Efficacy of SLN Block for Chronic Cough

NCT04421092 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 00096384
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This is a research study to find out if superior laryngeal nerve blocks are an effective way to reduce cough when compared to placebo (a substance without any medical value). Eligibility for the study include the following: age \>18, cough history suggestive that the nerve to the voice box is overactive, non-smoker, Patients will be followed over time and assigned to either the treatment or placebo group at random. The treatment would be four superior laryngeal nerve blocks and the placebo would be four saline injections (the inactive substance). Study team will measure if the injection improved cough and ask patients to keep a log of symptoms and fill out questionnaires at each visit. After the four injections, patients will follow up in 3 months to see if cough has returned and if so, how severe the cough is.

Conditions

Cough; Superior Laryngeal Nerve Block; Neurogenic Cough

Keywords

superior laryngeal nerve block; chronic cough

Outcome Measures

Primary Outcomes (1)

• Change in Cough Severity

  Patient will complete the Leicester Cough Questionnaire at each visit. This is a validated survey that measures 3 domains (physical, psychological and social). The total score range is 3-21 and domain scores range from 1-7; a higher score indicates a better quality of life.

  Change from Baseline to 3 months

Secondary Outcomes (2)

• Subjective Improvement in Cough

  Baseline, 1-4 weeks post-injection, and 3 months post-treatment

• Summed Daily Change in Subjective Cough Severity

  Daily for 3 months post-injection

Study Arms (2)

Steroid-Lidocaine Mixture

EXPERIMENTAL

Will receive numbing injection, which is a mixture of steroid and lidocaine

Procedure: Superior laryngeal nerve block; Procedure: Injection of steroid-lidocaine mixture

Placebo

PLACEBO COMPARATOR

Will receive saline injection as a placebo

Procedure: Superior laryngeal nerve block; Procedure: Injection of placebo (saline)

Interventions

Superior laryngeal nerve block PROCEDURE

Injection of either the steroid-lidocaine mixture or placebo through the skin around where the superior laryngeal nerve is located on the neck. The procedure lasts 5 minutes and is done in the clinic.

Also known as: Injection of steroid-lidocaine mixture vs. placebo (saline)

Placebo; Steroid-Lidocaine Mixture

Injection of placebo (saline) PROCEDURE

Superior laryngeal nerve block using 1mL of saline as the injection.

Also known as: 1mL of saline as the injection

Placebo

Injection of steroid-lidocaine mixture PROCEDURE

Superior laryngeal nerve block using 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection.

Also known as: 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection.

Steroid-Lidocaine Mixture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History consistent with neurogenic cough

You may not qualify if:

• Age ≥ 18
• Current neuromodulating medication use
• Untreated other etiologies of cough:
• Current smoker Current ACE/ARB use Abnormal PFTs within 6 months Uncontrolled OSA Abnormal CXR within 6 months RSI \> 13 or RFS \>11 AND workup positive for GERD (esophagram, 24-hour pH probe, manometry, EGD)

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

MeSH Terms

Conditions

Cough; Chronic Cough

Interventions

Sodium Chloride; Triamcinolone; Lidocaine; Epinephrine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Shaun A. Nguyen, MD - Director of Clinical Research
• Organization: Medical University of South Carolina - Department of Otolaryngology

nguyensh@musc.edu

8437921356

Study Officials

• Courtney Tipton

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two treatment arms: 1. Treatment Group (n=25) - 2 mL of 1:1 triamcinolone 40:1% lidocaine with 1:2000000 epinephrine. 2. Placebo group (n=25) 2 mL of saline.

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: July 22, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: October 23, 2025
• Results First Posted: October 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)