Triamcinolone Acetonide for Childhood Asthma

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called triamcinolone acetonide, a corticosteroid, to determine its effectiveness in helping children and young adults with asthma that easily worsens. The researchers aim to discover how well a single injection can reduce asthma symptoms over nearly a year. Participants include children and young adults who have experienced asthma flare-ups in the past year, such as needing extra medication or missing school due to asthma symptoms. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that triamcinolone acetonide is likely to be safe for humans?

Research has shown that triamcinolone acetonide is generally safe for treating asthma symptoms. In past studies, this medication effectively eased severe asthma symptoms in most patients. For example, one study found that 88.3% of children experienced significant relief from their asthma symptoms.

The medication has been used in different forms, such as inhalers, and has a consistent safety record with only minor side effects. Most children handled the medication well. However, the safety and effectiveness of triamcinolone acetonide for children have not been fully confirmed in all forms and dosages, so ongoing research remains important.

Overall, current data suggests that triamcinolone acetonide is well-tolerated in children with asthma, but continuous monitoring and further studies are essential to confirm its safety for all pediatric use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for asthma?

Triamcinolone acetonide is unique because it offers a different approach to managing childhood asthma compared to standard inhaled corticosteroids or bronchodilators. Unlike other treatments that are typically inhaled, this medication is administered as an intramuscular injection, which might be beneficial for kids who have trouble using inhalers properly. Researchers are excited about this treatment because it targets exacerbation-prone asthma and could provide longer-lasting relief, as patients are followed for 48 weeks after just one injection. This could mean fewer asthma attacks and less need for frequent medication adjustments.

What evidence suggests that triamcinolone acetonide might be an effective treatment for childhood asthma?

Research has shown that triamcinolone acetonide, the treatment under study in this trial, helps treat severe asthma in children. One study found that 88.3% of children experienced improved asthma symptoms after using this treatment. It reduces swelling in the airways, making breathing easier. Other studies have found that even when inhaled, triamcinolone acetonide is safe and effective for children with asthma. It does not cause major side effects like adrenal suppression, a concern with some steroid treatments. Overall, the evidence supports its use in effectively managing asthma symptoms. ^{1 2 4 5 6}

Who Is on the Research Team?

Anne Fitzpatrick, PhD, NP.

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Triamcinolone Acetonide Experimental Treatment 1 Intervention

Pediatric participants with exacerbation-prone asthma receiving an intramuscular injection of triamcinolone acetonide and are 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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5346343/

Systemic Corticosteroid Responses in Children with ...

This study sought to characterize systemic corticosteroid responses in children with severe asthma after treatment with intramuscular triamcinolone

2.

aafp.org

aafp.org/pubs/afp/issues/2005/0515/p1959.html

Childhood Asthma: Treatment Update

Studies have shown that, as a single agent, inhaled corticosteroids in a medium dosage are more effective than inhaled long-acting beta2 ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0011393X00885021

Comparative dose-ranging study of triamcinolone ...

Based on these results, we concluded that triamcinolone acetonide HFA inhalation aerosol is safe and effective in children with asthma and produces effects on ...

4.

jacionline.org

jacionline.org/article/0091-6749(78)90082-9/pdf

Treatment of asthma in children with triamcinolone ...

Triamcinolone acetonide aerosol is effective in the treatment of asthmatic children at doses which do not cause substantial adrenal suppression. We wish to ...

5.

withpower.com

withpower.com/trial/phase-3-syndrome-10-2019-c190d

Triamcinolone Acetonide for Childhood Asthma

The available research shows that Triamcinolone Acetonide, specifically in the form of Kenalog, was effective in treating severe asthma symptoms in 88.3% of ...

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2008/018117s042lbl.pdf

Azmacort® (triamcinolone acetonide ... - accessdata.fda.gov

Pediatric Use: Pediatric Use: Safety and effectiveness have not been established in pediatric patients ... or to Azmacort, children with severe asthma to Azmacort.