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Efficacy of SLN Block for Chronic Cough

Primary Purpose

Cough, Superior Laryngeal Nerve Block, Neurogenic Cough

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Superior laryngeal nerve block
Injection of placebo (saline)
Injection of steroid-lidocaine mixture
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cough focused on measuring superior laryngeal nerve block, chronic cough

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • History consistent with neurogenic cough
  • Exclusion of other etiologies (see exclusion criteria)
  • Age ≥ 18

Exclusion Criteria:

  • 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)

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Steroid-Lidocaine Mixture

Placebo

Arm Description

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

Will receive saline injection as a placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Subjective improvement in cough
Patient will state dichotomously "yes" or "no" if cough overall improved at each visit.
Daily change in subjective cough severity
Patient will fill out a Visual Analogue Scale measuring cough severity. Patients will be given a log to complete daily after treatment completed and instructed to mark on a line with a "X" how severe the cough is. The far left of the line will indicate no cough at all, and the far right is indicative of the most severe cough.

Full Information

First Posted
June 4, 2020
Last Updated
April 21, 2023
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT04421092
Brief Title
Efficacy of SLN Block for Chronic Cough
Official Title
Efficacy of Superior Laryngeal Nerve Block for Chronic Cough
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 22, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Steroid-Lidocaine Mixture
Arm Type
Experimental
Arm Description
Will receive numbing injection, which is a mixture of steroid and lidocaine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Will receive saline injection as a placebo
Intervention Type
Procedure
Intervention Name(s)
Superior laryngeal nerve block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Injection of placebo (saline)
Intervention Description
Superior laryngeal nerve block using 1mL of saline as the injection.
Intervention Type
Procedure
Intervention Name(s)
Injection of steroid-lidocaine mixture
Intervention Description
Superior laryngeal nerve block using 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection.
Primary Outcome Measure Information:
Title
Change in cough severity
Description
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.
Time Frame
Baseline, every two weeks (+/- 1 week) post-treatment (estimated 3 months total)
Secondary Outcome Measure Information:
Title
Subjective improvement in cough
Description
Patient will state dichotomously "yes" or "no" if cough overall improved at each visit.
Time Frame
Every two weeks (+/- 1 week) post-treatment (estimated 3 months total), 3 months post completion of therapy
Title
Daily change in subjective cough severity
Description
Patient will fill out a Visual Analogue Scale measuring cough severity. Patients will be given a log to complete daily after treatment completed and instructed to mark on a line with a "X" how severe the cough is. The far left of the line will indicate no cough at all, and the far right is indicative of the most severe cough.
Time Frame
Daily after each treatment (estimated 3 months total)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: History consistent with neurogenic cough Exclusion of other etiologies (see exclusion criteria) Age ≥ 18 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Courtney Tipton
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of SLN Block for Chronic Cough

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