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Clinical Trials/NCT04421092
NCT04421092
Completed
Phase 3

Efficacy of Superior Laryngeal Nerve Block for Chronic Cough

Medical University of South Carolina1 site in 1 country17 target enrollmentJuly 22, 2020

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Cough
Sponsor
Medical University of South Carolina
Enrollment
17
Locations
1
Primary Endpoint
Change in Cough Severity
Status
Completed
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 22, 2020
End Date
December 30, 2022
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

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)

Outcomes

Primary Outcomes

Change in Cough Severity

Time Frame: Change from Baseline to 3 months

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 Outcomes

  • Subjective Improvement in Cough(Baseline, 1-4 weeks post-injection, and 3 months post-treatment)
  • Summed Daily Change in Subjective Cough Severity(Daily for 3 months post-injection)

Study Sites (1)

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