CoughNCT04642352
Office-Based Superior Laryngeal Nerve Block for Treatment of Neurogenic Cough
An observational study of Cough, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cough
- What is being tested?
- superior laryngeal nerve block
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2022to Jun 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to UAB Department of Otolaryngology for the evaluation and treatment of chronic cough who would be undergoing superior laryngeal nerve block as part of their standard clinical care.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Blake Simpson, MD, (205) 801-7864, blakesimpson@uabmc.edu
About this study
Official title: Office-Based Superior Laryngeal Nerve (SLN) Block for Treatment of Neurogenic Cough
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.
Read the detailed description
Neurogenic cough is a chronic cough without a clear cause. It is thought to be related to irritation of a nerve that goes to the larynx (voice box). This can happen after a viral upper respiratory infection. Current treatment uses therapy or medications taken by mouth. Those medications can be sedating and not well tolerated. An alternative approach would be to perform an injection "nerve block", which is commonly done for other nerve disorders such as around the spine. This may help people with neurogenic cough also. We studied this recently in a small group of patients and found that patients had improvement in their cough symptoms (Simpson 2018). It would be helpful to study this in a larger group of patients using more methods of evaluating cough symptom severity.
- Conditions
- Cough
- Being tested
- superior laryngeal nerve block
- Keywords
- chronic cough
- Medical subject headings
- Cough, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
superior laryngeal nerve blockDrug
Also called 0.25% bupivacaine, Kenalog-40
A unilateral injection of 2 cc of a 1:1 mixture of 0.25% bupivacaine and Kenalog-40 via a 27 gauge needle to the thyrohyoid space (front of neck, just above larynx/voice box) via a 27 gauge needle to the thyrohyoid space (front of neck, just above larynx/voice box) on the side which exhibited most discomfort/tenderness/cough on palpation. If neither side was uncomfortable, the right side will be used.
| Study group | Role | What they receive |
|---|---|---|
| SLN intervention group | Participants will undergo a superior laryngeal nerve (SLN) block Receives: Drug: superior laryngeal nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score on the Leicester Cough Questionnaire
The Leicester Cough Questionnaire consists of 19 questions designed to assess the impact of cough on various aspects of a participant's quality of life. Scores are chosen from a Likert scale from 1 to 7, with 1 representing "all of the time" and 7 representing "none of the time." Scores would decrease if symptoms improved.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start3 Jan 2022
- Primary completionJun 2031 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blake Simpson, University of Alabama at Birmingham
- Investigators
- Blake Simpson, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642352
- Sponsor's protocol ID
- IRB-300005783
- Other IDs
- UAB
- Status last verified
- Apr 2026
- First submitted
- 19 Nov 2020
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Office-Based Superior Laryngeal Nerve (SLN) Block for Treatment of Neurogenic Cough
- ClinicalTrials.gov ID
- NCT04642352
- Acronym / sponsor ID
- IRB-300005783
- Conditions
- Cough
- Keywords
- chronic cough
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 24 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Neurogenic cough is a chronic cough without a clear cause. It is thought to be related to irritation of a nerve that goes to the larynx (voice box). This can happen after a viral upper respiratory infection. Current treatment uses therapy or medications taken by mouth. Those medications can be sedating and not well tolerated. An alternative approach would be to perform an injection "nerve block", which is commonly done for other nerve disorders such as around the spine. This may help people with neurogenic cough also. We studied this recently in a small group of patients and found that patients had improvement in their cough symptoms (Simpson 2018). It would be helpful to study this in a larger group of patients using more methods of evaluating cough symptom severity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SLN intervention group | – | Drug: superior laryngeal nerve blockParticipants will undergo a superior laryngeal nerve (SLN) block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to UAB Department of Otolaryngology for the evaluation and treatment of chronic cough who would be undergoing superior laryngeal nerve block as part of their standard clinical care.
Key inclusion criteria (8 listed)
- 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):
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| superior laryngeal nerve blockAlso: 0.25% bupivacaine, Kenalog-40A unilateral injection of 2 cc of a 1:1 mixture of 0.25% bupivacaine and Kenalog-40 via a 27 gauge needle to the thyrohyoid space (front of neck, just above larynx/voice box) via a 27 gauge needle to the thyrohyoid space (front of neck, just above larynx/voice box) on the side which exhibited most discomfort/tenderness/cough on palpation. If neither side was uncomfortable, the right side will be used. | Drug | SLN intervention group |
Primary outcome
Change in score on the Leicester Cough Questionnaire
Time frame: Baseline to 3 months
The Leicester Cough Questionnaire consists of 19 questions designed to assess the impact of cough on various aspects of a participant's quality of life. Scores are chosen from a Likert scale from 1 to 7, with 1 representing "all of the time" and 7 representing "none of the time." Scores would decrease if symptoms improved.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Blake Simpson, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cough, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Blake Simpson, MD ((205) 801-7863, blakesimpson@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in score on the Leicester Cough Questionnaire (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.