Efficacy of Intramuscular Steroid Injection for Chronic Cough.

NCT06634823 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: Pro00140403
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Throat; Chronic cough; Neurogenic cough; Unexplained cough

Outcome Measures

Primary Outcomes (1)

• Leicester Cough Questionnaire

  The primary outcome for which this study is powered is the change in mean Leicester Cough Questionnaire (LCQ) scores, both global and specific domains (physical, psychological, and social) from baseline to 1-4 weeks post-treatment. This score will be 19-133, with higher score indicating better outcomes.

  4 weeks

Secondary Outcomes (2)

• Visual Analog Scale

  4 weeks

• Dichotomous yes/no to symptom improvement

  4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo injection into deltoid (arm)

Drug: Saline injection

Steroid

EXPERIMENTAL

Triamcinolone injection into deltoid (arm)

Drug: Triamcinolone Acetonide Injectable Suspension

Interventions

Triamcinolone Acetonide Injectable Suspension DRUG

Triamcinolone injection into deltoid muscle (arm)

Steroid

Saline injection DRUG

Saline injection into deltoid muscle (arm)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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\*

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

RECRUITING

MeSH Terms

Conditions

Chronic Cough; Laryngeal Diseases; Cough

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Lauren Howser

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirsten Meenan

CONTACT

843-792-6755; meenan@musc.edu

Lauren Howser

CONTACT

843-792-6755; howser@musc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: December 2, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After trial completion for 1 year
• Access Criteria: Qualified researchers from academic institutions will be able to request access by contacting the PI.

Locations

US (1)