Laryngeal Nerve Block for Chronic Cough

Prospective, Single-Blind Randomized Trial of in Office Superior Laryngeal Nerve Block for the Treatment of Chronic Neurogenic Cough

The purpose of this study is to study the potential benefit of treating chronic neurogenic cough by blocking the nerve responsible for the disease with an injection of local anesthetic/steroid mixture versus a placebo.

Study Overview

• Status: Recruiting
• Conditions: Laryngeal Nerve Block; Chronic Neurogenic Cough; Laryngeal Hypersensitivity
• Intervention / Treatment: Drug: Steroid/Anesthesia Mixture; Drug: Placebo

Detailed Description

This study will be performed by asking participants to fill out multiple questionnaires on the symptoms of their cough, and undergo cough testing by inhaling an airway irritant and monitoring the number of coughs after inhalation of the irritant. Subjects would then undergo the treatment and have an injection of either local anesthetic/steroid mixture or a placebo (normal saline) around the nerve that gives feeling to the portion of the voice box responsible for chronic neurogenic cough. After the injection you will be asked to repeat the cough testing and questionnaires 30 minutes, 1 weeks, and at 6 weeks post injection. After the initial six weeks, patients will cross over and repeat the same process with the opposite treatment (either local anesthetic/steroid mixture or placebo) from their previous injection. The total time of participation is about 12 weeks and we hope to recruit 40 subjects.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Recruiting
      • Eastern Virginia Medical School Ear, Nose, and Throat Surgeons
      • Sub-Investigator: Michael Larson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years and older
• Previously or Newly Diagnosed Chronic Neurogenic Cough

Exclusion Criteria:

• History of Laryngeal Surgery or External Beam Radiation
• Current Smokers
• Known Allergy or Sensitivity to Local Anesthetics
• Uncontrolled Pulmonary, SinoNasal, or GastroIntestinal Pathology leading to Refractory Chronic Cough

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention (Steroid/Anesthetic Mixture); The steroid/anesthetic mixture will be injected via a 27-gauge needle once at the baseline or during the 6-week crossover timepoint.	Drug: Steroid/Anesthesia Mixture; Steroid will be Triamcinolone Acetonide (40mg/mL). Anesthetic will be 0.5% bupivacaine with 1:100,000 epinephrine. These will be pre-mixed by a qualified personnel within the ENT department.
PLACEBO_COMPARATOR: Placebo (Normal Saline); The placebo (Normal Saline) will be injected via a 27-gauge needle once at the baseline or during the 6-week crossover timepoint.	Drug: Placebo; 2 mL of Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention vs. Placebo in Neurogenic Cough using Capsaicin Challenge	Objectively evaluate the efficacy of blockade of the internal branch of the superior laryngeal nerve with local anesthetic/steroid mixture compared to normal saline placebo in treating chronic neurogenic cough using capsaicin challenge testing to measure cough sensitivity and urge to cough	Comparing Changes at Pretreatment, at 30 minutes post treatment, at 1 week post treatment, and at 6 weeks post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention vs. Placebo in Neurogenic Cough using the Newcastle Laryngeal Hypersensitivity Questionnaire	Subjectively evaluate the efficacy of superior laryngeal nerve block (intervention) vs. placebo using the Newcastle Laryngeal Hypersensitivity Questionnaire (NLHQ). This Questionnaire is scaled from 1 to 7. 1 indicates All of the Time while 7 reflects None of the Time.	Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment
Intervention vs. Placebo in Neurogenic Cough using the Urge to Cough Scale	Subjectively evaluate the efficacy of superior laryngeal nerve block (intervention) vs. placebo using the Urge to Cough Scale. Higher score indicates more urge, while lower score reflects less of an urge to cough.	Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment
Intervention vs. Placebo in Neurogenic Cough using the Central Sensitization Inventory	Subjectively evaluate the efficacy of superior laryngeal nerve block (intervention) vs. placebo using the Central Sensitization Inventory (CSI). Scale is ranked as Never, Rarely, Sometimes, Often, and Always and has various symptoms listed.	Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment
Quality of Life Measurements	Analyze quality of life measurements of patients undergoing superior laryngeal nerve block compared to placebo as measured by the Leicester Cough Questionnaire (LCQ). Scale is from a 1 to 7. The higher the score/rating represents less of a problem while a lower score/rating represents more of a problem.	Pretreatment, 1 week post treatment, 6 weeks post treatment

Collaborators and Investigators

• Sponsor: Eastern Virginia Medical School

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 21, 2021
• Primary Completion (ANTICIPATED): June 25, 2023
• Study Completion (ANTICIPATED): June 25, 2023

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (ACTUAL): March 23, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: cough; chronic cough; neurogenic cough; laryngeal nerve block
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Hypersensitivity; Cough; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 14Jul2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No