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NCT06634823 · ClinicalTrials.gov registry record · Early Phase 1
Efficacy of Intramuscular Steroid Injection for Chronic Cough.
A Early Phase 1 study of Laryngeal Disease and Chronic Cough (CC), sponsored by Medical University of South Carolina.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06634823: Recruiting Early Phase 1 study of Laryngeal Disease and Chronic Cough (CC), sponsored by Medical University of South Carolina.
NCT06634823 is a Early Phase 1 study of Laryngeal Disease and Chronic Cough (CC) that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 40 participants, below the 700-participant average among 3 other Laryngeal Disease trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06634823, a Early Phase 1 study of Laryngeal Disease and Chronic Cough (CC), is actively recruiting participants, sponsored by Medical University of South Carolina.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Triamcinolone Acetonide Injectable Suspension
- DRUG Saline injection
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-12-02 |
| Est. Completion | 2026-06-30 |
| Phase | Early Phase 1 |
What NCT06634823 shows while recruiting
NCT06634823 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 700-participant average among 3 other Laryngeal Disease trials with a reported enrollment target (94% lower).
The record links to 3 conditions, with Laryngeal Disease appearing as the primary indexed condition, and to 2 interventions - of which Triamcinolone Acetonide Injectable Suspension is the first listed.
NCT06634823 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT06634823 about?
NCT06634823 is a clinical study titled "Efficacy of Intramuscular Steroid Injection for Chronic Cough.". 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 patien...
What is the current status of trial NCT06634823?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 40 participants. The study started on 2024-12-02. Estimated completion is 2026-06-30.
What conditions does trial NCT06634823 study?
This clinical trial studies the following conditions: Laryngeal Disease, Chronic Cough (CC), Coughing.
What interventions are being tested in trial NCT06634823?
The interventions under investigation include: Triamcinolone Acetonide Injectable Suspension (DRUG), Saline injection (DRUG).
Who is sponsoring clinical trial NCT06634823?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06634823 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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