Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
ID06634823

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

Led by Medical University of South Carolina · Updated on 2025-07-14

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether injecting steroids into the muscle can effectively treat unexplained chronic cough, a condition where the cause of persistent cough is unknown. This trial is designed as a prospective, placebo-controlled, single-blind, randomized clinical study comparing steroid injections to placebo. The study aims to find out if these injections improve symptoms by measuring patient responses, cough-specific questionnaires, and symptom severity scores, while also documenting any side effects. Participants will be randomly assigned to receive either a steroid injection called Triamcinolone Acetonide or a saline injection into the deltoid muscle of the arm. The treatment is given as a one-time injection in the deltoid muscle, and the study will compare the outcomes between the two groups to see if steroid injections provide significant relief. This approach may offer a more accessible treatment option than nerve injections typically done by specialists. During the study, participants will be assessed over four weeks using the Leicester Cough Questionnaire, a visual analog scale for symptom severity, and a simple yes/no measure of symptom improvement. Researchers will carefully monitor for any adverse reactions. The total participation time includes the initial injection and follow-up evaluations over a one-month period to assess treatment effects and safety.

CONDITIONS

Brief Title

Efficacy of Intramuscular Steroid Injection for Chronic Cough.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • History consistent with chronic unexplained or refractory cough
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • 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*

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single injection with follow-up lasting up to 4 weeks

Participants receive intramuscular injections of either steroid medication or placebo in the deltoid muscle to evaluate the effect on chronic cough.

1 baseline injection visit and 1 follow-up visit

Trial Site Locations

Total: 1 location

1

Medical University of South Carolina

Charleston, South Carolina, United States, 29403

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Research Team

K

Kirsten Meenan

L

Lauren Howser

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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