Steroid Injection for Chronic Cough

Recruiting in Palo Alto (17 mi)

Overseen by Lauren Howser

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Medical University of South Carolina

Must not be taking: ACE inhibitors, ARBs, Neuromodulators

Disqualifiers: Smoking, Diabetes, Abnormal PFTs, others

Approved in 3 Jurisdictions

Trial Summary

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.

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 2 3 4 5}

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 5 6 7}

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 2 3 5 8}

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 am 18 years old or older.

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%).

Trial 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 (Corticosteroid)

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

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Medical University of South Carolina Charleston, SC

Who Is Running the Clinical Trial?

Medical University of South Carolina Lead Sponsor

References

1. Singapore pubmed.ncbi.nlm.nih.gov

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.

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

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.

3. Germany pubmed.ncbi.nlm.nih.gov

Parenteral treatment of sarcoidosis with triamcinolone. [2013] The parenteral use of triamcinolone acetonide (Kenacort A) is said to have the following advantages: to keep the effect for two weeks by one injection, to be able to reduce the total treatment dosage and to secure the dosage regardless of patients cooperation. From these reasons, a trial of the Kenacort A treatment was made for 40 cases with sarcoidosis by 7 times of intramuscular injection at two-week intervals: 80 mg each at the 1st and 2nd and 40 mg at the 3rd to 7th. The results were compared with the already reported double blind trial using the oral initial dosage of 30 mg of prednisolone followed by a a reduced dosage for a period of 6 months. This paper will give an interim report of the 4 month follow-up after the ceasation of treatment. The results showed: 1. the disappearance rate of chest findings, either BHL or parenchymal pulmonary lesions, was higher in this trial than the above-mentioned oral treatment, 2. the high rate of improvement was found in ocular lesion, and 3. side effects were less in this trial than the oral treatment.

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

Intramuscular triamcinolone acetonide in chronic severe asthma. [2019] Seventeen subjects with chronic severe asthma completed a 48 week prospective, double blind study with crossover of treatment at 24 weeks, in which triamcinolone acetonide 80 mg intramuscularly every four weeks was compared with oral prednisolone 10 mg daily. Spirometry, twice daily measurements of peak expiratory flow rate, and self assessment of asthma symptom scores showed significant improvement during triamcinolone treatment; less extra prednisolone was required and there was significant weight loss. Two patients withdrew, one because of dissatisfaction with prednisolone and one because of side effects while taking triamcinolone. Three were withdrawn, one with proximal muscle weakness and two because of intercurrent illness. Adrenal suppression, bruising, and hirsuitism were worse with triamcinolone, other side effects being comparable. On completion of the study 16 of the 17 patients opted to continue taking triamcinolone acetonide. This treatment is an important addition to the therapeutic options available for chronic severe asthma.

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

Granulomatous Reaction to Intralesional Kenalog (Triamcinolone) Injection in Acne: A Case Report. [2020] Intralesional Kenalog (triamcinolone) injection is a useful treatment for several skin conditions. Although dermal deposition of triamcinolone has been described in the literature, histopathologic findings of foreign body reactions to it have seldom been reported. Here, we describe a case of a granulomatous reaction to the intralesional injection of triamcinolone acetonide in the treatment of nodulocystic acne.

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

Suprachoroidal Space Triamcinolone Acetonide: A Review in Uveitic Macular Edema. [2022] Triamcinolone acetonide injectable suspension for suprachoroidal use (Xipere&#174;; SCS triamcinolone acetonide) is a corticosteroid approved in the USA for the treatment of macular edema associated with uveitis. Suprachoroidal injection of SCS triamcinolone acetonide results in preferential distribution into the posterior segment, which may reduce the risk of corticosteroid-related adverse events, such as cataracts and intraocular pressure (IOP) elevation. In a multicenter phase III trial in patients with non-infectious uveitic macular edema, SCS triamcinolone acetonide significantly and rapidly improved visual acuity and reduced signs of macular edema compared with sham treatment. SCS triamcinolone acetonide was generally well tolerated, with the most common adverse event being eye pain on the day of the procedure. The risk of corticosteroid-related IOP elevation appeared to be reduced in unrescued patients in the SCS triamcinolone acetonide group compared with patients in the sham control group who received rescue therapy. SCS triamcinolone acetonide is a novel and useful treatment option for uveitic macular edema.

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

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.

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

Triamcinolone in corticosteroid-resistant asthma. [2013] In an uncontrolled study 38 patients with chronic asthma were treated for up to 4.5 years (mean 2.9) with depot injections of triamcinolone acetonide. About half had proved difficult to control on large doses of corticosteroid tablets. Three-quarters were helped and the incidence of hospital admission amongst them was reduced. Side effects were tolerable and adrenal function was only moderately depressed. Spirometry showed continuing improvement up to three years after starting triamcinolone. Whether similar improvement could have been achieved by a different dosage regimen of corticosteroid tablets or whether it might have ocurred spontaneously was not tested. A controlled trial seems warranted.