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Laryngeal Nerve Block for Chronic Cough

Primary Purpose

Laryngeal Nerve Block, Chronic Neurogenic Cough, Laryngeal Hypersensitivity

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Steroid/Anesthesia Mixture
Placebo
Sponsored by
Eastern Virginia Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laryngeal Nerve Block focused on measuring cough, chronic cough, neurogenic cough, laryngeal nerve block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eastern Virginia Medical School Ear, Nose, and Throat SurgeonsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention (Steroid/Anesthetic Mixture)

Placebo (Normal Saline)

Arm Description

The steroid/anesthetic mixture will be injected via a 27-gauge needle once at the baseline or during the 6-week crossover timepoint.

The placebo (Normal Saline) will be injected via a 27-gauge needle once at the baseline or during the 6-week crossover timepoint.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
September 14, 2021
Last Updated
March 14, 2022
Sponsor
Eastern Virginia Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT05292677
Brief Title
Laryngeal Nerve Block for Chronic Cough
Official Title
Prospective, Single-Blind Randomized Trial of in Office Superior Laryngeal Nerve Block for the Treatment of Chronic Neurogenic Cough
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2021 (Actual)
Primary Completion Date
June 25, 2023 (Anticipated)
Study Completion Date
June 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Virginia Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngeal Nerve Block, Chronic Neurogenic Cough, Laryngeal Hypersensitivity
Keywords
cough, chronic cough, neurogenic cough, laryngeal nerve block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention (Steroid/Anesthetic Mixture)
Arm Type
Experimental
Arm Description
The steroid/anesthetic mixture will be injected via a 27-gauge needle once at the baseline or during the 6-week crossover timepoint.
Arm Title
Placebo (Normal Saline)
Arm Type
Placebo Comparator
Arm Description
The placebo (Normal Saline) will be injected via a 27-gauge needle once at the baseline or during the 6-week crossover timepoint.
Intervention Type
Drug
Intervention Name(s)
Steroid/Anesthesia Mixture
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 mL of Normal Saline
Primary Outcome Measure Information:
Title
Intervention vs. Placebo in Neurogenic Cough using Capsaicin Challenge
Description
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
Time Frame
Comparing Changes at Pretreatment, at 30 minutes post treatment, at 1 week post treatment, and at 6 weeks post treatment
Secondary Outcome Measure Information:
Title
Intervention vs. Placebo in Neurogenic Cough using the Newcastle Laryngeal Hypersensitivity Questionnaire
Description
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.
Time Frame
Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment
Title
Intervention vs. Placebo in Neurogenic Cough using the Urge to Cough Scale
Description
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.
Time Frame
Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment
Title
Intervention vs. Placebo in Neurogenic Cough using the Central Sensitization Inventory
Description
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.
Time Frame
Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment
Title
Quality of Life Measurements
Description
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.
Time Frame
Pretreatment, 1 week post treatment, 6 weeks post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Addy Tham, MS
Phone
757.388.6264
Email
thama@evms.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Stone, RN
Phone
757.388.6238
Email
stonelj@evms.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Rubinstein, MD
Organizational Affiliation
Eastern Virginia Medical School Department of Otolaryngology - Head and Neck Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastern Virginia Medical School Ear, Nose, and Throat Surgeons
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Addy Tham, MS
Phone
757-388-6264
Email
thama@evms.edu
First Name & Middle Initial & Last Name & Degree
Laura Stone, RN
Phone
757.388.6238
Email
stonelj@evms.edu
First Name & Middle Initial & Last Name & Degree
Benjamin Rubinstein, MD
First Name & Middle Initial & Last Name & Degree
John Sinacori, MD
First Name & Middle Initial & Last Name & Degree
Michael Larson, MD

12. IPD Sharing Statement

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Laryngeal Nerve Block for Chronic Cough

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