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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steroid-Lidocaine Mixture | Experimental | Will receive numbing injection, which is a mixture of steroid and lidocaine |
|
| Placebo | Placebo Comparator | Will receive saline injection as a placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Superior laryngeal nerve block | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1-4 weeks post-injection, and 3 months post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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)
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| Name | Affiliation | Role |
|---|---|---|
| Courtney Tipton | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29403 | United States |
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Subjects will be recruited within the standard workup for chronic cough in the clinic. Patients will be screened at the initial visit if they meet inclusion criteria or at further visits after additional workup for other sources of cough is completed, patients will be offered participation in the study. The principal investigator will discuss risks and benefits of study participation with the eligible subjects using the informed consent form.
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| ID | Title | Description |
|---|---|---|
| FG000 | Steroid-Lidocaine Mixture | Will receive numbing injection, which is a mixture of steroid and lidocaine Superior laryngeal nerve block: 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 steroid-lidocaine mixture: Superior laryngeal nerve block using 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection. |
| FG001 | Placebo | Will receive saline injection as a placebo Superior laryngeal nerve block: 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): Superior laryngeal nerve block using 1mL of saline as the injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
LCQ scores, VAS scores
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| ID | Title | Description |
|---|---|---|
| BG000 | Steroid-Lidocaine Mixture | Will receive numbing injection, which is a mixture of steroid and lidocaine Superior laryngeal nerve block: 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 steroid-lidocaine mixture: Superior laryngeal nerve block using 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | LCQ scores (baseline to 3 months) | Change from Baseline to 3 months |
|
1 year and 6 months
This is a routine procedure done by laryngologists.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Steroid-Lidocaine Mixture | Will receive numbing injection, which is a mixture of steroid and lidocaine Superior laryngeal nerve block: 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 steroid-lidocaine mixture: Superior laryngeal nerve block using 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild transient soreness at injection site | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shaun A. Nguyen, MD - Director of Clinical Research | Medical University of South Carolina - Department of Otolaryngology | 8437921356 | nguyensh@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2022 | Dec 26, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003371 | Cough |
| D000096822 | Chronic Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D014221 | Triamcinolone |
| D008012 | Lidocaine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Two treatment arms:
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|
| Injection of placebo (saline) | Procedure | Superior laryngeal nerve block using 1mL of saline as the injection. |
|
|
| Injection of steroid-lidocaine mixture | Procedure | Superior laryngeal nerve block using 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection. |
|
|
| 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. |
| Daily for 3 months post-injection |
| BG001 | Placebo | Will receive saline injection as a placebo Superior laryngeal nerve block: 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): Superior laryngeal nerve block using 1mL of saline as the injection. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Placebo | Will receive saline injection as a placebo Superior laryngeal nerve block: 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): Superior laryngeal nerve block using 1mL of saline as the injection. |
|
|
| Secondary | 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. | Posted | Number | participants | Baseline, 1-4 weeks post-injection, and 3 months post-treatment |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Daily for 3 months post-injection |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 3 |
| 10 |
| EG001 | Placebo | Will receive saline injection as a placebo Superior laryngeal nerve block: 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): Superior laryngeal nerve block using 1mL of saline as the injection. | 0 | 7 | 0 | 7 | 1 | 7 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |