RecruitingEarly Phase 1NCT06634823

Efficacy of Intramuscular Steroid Injection for Chronic Cough.

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


Sponsor

Medical University of South Carolina

Enrollment

40 participants

Start Date

Dec 2, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

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

Exclusion Criteria9

  • 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\*

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Interventions

DRUGTriamcinolone Acetonide Injectable Suspension

Triamcinolone injection into deltoid muscle (arm)

DRUGSaline injection

Saline injection into deltoid muscle (arm)


Locations(1)

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT06634823


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