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Efficacy of Intramuscular Steroid Injection for Chronic Cough.

NCT06634823 EARLY_PHASE1 RECRUITING

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.

Details

Lead sponsorMedical University of South Carolina
PhaseEARLY_PHASE1
StatusRECRUITING
Enrolment40
Start dateMon Dec 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionTue Jun 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

United States