40 Participants Needed

Steroid Injection for Chronic Cough

LH
KM
Overseen ByKirsten Meenan
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Medical University of South Carolina
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I need to stop taking my current medications for the trial?

The trial requires that you stop taking any neuromodulating medications used for chronic cough before participating.

What data supports the effectiveness of the drug Triamcinolone Acetonide Injectable Suspension for chronic cough?

Triamcinolone acetonide has shown effectiveness in treating severe asthma and allergic rhinitis, with significant improvement in symptoms and fewer side effects compared to other treatments. This suggests it may also help with chronic cough, which can be related to similar respiratory issues.12345

Is triamcinolone acetonide generally safe for humans?

Triamcinolone acetonide, used in various conditions, has shown some side effects like weight gain, menstrual changes, and increased blood pressure in a small percentage of patients. However, in many cases, it has been used safely without serious side effects, especially when precautions are taken.12567

How does the drug Triamcinolone Acetonide Injectable Suspension differ from other treatments for chronic cough?

Triamcinolone Acetonide Injectable Suspension is unique because it is administered as an injection, which can provide a longer-lasting effect compared to oral medications. This method of delivery can be beneficial for patients who have difficulty adhering to daily oral treatments, as it requires less frequent dosing.12358

What is the purpose of this trial?

The primary goal of this study is to test the hypothesis that injecting steroid intramuscularly is an effective treatment for unexplained chronic cough. This will be achieved through the design of a prospective, placebo-controlled, single-blind, randomized clinical trial in which one group of patients will undergo a steroid injection into the deltoid muscle and the second group will undergo a placebo injection into the deltoid muscle. Data to determine if a clinically significant difference exists between the outcomes of the two groups will be measured by a dichotomous yes/no response to improvement, the Leicester Cough Questionnaire, and a visual analogue scale for symptom severity. This will provide the answer to the general question of whether or not the intramuscular injections are clinically effective for patients with unexplained chronic cough. Furthermore, any adverse reactions will be thoroughly documented. If this hypothesized treatment is proven effective, this can greatly improve the care of chronic cough patients by allowing for an evidence-based treatment option and a treatment option that may improve access to care. While the superior laryngeal nerve (SLN) injection is typically performed by fellowship trained laryngologists, intramuscular injections could be more widely utilized by general otolaryngologists or providers in other fields of medicine.

Research Team

LH

Lauren Howser

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

This trial is for individuals with unexplained chronic cough, possibly due to conditions like laryngitis or chronic bronchitis. Participants should not have received similar treatments recently and must be able to attend all study visits. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I have a long-term cough that treatments haven't helped.

Exclusion Criteria

Current smokers
My lung function tests have been abnormal since my cough began.
My diabetes is not under control (A1c > 7%).
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a triamcinolone injection or a placebo injection into the deltoid muscle

4 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment using the Leicester Cough Questionnaire and Visual Analog Scale

4 weeks

Treatment Details

Interventions

  • Triamcinolone Acetonide Injectable Suspension
Trial Overview The trial tests if steroid injections into the muscle (Triamcinolone Acetonide) are more effective than placebo (saline injection) in treating chronic cough. It's a controlled study where patients don't know which treatment they get, but researchers do.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SteroidExperimental Treatment1 Intervention
Triamcinolone injection into deltoid (arm)
Group II: PlaceboPlacebo Group1 Intervention
Placebo injection into deltoid (arm)

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

🇺🇸
Approved in United States as Kenalog for:
  • Allergic reactions
  • Skin conditions
  • Respiratory conditions
  • Rheumatic disorders
  • Ophthalmic conditions
🇪🇺
Approved in European Union as Triamcinolone Acetonide Injectable Suspension for:
  • Allergic reactions
  • Skin conditions
  • Respiratory conditions
  • Rheumatic disorders
  • Ophthalmic conditions
🇨🇦
Approved in Canada as Triamcinolone for:
  • Allergic reactions
  • Skin conditions
  • Respiratory conditions
  • Rheumatic disorders
  • Ophthalmic conditions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

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.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.
Corticosteroid injections of the nasal turbinates: past experience and precautions.McCleve, D., Goldstein, J., Silver, S.[2019]
In a trial involving 40 sarcoidosis patients treated with intramuscular triamcinolone acetonide (Kenacort A), the treatment showed a higher rate of improvement in chest findings compared to oral prednisolone, indicating its efficacy.
The intramuscular treatment also resulted in fewer side effects and a significant improvement in ocular lesions, suggesting it may be a safer alternative to oral corticosteroids.
Parenteral treatment of sarcoidosis with triamcinolone.Mikami, R., Hiraga, Y., Yotsumoto, H., et al.[2013]

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]
Parenteral treatment of sarcoidosis with triamcinolone. [2013]
Intramuscular triamcinolone acetonide in chronic severe asthma. [2019]
Granulomatous Reaction to Intralesional Kenalog (Triamcinolone) Injection in Acne: A Case Report. [2020]
Suprachoroidal Space Triamcinolone Acetonide: A Review in Uveitic Macular Edema. [2022]
Subtenon Triamcinolone Acetonide Injection with Topical Anesthesia in Pediatric Non-Infectious Uveitis. [2023]
Triamcinolone in corticosteroid-resistant asthma. [2013]
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