Laryngeal Nerve Block for Chronic Cough

NCT ID: NCT05292677

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-21
• Study Completion Date: 2023-06-25

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.

Detailed Description

This study will be performed by asking participants to fill out multiple questionnaires on the symptoms of their cough, and undergo cough testing by inhaling an airway irritant and monitoring the number of coughs after inhalation of the irritant. Subjects would then undergo the treatment and have an injection of either local anesthetic/steroid mixture or a placebo (normal saline) around the nerve that gives feeling to the portion of the voice box responsible for chronic neurogenic cough. After the injection you will be asked to repeat the cough testing and questionnaires 30 minutes, 1 weeks, and at 6 weeks post injection. After the initial six weeks, patients will cross over and repeat the same process with the opposite treatment (either local anesthetic/steroid mixture or placebo) from their previous injection. The total time of participation is about 12 weeks and we hope to recruit 40 subjects.

Conditions

Laryngeal Nerve Block; Chronic Neurogenic Cough; Laryngeal Hypersensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention (Steroid/Anesthetic Mixture)

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

Group Type: EXPERIMENTAL

Steroid/Anesthesia Mixture

Intervention Type: DRUG

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.

Placebo (Normal Saline)

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

2 mL of Normal Saline

Interventions

Steroid/Anesthesia Mixture

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 Type: DRUG

Placebo

2 mL of Normal Saline

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastern Virginia Medical School

OTHER

Sponsor Role: lead

Responsible Party

Benjamin J Rubinstein

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin Rubinstein, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Eastern Virginia Medical School Ear, Nose, and Throat Surgeons

Norfolk, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Addy Tham, MS

Role: CONTACT

thama@evms.edu

757.388.6264

Laura Stone, RN

Role: CONTACT

stonelj@evms.edu

757.388.6238

Facility Contacts

Addy Tham, MS

Role: primary

thama@evms.edu

757-388-6264

Laura Stone, RN

Role: backup

stonelj@evms.edu

757.388.6238

Other Identifiers

14Jul2021

Identifier Type: -

Identifier Source: org_study_id