Laryngeal Nerve BlockPhase 4NCT05292677
Laryngeal Nerve Block for Chronic Cough
A Phase 4 study testing Steroid/Anesthesia Mixture in people with Laryngeal Nerve Block and Chronic Neurogenic Cough, run by Eastern Virginia Medical School at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngeal Nerve Block, Chronic Neurogenic Cough, Laryngeal Hypersensitivity
- What is being tested?
- Steroid/Anesthesia Mixture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2021to 25 Jun 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
Who may be able to join
- 18 years and older
- Previously or Newly Diagnosed Chronic Neurogenic Cough
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Eastern Virginia Medical School Ear, Nose, and Throat Surgeons
Norfolk, Virginia, 23507
Addy Tham, MS, 757-388-6264, thama@evms.edu
Laura Stone, RN, 757.388.6238, stonelj@evms.edu
About this study
Official title: Prospective, Single-Blind Randomized Trial of in Office Superior Laryngeal Nerve Block for the Treatment of Chronic Neurogenic Cough
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.
Read the 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.
- Being tested
- Steroid/Anesthesia Mixture, Placebo
- Keywords
- cough, chronic cough, neurogenic cough, laryngeal nerve block
- 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.
Steroid/Anesthesia MixtureDrug
Steroid will be Triamcinolone Acetonide (40mg/mL). Anesthetic will be 0.5% bupivacaine with 1:100,000 epinephrine. These will be pre-mixed by a qualified personnel within the ENT department.
PlaceboDrug
2 mL of Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Steroid/Anesthetic Mixture) | Experimental | The steroid/anesthetic mixture will be injected via a 27-gauge needle once at the baseline or during the 6-week crossover timepoint. Receives: Drug: Steroid/Anesthesia Mixture |
| Placebo (Normal Saline) | Placebo comparator | The placebo (Normal Saline) will be injected via a 27-gauge needle once at the baseline or during the 6-week crossover timepoint. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention vs. Placebo in Neurogenic Cough using Capsaicin Challenge
Objectively evaluate the efficacy of blockade of the internal branch of the superior laryngeal nerve with local anesthetic/steroid mixture compared to normal saline placebo in treating chronic neurogenic cough using capsaicin challenge testing to measure cough sensitivity and urge to cough
Measured: Comparing Changes at Pretreatment, at 30 minutes post treatment, at 1 week post treatment, and at 6 weeks post treatment
Secondary outcomes (4)
Intervention vs. Placebo in Neurogenic Cough using the Newcastle Laryngeal Hypersensitivity Questionnaire
Subjectively evaluate the efficacy of superior laryngeal nerve block (intervention) vs. placebo using the Newcastle Laryngeal Hypersensitivity Questionnaire (NLHQ). This Questionnaire is scaled from 1 to 7. 1 indicates All of the Time while 7 reflects None of the Time.
Measured: Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment
Intervention vs. Placebo in Neurogenic Cough using the Urge to Cough Scale
Subjectively evaluate the efficacy of superior laryngeal nerve block (intervention) vs. placebo using the Urge to Cough Scale. Higher score indicates more urge, while lower score reflects less of an urge to cough.
Measured: Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment
Intervention vs. Placebo in Neurogenic Cough using the Central Sensitization Inventory
Subjectively evaluate the efficacy of superior laryngeal nerve block (intervention) vs. placebo using the Central Sensitization Inventory (CSI). Scale is ranked as Never, Rarely, Sometimes, Often, and Always and has various symptoms listed.
Measured: Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment
Quality of Life Measurements
Analyze quality of life measurements of patients undergoing superior laryngeal nerve block compared to placebo as measured by the Leicester Cough Questionnaire (LCQ). Scale is from a 1 to 7. The higher the score/rating represents less of a problem while a lower score/rating represents more of a problem.
Measured: Pretreatment, 1 week post treatment, 6 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start21 Jul 2021
- Primary completion25 Jun 2023 (estimated)
- Study completion25 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal Nerve BlockStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin J Rubinstein, Eastern Virginia Medical School
- Investigators
- Benjamin Rubinstein, MD, Principal investigator, Eastern Virginia Medical School Department of Otolaryngology - Head and Neck Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292677
- Sponsor's protocol ID
- 14Jul2021
- Status last verified
- Mar 2022
- First submitted
- 14 Sep 2021
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-Blind Randomized Trial of in Office Superior Laryngeal Nerve Block for the Treatment of Chronic Neurogenic Cough
- ClinicalTrials.gov ID
- NCT05292677
- Acronym / sponsor ID
- 14Jul2021
- Keywords
- cough, chronic cough, neurogenic cough, laryngeal nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 25 Jun 2023 (estimated)
- Study completion
- 25 Jun 2023 (estimated)
- First posted
- 23 Mar 2022 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (Steroid/Anesthetic Mixture) | Experimental | Drug: Steroid/Anesthesia MixtureThe steroid/anesthetic mixture will be injected via a 27-gauge needle once at the baseline or during the 6-week crossover timepoint. |
| Placebo (Normal Saline) | Placebo comparator | Drug: PlaceboThe placebo (Normal Saline) will be injected via a 27-gauge needle once at the baseline or during the 6-week crossover timepoint. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years and older
- Previously or Newly Diagnosed Chronic Neurogenic Cough
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Steroid/Anesthesia MixtureSteroid will be Triamcinolone Acetonide (40mg/mL). Anesthetic will be 0.5% bupivacaine with 1:100,000 epinephrine. These will be pre-mixed by a qualified personnel within the ENT department. | Drug | Intervention (Steroid/Anesthetic Mixture) |
| Placebo2 mL of Normal Saline | Drug | Placebo (Normal Saline) |
Primary outcome
Intervention vs. Placebo in Neurogenic Cough using Capsaicin Challenge
Time frame: Comparing Changes at Pretreatment, at 30 minutes post treatment, at 1 week post treatment, and at 6 weeks post treatment
Objectively evaluate the efficacy of blockade of the internal branch of the superior laryngeal nerve with local anesthetic/steroid mixture compared to normal saline placebo in treating chronic neurogenic cough using capsaicin challenge testing to measure cough sensitivity and urge to cough
4 secondary outcomes
Intervention vs. Placebo in Neurogenic Cough using the Newcastle Laryngeal Hypersensitivity Questionnaire
Time frame: Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment
Intervention vs. Placebo in Neurogenic Cough using the Urge to Cough Scale
Time frame: Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment
Intervention vs. Placebo in Neurogenic Cough using the Central Sensitization Inventory
Time frame: Pretreatment, 30 minutes post treatment, 1 week post treatment, 6 weeks post treatment
Quality of Life Measurements
Time frame: Pretreatment, 1 week post treatment, 6 weeks post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
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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.
Benjamin Rubinstein, MD principal investigator
Eastern Virginia Medical School Department of Otolaryngology - Head and Neck Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Steroid/Anesthesia Mixture in people with Laryngeal Nerve Block and Chronic Neurogenic Cough, run by Eastern Virginia Medical School 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 2 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: status not confirmed, as of the sponsor's last update on 23 Mar 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Addy Tham, MS (757.388.6264, thama@evms.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention vs. Placebo in Neurogenic Cough using Capsaicin Challenge (time frame: Comparing Changes at Pretreatment, at 30 minutes post treatment, at 1 week post treatment, and at 6 weeks post treatment). 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 Mar 2022.