Clinical trial NCT05292677: Laryngeal Nerve Block for Chronic Cough
Official title: Prospective, Single-Blind Randomized Trial of in Office Superior Laryngeal Nerve Block for the Treatment of Chronic Neurogenic Cough
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Laryngeal Nerve Block
Chronic Neurogenic Cough
Laryngeal Hypersensitivity
Keywords: cough
chronic cough
neurogenic cough
laryngeal nerve block
Lead sponsor: Eastern Virginia Medical School
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Intervention vs. Placebo in Neurogenic Cough using Capsaicin Challenge
timeFrame: Comparing Changes at Pretreatment, at 30 minutes post treatment, at 1 week post treatment, and at 6 weeks post treatment
Secondary outcomes:
measure: Intervention vs. Placebo in Neurogenic Cough using the Newcastle Laryngeal Hypersensitivity Questionnaire
timeFrame: Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment
measure: Intervention vs. Placebo in Neurogenic Cough using the Urge to Cough Scale
timeFrame: Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment
measure: Intervention vs. Placebo in Neurogenic Cough using the Central Sensitization Inventory
timeFrame: Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment
measure: Quality of Life Measurements
timeFrame: Pretreatment, 1 week post treatment, 6 weeks post treatment
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Eastern Virginia Medical School Ear, Nose, and Throat Surgeons
state: Virginia
Study officials:
affiliation: Eastern Virginia Medical School Department of Otolaryngology - Head and Neck Surgery
name: Benjamin Rubinstein, MD
role: PRINCIPAL_INVESTIGATOR
References: