Efficacy of Intramuscular Steroid Injection for Chronic Cough.

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT06634823
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Cough (CC)
  • Coughing
  • Laryngeal Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Triamcinolone Acetonide Injectable Suspension — DRUG
    Triamcinolone injection into deltoid muscle (arm)
  • Saline injection — DRUG
    Saline injection into deltoid muscle (arm)

Study Details

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.

Key Dates

Start date
Dec 2, 2024
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Placebo injection into deltoid (arm)
  • Experimental: Steroid
    Triamcinolone injection into deltoid (arm)

Primary Outcome Measure

Leicester Cough Questionnaire [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29403
Laryngology Office
[email protected]
843-792-6755
Lauren Howser, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Charleston, SC

By research site
Medical University of South Carolina· Charleston, SC

Related Studies