Efficacy of SLN Block for Chronic Cough

Phase 2

Completed

• Conditions: Superior Laryngeal Nerve Block; Cough; Neurogenic Cough
• Interventions: Procedure: Superior laryngeal nerve block; Procedure: Injection of steroid-lidocaine mixture; Procedure: Injection of placebo (saline)

• Registration Number: NCT04421092
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-09
• Study Start: 2020-07-22
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-21
• Last Update Posted: 2023-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Steroid-Lidocaine Mixture	Injection of steroid-lidocaine mixture	Will receive numbing injection, which is a mixture of steroid and lidocaine
Steroid-Lidocaine Mixture	Superior laryngeal nerve block	Will receive numbing injection, which is a mixture of steroid and lidocaine
Placebo	Injection of placebo (saline)	Will receive saline injection as a placebo
Placebo	Superior laryngeal nerve block	Will receive saline injection as a placebo

Primary Outcome Measures

Name	Time	Method
Change in cough severity	Baseline, every two weeks (+/- 1 week) post-treatment (estimated 3 months total)	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

Name	Time	Method
Daily change in subjective cough severity	Daily after each treatment (estimated 3 months total)	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.
Subjective improvement in cough	Every two weeks (+/- 1 week) post-treatment (estimated 3 months total), 3 months post completion of therapy	Patient will state dichotomously "yes" or "no" if cough overall improved at each visit.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States