing the overall efficacy of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary distribution and kinetics of inhaled [11C]triamcinolone acetonide. Berridge, MS., Lee, Z., Heald, DL.[2016]

A 24-year-old woman experienced an immediate hypersensitivity reaction to intralesional triamcinolone acetonide after 10 years of successful treatment for keloid scars, highlighting that such reactions, while uncommon, can occur even after multiple prior injections without issues.

Allergy testing confirmed a positive reaction specifically to triamcinolone acetonide, indicating that IgE-mediated hypersensitivity should be considered in patients receiving repeated injections of this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anaphylaxis following intralesional triamcinolone acetonide (Kenacort) injection. Laisuan, W., Wongsa, C., Dchapaphapeaktak, N., et al.[2020]

In a study involving 116 children aged 6 to 11 years, the once-daily use of a 220 microgram TAA aerosol nasal inhaler significantly reduced symptoms of seasonal allergic rhinitis compared to a placebo over a 2-week period.

Both patients and physicians reported greater overall treatment efficacy with TAA, indicating it is a well-tolerated and effective option for managing allergic rhinitis in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo-controlled, double-blind study of the efficacy and safety of triamcinolone acetonide aerosol nasal inhaler in pediatric patients with seasonal allergic rhinitis. Banov, CH., Silvers, WS., Green, AW., et al.[2019]

References

1. Singapore pubmed.ncbi.nlm.nih.gov

The use of triamcinolone acetonide in the treatment of severe intrinsic bronchial asthma. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Corticosteroid injections of the nasal turbinates: past experience and precautions. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

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]

4. United States pubmed.ncbi.nlm.nih.gov

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]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Triamcinolone acetonide. A review of its pharmacological properties and therapeutic efficacy in the management of allergic rhinitis. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Subtenon Triamcinolone Acetonide Injection with Topical Anesthesia in Pediatric Non-Infectious Uveitis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Pulmonary distribution and kinetics of inhaled [11C]triamcinolone acetonide. [2016]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Anaphylaxis following intralesional triamcinolone acetonide (Kenacort) injection. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Placebo-controlled, double-blind study of the efficacy and safety of triamcinolone acetonide aerosol nasal inhaler in pediatric patients with seasonal allergic rhinitis. [2019]