Efficacy of SLN Block for Chronic Cough

Cough Clinical Trial

Official title:

Efficacy of Superior Laryngeal Nerve Block for Chronic Cough

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04421092
• Other study ID #: 00096384
• Status: Completed
• Phase: Phase 2
• Start date: July 22, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: April 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cough
• Neurogenic Cough
• Superior Laryngeal Nerve Block

Intervention

Procedure:
• Superior laryngeal nerve block
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.
• Injection of placebo (saline)
Superior laryngeal nerve block using 1mL of saline as the injection.
• Injection of steroid-lidocaine mixture
Superior laryngeal nerve block using 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, every two weeks (+/- 1 week) post-treatment (estimated 3 months total)
Secondary	Subjective improvement in cough	Patient will state dichotomously "yes" or "no" if cough overall improved at each visit.	Every two weeks (+/- 1 week) post-treatment (estimated 3 months total), 3 months post completion of therapy
Secondary	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.	Daily after each treatment (estimated 3 months total)