Triamcinolone Acetonide for Childhood Asthma
Recruiting in Palo Alto (17 mi)
+1 other location
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Emory University
Disqualifiers: Pregnancy, Smoking, Hepatic disease, others
No Placebo Group
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
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.
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.12489
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
Trial 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 (Corticosteroid)
Trial OverviewThe 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:
🇺🇸 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's Healthcare of AltantaAtlanta, GA
Emory Children's CenterAtlanta, GA
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Who Is Running the Clinical Trial?
Emory UniversityLead Sponsor
National Institute of Nursing Research (NINR)Collaborator
References
The use of triamcinolone acetonide in the treatment of severe intrinsic bronchial asthma. [2013]A group of 145 patients with severe intrinsic bronchial asthma symptoms was treated with repeated intramuscular injections of triamcinolone acetonide (Kenalog) during an average period of two years. Kenalog was administered mainly to persons with persistent attacks of asthmatic dyspnea and frequent recurrent infections of the respiratory tract in which other drugs, including orally administered steroids, did not lead to any improvement in the asthmatic symptoms. The results of therapy were excellent (total disappearance of asthmatic manifestations) or good (considerable improvement of asthma symptoms) in 88.3% of treated cases, while in 11.7% of patients, Kenalog had no effect. In 13.8% of cases, side effects, especially weight gain, disturbances in menstruation, increase in blood pressure, edema and spontaneous echymoses were observed. The triamcinolone acetonide depot-preparation is, in the authors' opinion, highly effective in the management of severe intrinsic asthma cases, unsucessfully treated by other methods. The prolonged use of Kenalog can, however, like other steroids provoke, several side effects.
Corticosteroid injections of the nasal turbinates: past experience and precautions. [2019]Clinical experience with triamcinolone acetonide (Kenalog) injections into the nasal turbinates for allergic and vasomotor rhinitis is reported by two authors. Gratifying results have occurred in most of the over 60,000 patients treated, with no serious side effects. Two cases of intravascular injections of another corticosteroid reaching the retinal circulation are reported, and methods for preventing this complication are proposed.
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]Tri-Nasal Nasal Spray is an investigational solution of triamcinolone acetonide (TAA) currently being evaluated as a treatment for allergic rhinitis. The safety and efficacy of 200 and 400 micrograms once daily doses of Tri-Nasal Nasal Spray, an active control (440 micrograms once daily of Nasacort Nasal aerosol), and Tri-Nasal Nasal Spray placebo were compared over a 2-week treatment period in a double-blind (the Nasacort treatment was not blinded), parallel design trial. A total of 377 adult patients in 13 centers were enrolled during the grass pollen season. The primary efficacy variable was the weekly average of the SSI (Symptom Severity Index), the sum of daily nasal congestion, rhinorrhea, and sneezing severity scores from the patient diary. A total of 355 patients completed the study. All active treatments were significantly more effective than placebo in relieving nasal symptoms at each treatment week. The 400 micrograms Tri-Nasal Nasal Spray and Nasacort treatments had a rapid onset of action, demonstrating significant improvement in the SSI versus placebo by the second day of treatment. Results for the individual nasal symptoms and other secondary efficacy measures paralleled those of the primary efficacy variables. Tri-Nasal Nasal Spray and Nasacort were comparable in safety, and in treating the nonocular symptoms of seasonal allergic rhinitis.
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]Triamcinolone acetonide (TAA) inhalation aerosol (Azmacort Inhalation Aerosol), a well-established corticosteroid treatment for bronchial asthma, utilizes the chlorofluorocarbon (CFC) propellant P-12, which will be phased out because of environmental concerns. Two TAA aerosol formulations have been developed using a non-chlorofluorocarbon propellant, HFA-134a (Azmacort HFA Inhalation Aerosol delivering TAA 75 microg/puff or 225 microg/puff).
