CoughPhase 3NCT04421092
Efficacy of SLN Block for Chronic Cough
A Phase 3 study testing Superior laryngeal nerve block and Injection of steroid-lidocaine mixture in people with Cough and Superior Laryngeal Nerve Block, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This is a research study to find out if superior laryngeal nerve blocks are an effective way to reduce cough when compared to placebo (a substance without any medical value). Eligibility for the study include the following: age >18, cough history suggestive that the nerve to the voice box is overactive, non-smoker… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cough, Superior Laryngeal Nerve Block, Neurogenic Cough
- What is being tested?
- Superior laryngeal nerve block and Injection of steroid-lidocaine mixture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2020to 30 Dec 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- History consistent with neurogenic cough
Who cannot join
- Age ≥ 18
- Current neuromodulating medication use
- Untreated other etiologies of cough:
- Current smoker Current ACE/ARB use Abnormal PFTs within 6 months Uncontrolled OSA Abnormal CXR within 6 months RSI > 13 or RFS >11 AND workup positive for GERD (esophagram, 24-hour pH probe, manometry, EGD)
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29403
About this study
Official title: Efficacy of Superior Laryngeal Nerve Block for Chronic Cough
This is a research study to find out if superior laryngeal nerve blocks are an effective way to reduce cough when compared to placebo (a substance without any medical value). Eligibility for the study include the following: age >18, cough history suggestive that the nerve to the voice box is overactive, non-smoker, Patients will be followed over time and assigned to either the treatment or placebo group at random. The treatment would be four superior laryngeal nerve blocks and the placebo would be four saline injections (the inactive substance). Study team will measure if the injection improved cough and ask patients to keep a log of symptoms and fill out questionnaires at each visit. After the four injections, patients will follow up in 3 months to see if cough has returned and if so, how severe the cough is.
- Conditions
- Cough, Superior Laryngeal Nerve Block, Neurogenic Cough
- Being tested
- Superior laryngeal nerve block, Injection of placebo (saline), Injection of steroid-lidocaine mixture
- Keywords
- superior laryngeal nerve block, 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 blockProcedure or surgery
Also called Injection of steroid-lidocaine mixture vs. placebo (saline)
Injection of either the steroid-lidocaine mixture or placebo through the skin around where the superior laryngeal nerve is located on the neck. The procedure lasts 5 minutes and is done in the clinic.
Injection of placebo (saline)Procedure or surgery
Also called 1mL of saline as the injection
Superior laryngeal nerve block using 1mL of saline as the injection.
Injection of steroid-lidocaine mixtureProcedure or surgery
Also called 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection.
Superior laryngeal nerve block using 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection.
| Study group | Role | What they receive |
|---|---|---|
| Steroid-Lidocaine Mixture | Experimental | Will receive numbing injection, which is a mixture of steroid and lidocaine Receives: Procedure: Superior laryngeal nerve block; Procedure: Injection of steroid-lidocaine mixture |
| Placebo | Placebo comparator | Will receive saline injection as a placebo Receives: Procedure: Superior laryngeal nerve block; Procedure: Injection of placebo (saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cough Severity
Patient will complete the Leicester Cough Questionnaire at each visit. This is a validated survey that measures 3 domains (physical, psychological and social). The total score range is 3-21 and domain scores range from 1-7; a higher score indicates a better quality of life.
Measured: Change from Baseline to 3 months
Secondary outcomes (2)
Subjective Improvement in Cough
Improvement was defined as a 'yes' response at any time point during the study (1-4 weeks or 3 months post-treatment). The reported value reflects the total number of participants who reported improvement at any time point.
Measured: Baseline, 1-4 weeks post-injection, and 3 months post-treatment
Summed Daily Change in Subjective Cough Severity
Participants rate cough severity on a 0-15 visual analogue scale. Scores are recorded daily and analyzed using regression. Higher scores indicate greater severity. VAS is a 0-15 scale completed daily by participants.
Severity is measured using a ruler to determine percentage along the scale. Scores were analyzed using regression models to assess trends over time.
