NCT04642352 Office-Based Superior Laryngeal Nerve Block for Treatment of Neurogenic Cough
| NCT ID | NCT04642352 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Cough |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-01-03 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2022-01-03 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate if office-based injection of a local anesthetic/steroid combination at the area of one superior laryngeal nerve can decrease cough frequency and alleviate symptoms of chronic cough in patients with neurogenic cough.
Eligibility Criteria
Inclusion Criteria: * Age 18 years or older * Ability of patients to speak and understand English * Ability for patients to consent for themselves * Cough for 8 weeks or greater, with suspected sensory neuropathic etiology of the cough. Inclusion based on history of preceding upper respiratory infection or other symptoms suggestive of irritable larynx such as cough in response to temperature changes, odors, scents/perfumes, tickle, irritation in the throat/paralaryngeal region, or talking. * Persistent cough despite treatment of ALL the major contributors of cough (items listed below would be done as part of a standard clinical workup for chronic cough and are not done specific to this study): * Reflux disease treatment with one of the following: failure of two months of PPIs OR negative pH study * Asthma: lack of response to at least one month of steroid inhaler/bronchodilator OR normal PFTs/negative methacholine challenge + negative CXR/CT * Upper airway cough syndrome/Allergic disease: lack of response to at least one month of antihistamines/decongestants/nasal steroids OR negative allergy testing (skin or serum) OR lack of response to at least one year of immunotherapy/allergy shots Exclusion Criteria: * Age less than 18 years * Patients unable or unwilling to provide informed consent * Known etiology to cough other than sensory neuropathy (e.g., reflux disease, asthma, allergic rhinitis, chronic obstructive pulmonary disease) * Addition of new neuromodulators at the time of the injection. Patients who were already being treated with neuromodulators for their cough (e.g., gabapentin, amitriptyline) will not be excluded provided their dose remains constant. * Nissen fundoplication within the last year * Smoking history within last 5 years * Allergy to bupivacaine or Kenalog-40
Contact & Investigator
Blake Simpson, MD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT04642352 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cough. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04642352 currently recruiting?
Yes, NCT04642352 is actively recruiting participants. Contact the research team at blakesimpson@uabmc.edu for enrollment information.
Where is the NCT04642352 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT04642352 clinical trial?
NCT04642352 is sponsored by University of Alabama at Birmingham. The principal investigator is Blake Simpson, MD at University of Alabama at Birmingham. The trial plans to enroll 50 participants.