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RECRUITING
NCT06634823
EARLY_PHASE1

Efficacy of Intramuscular Steroid Injection for Chronic Cough.

Sponsor: Medical University of South Carolina

View on ClinicalTrials.gov

Summary

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.

Official title: Prospective Placebo-Controlled Trial of Intramuscular Steroid Administration for the Treatment of Unexplained Chronic Cough

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-12-02

Completion Date

2026-06-30

Last Updated

2025-07-14

Healthy Volunteers

No

Interventions

DRUG

Triamcinolone Acetonide Injectable Suspension

Triamcinolone injection into deltoid muscle (arm)

DRUG

Saline injection

Saline injection into deltoid muscle (arm)

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States