Recruiting
Early Phase 1

Intramuscular Steroid

Sponsor:

Medical University of South Carolina

Code:

NCT06634823

Conditions

Chronic Cough (CC)

Laryngeal Disease

Coughing

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Triamcinolone Acetonide Injectable Suspension

Saline injection

Study Details

Brief 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.

Conditions

Chronic Cough (CC)

Laryngeal Disease

Coughing

Study ID

NCT06634823

Start date

Dec 2, 2024

Status verified date

Jul, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • History consistent with chronic unexplained or refractory cough
  • Age ≥ 18

Exclusion Criteria:

  • Current smokers
  • Uncontrolled diabetes (A1c>7%)
  • Patients on ACE inhibitors or Angiotensin II receptor blockers (ARBs)
  • Abnormal pulmonary function testing (PFTs) since start of the cough
  • Patients with uncontrolled obstructive sleep apnea
  • Abnormal chest X-ray within past 6 months
  • Uncontrolled reflux
  • Prior superior laryngeal nerve injection
  • Current neuromodulating medication use for chronic cough\*

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Placebo injection into deltoid (arm)

experimental: Steroid

Triamcinolone injection into deltoid (arm)

Interventions

Triamcinolone Acetonide Injectable Suspension

Triamcinolone injection into deltoid muscle (arm)

Saline injection

Saline injection into deltoid muscle (arm)

Primary outcome measure

  • Leicester Cough Questionnaire [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29403

Contacts

Principal Investigator:

Lauren Howser, MD

More Information

Sponsor

Medical University of South Carolina

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Throat
  • Chronic cough
  • Neurogenic cough
  • Unexplained cough

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-07-22.