Superior Laryngeal Nerve Block for Chronic Cough

Overseen By Courtney Tipton, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Medical University of South Carolina

Must not be taking: Neuromodulating medications, ACE/ARB

Disqualifiers: Current smoker, Abnormal PFTs, Uncontrolled OSA, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special injection, called a superior laryngeal nerve block, can effectively reduce chronic cough. Participants will be randomly assigned to receive either the nerve block or a placebo (an inactive substance, specifically a saline injection) to compare outcomes. It targets non-smokers over 18 with a history of a nerve-related cough that disrupts daily life. The study involves four injections and requires participants to track symptoms in a log and through questionnaires. After the injections, participants will have a follow-up in three months to assess the return and severity of the cough. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

If you are currently using neuromodulating medications, you will need to stop taking them to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that injections near the voice box, known as superior laryngeal nerve blocks, are generally safe for treating chronic cough. In studies, most patients benefited from these treatments without serious issues.

Some patients experienced mild side effects, such as temporary numbness in the throat, which resolved within a day. This nerve block uses a combination of a steroid and lidocaine. Steroids reduce swelling, while lidocaine numbs the area.

New evidence suggests that this mixture is safe and can help lessen cough symptoms. The reviewed research found no serious complications, which is reassuring for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike other treatments for chronic cough, which often rely on medications like cough suppressants and expectorants, the investigational treatments in this trial focus on nerve blocking techniques. The steroid-lidocaine mixture offers a unique approach by combining a numbing agent with an anti-inflammatory steroid, potentially providing rapid relief by directly targeting the nerves involved in the cough reflex. Meanwhile, the Superior Laryngeal Nerve Block represents a novel method that could interrupt the transmission of cough signals altogether, offering a potentially more effective solution for those who haven't found relief with standard medications. Researchers are excited about these treatments because they could offer faster and more targeted relief for individuals suffering from chronic cough, addressing the condition at its source rather than merely managing symptoms.

What evidence suggests that superior laryngeal nerve blocks are effective for reducing cough?

Research has shown that the superior laryngeal nerve block, which involves injecting a mix of steroids and lidocaine, effectively treats chronic cough. In this trial, participants will receive either a steroid-lidocaine mixture or a placebo saline injection. Studies have found that patients who received the steroid-lidocaine mixture experienced a significant reduction in cough severity. Specifically, one study revealed that 75% of patients reported improvement after at least one injection, with an average improvement rate of 73%. Long-term follow-up indicated that more than half of the patients who initially responded well continued to have fewer symptoms for 6 to 9 months. Overall, this treatment shows promise for reducing chronic cough symptoms by calming the overly active nerve. ^{1 2 3 4 6}

Who Is on the Research Team?

Courtney Tipton

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

Inclusion Criteria

Exclusion of other etiologies (see

History consistent with neurogenic cough

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive four superior laryngeal nerve blocks or four saline injections as a placebo

8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including symptom logs and questionnaires

3 months

Every two weeks (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Injection of placebo (saline)
• Injection of steroid-lidocaine mixture
• Superior Laryngeal Nerve Block

How Is the Trial Designed?

Group I: Steroid-Lidocaine Mixture Experimental Treatment 2 Interventions

Will receive numbing injection, which is a mixture of steroid and lidocaine

Group II: Placebo Placebo Group 2 Interventions

Will receive saline injection as a placebo

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6703134/

Superior laryngeal nerve block for neurogenic cough Results. We find that all patients in this study that underwent an SLN block showed significant improvement in cough severity index (CSI). The ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/lary.70011

Prospective Study of Long‐Term Outcomes and the Patient ... Of the initial improvers, 53.2% reported ongoing symptom improvement at long-term follow-up (6–9 months). Improvement occurred at an average of ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0196070924003545

Bilateral internal superior laryngeal nerve injections for ... 75 % of patients reported improvement with at least one of their injections with a median percentage response of 73 % (IQR: 26–89 %) and a reported median ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7890738/

Longitudinal Follow-up of Superior Laryngeal Nerve Block ... Superior laryngeal nerve block is an effective long-term treatment for neurogenic cough. No additional treatment was required within 10 months of the SLN block.

5. withpower.com withpower.com/trial/phase-3-cough-6-2020-d744b

Efficacy of SLN Block for Chronic Cough · Info for Participants Research shows that the superior laryngeal nerve block, which involves injecting a mixture of steroids and lidocaine, has been effective in treating neurogenic ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/lary.31061

The Role of Bilateral Superior Laryngeal Nerve Block in ... The mode and median weeks improvement for symptom relief between injections were both 4 weeks. Subgroup Analysis. A total of 111 patients ...