Laryngeal Nerve Block for Chronic Cough

Eastern Virginia Medical School (EVMS)

Status and phase: Unknown; Phase 4

Conditions: Chronic Neurogenic Cough; Laryngeal Hypersensitivity; Laryngeal Nerve Block

Treatments: Drug: Steroid/Anesthesia Mixture; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05292677

14Jul2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Intervention (Steroid/Anesthetic Mixture)

Experimental group

Description:

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

Treatment:

Drug: Steroid/Anesthesia Mixture

Placebo (Normal Saline)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo