Laryngeal Nerve Block for Chronic Cough

Phase 4

• Conditions: Laryngeal Nerve Block; Chronic Neurogenic Cough; Laryngeal Hypersensitivity
• Interventions: Drug: Steroid/Anesthesia Mixture; Drug: Placebo

• Registration Number: NCT05292677
• Lead Sponsor: Eastern Virginia Medical School

Brief Summary

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.

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 Timeline

• Study Start: 2021-07-21
• Study First Submitted: 2021-09-14
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-14
• Last Update Submitted: 2022-03-14
• Study First Posted: 2022-03-23
• Last Update Posted: 2022-03-23
• Primary Completion: 2023-06-25
• Study Completion: 2023-06-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention (Steroid/Anesthetic Mixture)	Steroid/Anesthesia Mixture	The steroid/anesthetic mixture will be injected via a 27-gauge needle once at the baseline or during the 6-week crossover timepoint.
Placebo (Normal Saline)	Placebo	The placebo (Normal Saline) will be injected via a 27-gauge needle once at the baseline or during the 6-week crossover timepoint.

Primary Outcome Measures

Name	Time	Method
Intervention vs. Placebo in Neurogenic Cough using Capsaicin Challenge	Comparing Changes at Pretreatment, at 30 minutes post treatment, at 1 week post treatment, and at 6 weeks post treatment	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

Secondary Outcome Measures

Name	Time	Method
Intervention vs. Placebo in Neurogenic Cough using the Urge to Cough Scale	Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment	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.
Intervention vs. Placebo in Neurogenic Cough using the Central Sensitization Inventory	Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment	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.
Quality of Life Measurements	Pretreatment, 1 week post treatment, 6 weeks post treatment	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.
Intervention vs. Placebo in Neurogenic Cough using the Newcastle Laryngeal Hypersensitivity Questionnaire	Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment	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.

Trial Locations

Locations (1)

Eastern Virginia Medical School Ear, Nose, and Throat Surgeons; 🇺🇸 Norfolk, Virginia, United States