NCT05292677

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 23, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2023

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

1.9 years

First QC Date

September 14, 2021

Last Update Submit

March 14, 2022

Conditions

Laryngeal Nerve BlockChronic Neurogenic CoughLaryngeal Hypersensitivity

Keywords

coughchronic coughneurogenic coughlaryngeal nerve block

Outcome Measures

Primary Outcomes (1)

  • 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

    Comparing Changes at Pretreatment, at 30 minutes post treatment, at 1 week post treatment, and at 6 weeks post treatment

Secondary Outcomes (4)

  • Intervention vs. Placebo in Neurogenic Cough using the Newcastle Laryngeal Hypersensitivity Questionnaire

    Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment

  • Intervention vs. Placebo in Neurogenic Cough using the Urge to Cough Scale

    Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment

  • Intervention vs. Placebo in Neurogenic Cough using the Central Sensitization Inventory

    Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment

  • Quality of Life Measurements

    Pretreatment, 1 week post treatment, 6 weeks post treatment

Study Arms (2)

Intervention (Steroid/Anesthetic Mixture)

EXPERIMENTAL

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

Drug: Steroid/Anesthesia Mixture

Placebo (Normal Saline)

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Steroid/Anesthesia MixtureDRUG

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 (Steroid/Anesthetic Mixture)
PlaceboDRUG

2 mL of Normal Saline

Placebo (Normal Saline)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • Previously or Newly Diagnosed Chronic Neurogenic Cough

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Virginia Medical School Ear, Nose, and Throat Surgeons

Norfolk, Virginia, 23507, United States

RECRUITING

MeSH Terms

Conditions

CoughChronic Cough

Interventions

Steroids

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Benjamin Rubinstein, MD

    Eastern Virginia Medical School Department of Otolaryngology - Head and Neck Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Addy Tham, MS

CONTACT

757.388.6264thama@evms.edu

Laura Stone, RN

CONTACT

757.388.6238stonelj@evms.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 14, 2021

First Posted

March 23, 2022

Study Start

July 21, 2021

Primary Completion

June 25, 2023

Study Completion

June 25, 2023

Last Updated

March 23, 2022

Record last verified: 2022-03

Locations

US(1)