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?

This trial tests whether a steroid injection (Triamcinolone Acetonide Injectable Suspension) into the arm muscle can help people with chronic cough that lacks a clear medical explanation. Participants will receive either a steroid injection or a placebo (a harmless, inactive substance) to determine which is more effective at reducing cough symptoms. The trial seeks individuals with an unexplained chronic cough who are not current smokers, do not have uncontrolled diabetes, and are not on certain medications. If effective, this treatment could simplify managing chronic cough for many. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to contribute to groundbreaking medical insights.

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 there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that triamcinolone acetonide, the steroid used in this trial, is usually well-tolerated. However, some possible side effects require attention. Serious allergic reactions, including anaphylaxis, have occurred. Other reported side effects include burning during urination, coughing, fever, and chills.

The FDA has already approved triamcinolone acetonide for other uses, indicating a known safety profile. This suggests that doctors understand how it works in the body. Participants should discuss any concerns with their healthcare providers before joining the trial. ^{1 2 3 4 5}

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

Unlike standard treatments for chronic cough, which often involve oral medications or inhalers, the investigational treatment uses a triamcinolone injection directly into the deltoid (arm). This delivery method allows the steroid to be absorbed more directly, potentially offering faster and more targeted relief. Researchers are excited about this approach because it could provide a more efficient way to manage chronic cough symptoms, especially for patients who haven't responded well to traditional therapies.

What evidence suggests that this treatment might be an effective treatment for chronic cough?

Research has shown that triamcinolone acetonide injections, which participants in this trial may receive, might help treat chronic cough. One study found that 80% of patients who received the steroid injection experienced improvement, compared to only 14% of those who received a placebo. Triamcinolone has also alleviated symptoms in severe asthma and allergies. This treatment reduces inflammation, a major cause of chronic cough. Overall, these findings suggest that triamcinolone injections could improve symptoms for those with unexplained chronic cough. ^{4 6 7 8 9}

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.

Abnormal chest X-ray within past 6 months

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 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]

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]

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]

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]

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]

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 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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06634823

Efficacy of Intramuscular Steroid Injection for Chronic Cough. In the treatment group, 80% of patients reported improvement in symptoms, while in the control group only 14% of patients reported improvement. The Leicester ...

2. withpower.com withpower.com/trial/steroid-injection-for-chronic-cough-ce58a

Steroid Injection for Chronic Cough Triamcinolone acetonide has shown effectiveness in treating severe asthma and allergic rhinitis, with significant improvement in symptoms and fewer side effects ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06634823/efficacy-of-intramuscular-steroid-injection-for-chronic-cough

Efficacy of Intramuscular Steroid Injection for Chronic Cough. In the treatment group, 80% of patients reported improvement in symptoms, while in the control group only 14% of patients reported improvement.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8058694/

Multimodal Treatments for Neurogenic Cough: A Systematic ... Medical therapy, ST, and procedural therapy were compared by analyzing LCQ, CSI, and the proportion of patients reporting cough improvement.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1755001708000109

Efficacy/risk profile of triamcinolone acetonide in severe ... The present case report shows that TA has a better benefit/risk profile than prednisone. TA can be a valuable alternative in the control of some patients with ...

6. mayoclinic.org mayoclinic.org/drugs-supplements/triamcinolone-injection-route/description/drg-20074674

Triamcinolone (injection route) - Side effects & uses This medicine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical ...

7. webmd.com webmd.com/drugs/2/drug-9275/kenalog-injection/details

Triamcinolone (Kenalog, Zilretta): Uses, Side Effects, ... What are the serious side effects of triamcinolone? · Burning or stinging when you pee; Cough or coughing up blood; Fever, sweats, chills, or ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/012041s051lbl.pdf

KENALOG®-10 INJECTION (triamcinolone acetonide ... Cases of serious anaphylaxis, including death, have been reported 3 Reference ID: 5392493 Page 4 in individuals receiving triamcinolone acetonide injection, ...

9. clintpharmaceuticals.com clintpharmaceuticals.com/files/Triamcinolone_Acetonide_SDS_v2.pdf

Safety Data Sheet Respiratory Irritation. Triamcinolone Acetonide. May cause irritation of respiratory tract. Sensitisation. Triamcinolone Acetonide. Not a dermal sensitizer ...