Triamcinolone acetonide. A review of its pharmacological properties and therapeutic efficacy in the management of allergic rhinitis. [2018]Triamcinolone acetonide is a synthetic glucocorticoid which has been formulated as both an aerosol and an aqueous metered-dose pump spray for nasal inhalation in the treatment of allergic rhinitis. Nasally administered triamcinolone acetonide is not significantly absorbed into the systemic circulation and does not suppress hypothalamic-pituitary-adrenal (HPA) axis function at therapeutic dosages. Clinical trials with either formulation have shown that once-daily triamcinolone acetonide 110 to 220 micrograms reduces symptoms of allergic rhinitis within the first day of administration. Once symptoms are under control, the dosage of aqueous triamcinolone acetonide may be reduced from 220 to 110 micrograms/day without loss of effect. Both aqueous and aerosol formulations of triamcinolone acetonide are significantly more effective in relieving symptoms and reducing nasal eosinophil influx than placebo. Once-daily intranasal triamcinolone acetonide 220 micrograms/day produced similar reductions from baseline in nasal symptoms of allergic rhinitis, when measured both subjectively (visual analogue scales) and objectively (anterior rhinomanometry), to those seen with beclomethasone 84 to 168 micrograms twice daily, fluticasone 200 micrograms once daily or flunisolide 100 micrograms twice daily for 3 to 12 weeks. Furthermore, triamcinolone acetonide aerosol 220 micrograms/day was significantly more effective at reducing the nasal symptoms of allergic rhinitis than the oral antihistamines loratadine and astemizole (both 10mg daily) and was equally as effective in reducing the associated ocular symptoms. The use of intranasal triamcinolone acetonide and oral loratadine in combination did not confer any additional advantage over triamcinolone acetonide alone. Triamcinolone acetonide [110 to either 220 micrograms/day (aqueous) or 440 micrograms/day (aerosol)] was well tolerated in clinical trials; headache and epistaxis were the only adverse events considered possibly or probably related to aerosol therapy in a 1-year study (110 to 440 micrograms/day). Therefore, in accordance with the recommendations from the International Rhinitis Management Working Group regarding the use of nasal glucocorticoids, triamcinolone acetonide may be considered a first-line therapy option in adults with moderately severe seasonal allergic rhinitis with predominantly nasal symptoms and also in children and adult patients with perennial allergic rhinitis.
Pulmonary distribution and kinetics of inhaled [11C]triamcinolone acetonide. [2016]Triamcinolone acetonide (TAA) is an anti-inflammatory steroid used for topical treatment of allergic rhinitis and asthma. Drug deposition onto target tissues is an important parameter, so methods for accurate deposition measurement are needed. Lung deposition is especially problematic to measure because of the large field of view and low relative drug penetration. Our main objective was to use PET to measure the deposition and postdeposition kinetics of TAA in the lung after administration from the Azmacort inhaler. The second objective was to evaluate changes in distribution caused by the inhalation spacer that is built into the product.
Anaphylaxis following intralesional triamcinolone acetonide (Kenacort) injection. [2020]Intralesional triamcinolone acetonide injection is indicated for multiple skin conditions such as keloid scars, alopecia areata, and hypertrophic lichen planus. Immediate hypersensitivity reaction remains uncommon. We report on a 24-year-old woman who had received multiple intralesional injections with triamcinolone acetonide (Kenacort) plus lidocaine for keloid scar treatment without any reaction for the previous 10 years. The immediate reaction occurred 15 minutes after injection, with numbness on her face and 5 minutes later with urticaria on her chest wall and upper extremities, together with hypotension (blood pressure of 90/60 mmHg). Allergology workup revealed positive skin prick test for triamcinolone acetonide (Kenacort). Skin tests for other corticosteroids (hydrocortisone, methylprednisolone, and dexamethasone), excipients (carboxymethylcellulose, benzyl alcohol, and polysorbate 80) and lidocaine were negative, including subcutaneous challenge for lidocaine and oral challenge for carboxymethylcellulose. IgE-mediated hypersensitivity reaction must be considered in cases of multiple applications of triamcinolone acetonide injection.
Subtenon Triamcinolone Acetonide Injection with Topical Anesthesia in Pediatric Non-Infectious Uveitis. [2023]Subtenon triamcinolone acetonide (Kenalog®; Bristol Myers Squibb) (STA) injections are commonly used in the treatment of adults in an outpatient setting. However, publications on detailing its outpatient use, safety, and efficacy in the pediatric population are scarce.
Placebo-controlled, double-blind study of the efficacy and safety of triamcinolone acetonide aerosol nasal inhaler in pediatric patients with seasonal allergic rhinitis. [2019]Triamcinolone acetonide (TAA) aerosol nasal inhaler has been shown to effectively relieve the symptoms of seasonal allergic rhinitis in adults and adolescents. We conducted a study to evaluate the efficacy and safety of once-daily administration of TAA aerosol nasal inhaler in pediatric patients aged 6 to 11 years with grass seasonal allergic rhinitis. This multicenter, randomized, double-blind, placebo-controlled, parallel-group study enrolled 116 children who were treated with either TAA aerosol nasal inhaler (220 micrograms/d) or placebo once daily for 2 weeks. Patients evaluated the severity of rhinitis symptoms (nasal stuffiness, discharge, sneezing, and itching) daily according to a four-point scale (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). Patients' and physicians' global evaluations of overall treatment efficacy were assessed at the end of the 2-week treatment period. Patients treated with TAA aerosol nasal inhaler had significantly greater reductions in all nasal symptom scores overall and in virtually all symptoms at the end of week 1 and week 2 compared with those in the placebo group. Both patients' and physicians' global evaluations of efficacy favored TAA aerosol nasal inhaler over placebo. This study demonstrated that once-daily administration of 220 micrograms of TAA aerosol nasal inhaler was well tolerated and effectively reduced the symptoms of seasonal allergic rhinitis in pediatric patients.