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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• History consistent with chronic unexplained or refractory cough

• Age ≥ 18

Locations
United States
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Contact Information
Primary
Kirsten Meenan
meenan@musc.edu
843-792-6755
Backup
Lauren Howser
howser@musc.edu
843-792-6755
Time Frame
Start Date: 2024-12-02
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 40
Treatments
Placebo_comparator: Placebo
Placebo injection into deltoid (arm)
Experimental: Steroid
Triamcinolone injection into deltoid (arm)
Related Therapeutic Areas
Sponsors
Leads: Medical University of South Carolina

This content was sourced from clinicaltrials.gov