Measured: Daily for 3 months post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start22 Jul 2020
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two treatment arms: 1. Treatment Group (n=25) - 2 mL of 1:1 triamcinolone 40:1% lidocaine with 1:2000000 epinephrine. 2. Placebo group (n=25) 2 mL of saline.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Courtney Tipton, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421092
- Sponsor's protocol ID
- 00096384
- Status last verified
- Sep 2025
- First submitted
- 4 Jun 2020
- Last updated
- 23 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Superior Laryngeal Nerve Block for Chronic Cough
- ClinicalTrials.gov ID
- NCT04421092
- Acronym / sponsor ID
- 00096384
- Conditions
- Cough, Superior Laryngeal Nerve Block, Neurogenic Cough
- Keywords
- superior laryngeal nerve block, chronic cough
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Posted 23 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study to find out if superior laryngeal nerve blocks are an effective way to reduce cough when compared to placebo (a substance without any medical value). Eligibility for the study include the following: age >18, cough history suggestive that the nerve to the voice box is overactive, non-smoker, Patients will be followed over time and assigned to either the treatment or placebo group at random. The treatment would be four superior laryngeal nerve blocks and the placebo would be four saline injections (the inactive substance). Study team will measure if the injection improved cough and ask patients to keep a log of symptoms and fill out questionnaires at each visit. After the four injections, patients will follow up in 3 months to see if cough has returned and if so, how severe the cough is.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two treatment arms: 1. Treatment Group (n=25) - 2 mL of 1:1 triamcinolone 40:1% lidocaine with 1:2000000 epinephrine. 2. Placebo group (n=25) 2 mL of saline.
| Arm | Type | Receives |
|---|---|---|
| Steroid-Lidocaine Mixture | Experimental | Procedure: Superior laryngeal nerve block, Procedure: Injection of steroid-lidocaine mixtureWill receive numbing injection, which is a mixture of steroid and lidocaine |
| Placebo | Placebo comparator | Procedure: Superior laryngeal nerve block, Procedure: Injection of placebo (saline)Will receive saline injection as a placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- History consistent with neurogenic cough
Key exclusion criteria (4 listed)
- Age ≥ 18
- Current neuromodulating medication use
- Untreated other etiologies of cough:
- Current smoker Current ACE/ARB use Abnormal PFTs within 6 months Uncontrolled OSA Abnormal CXR within 6 months RSI > 13 or RFS >11 AND workup positive for GERD (esophagram, 24-hour pH probe, manometry, EGD)
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: Injection of steroid-lidocaine mixture vs. placebo (saline)Injection of either the steroid-lidocaine mixture or placebo through the skin around where the superior laryngeal nerve is located on the neck. The procedure lasts 5 minutes and is done in the clinic. | Procedure or surgery | Placebo, Steroid-Lidocaine Mixture |
| Injection of placebo (saline)Also: 1mL of saline as the injectionSuperior laryngeal nerve block using 1mL of saline as the injection. | Procedure or surgery | Placebo |
| Injection of steroid-lidocaine mixtureAlso: 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection.Superior laryngeal nerve block using 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection. | Procedure or surgery | Steroid-Lidocaine Mixture |
Primary outcome
Change in Cough Severity
Time frame: Change from Baseline to 3 months
Patient will complete the Leicester Cough Questionnaire at each visit. This is a validated survey that measures 3 domains (physical, psychological and social). The total score range is 3-21 and domain scores range from 1-7; a higher score indicates a better quality of life.
2 secondary outcomes
Subjective Improvement in Cough
Time frame: Baseline, 1-4 weeks post-injection, and 3 months post-treatment
Summed Daily Change in Subjective Cough Severity
Time frame: Daily for 3 months post-injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Courtney Tipton principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Superior laryngeal nerve block and Injection of steroid-lidocaine mixture in people with Cough and Superior Laryngeal Nerve Block, run by Medical University of South Carolina 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 23 Oct 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cough Severity (time frame: Change from 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 23 Oct 2025.