Steroid Injection for Chronic Cough

Overseen By Kirsten Meenan

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Medical University of South Carolina

Must not be taking: ACE inhibitors, ARBs, Neuromodulators

Disqualifiers: Smoking, Diabetes, Abnormal PFTs, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

40 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{1 3 4 6 7}

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. ^{1 3 4 6 8}

Who Is on the Research Team?

Lauren Howser

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

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%).

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Steroid Experimental Treatment 1 Intervention

Triamcinolone injection into deltoid (arm)

Group II: Placebo Placebo Group 1 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

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parenteral treatment of sarcoidosis with triamcinolone. Mikami, R., Hiraga, Y., Yotsumoto, H., et al.[2013]

In a 48-week study involving 17 patients with chronic severe asthma, triamcinolone acetonide administered every four weeks showed significant improvements in lung function and asthma symptoms compared to daily oral prednisolone, with less need for additional prednisolone and notable weight loss.

Despite some side effects like adrenal suppression and bruising being more pronounced with triamcinolone, 16 out of 17 patients preferred to continue this treatment, highlighting its potential as a valuable option for managing chronic severe asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intramuscular triamcinolone acetonide in chronic severe asthma. McLeod, DT., Capewell, SJ., Law, J., et al.[2019]

Intralesional Kenalog (triamcinolone) is an effective treatment for skin conditions like nodulocystic acne, demonstrating its therapeutic potential.

However, this case highlights a rare but significant side effect: a granulomatous reaction, indicating that while the treatment is beneficial, it can also lead to adverse histopathological responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Granulomatous Reaction to Intralesional Kenalog (Triamcinolone) Injection in Acne: A Case Report. Song, Y., Guo, Y.[2020]

Triamcinolone acetonide injectable suspension (Xipere®) is effective in rapidly improving visual acuity and reducing macular edema in patients with non-infectious uveitic macular edema, as demonstrated in a multicenter phase III trial.

The suprachoroidal injection method may lower the risk of common corticosteroid-related side effects, such as increased intraocular pressure and cataracts, making it a safer treatment option compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suprachoroidal Space Triamcinolone Acetonide: A Review in Uveitic Macular Edema. Fung, S., Syed, YY.[2022]

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]

In a study of 38 patients with chronic asthma treated with depot injections of triamcinolone acetonide for an average of 2.9 years, about 75% experienced improvement in their condition, leading to a reduction in hospital admissions.

The treatment was associated with tolerable side effects and only moderate suppression of adrenal function, with spirometry results showing continued improvement for up to three years, suggesting potential long-term benefits of this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Triamcinolone in corticosteroid-resistant asthma. Peake, MD., Cayton, RM., Howard, P.[2013]

Citations

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. Germany pubmed.ncbi.nlm.nih.gov

Parenteral treatment of sarcoidosis with triamcinolone. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Intramuscular triamcinolone acetonide in chronic severe asthma. [2019]

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

Granulomatous Reaction to Intralesional Kenalog (Triamcinolone) Injection in Acne: A Case Report. [2020]

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

Suprachoroidal Space Triamcinolone Acetonide: A Review in Uveitic Macular Edema. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

Triamcinolone in corticosteroid-resistant asthma. [2013]