Cough, Neurogenic Cough, Superior Laryngeal Nerve Block
Conditions
Keywords
superior laryngeal nerve block, chronic cough
Brief 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, 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.
Interventions
PROCEDURESuperior 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.
PROCEDUREInjection of placebo (saline)
Superior laryngeal nerve block using 1mL of saline as the injection.
PROCEDUREInjection of steroid-lidocaine mixture
Superior laryngeal nerve block using 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* History consistent with neurogenic cough * Exclusion of other etiologies (see
Exclusion criteria
) * Age ≥ 18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cough Severity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Improvement in Cough | Baseline, 1-4 weeks post-injection, and 3 months post-treatment | 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. |
| Summed Daily Change in Subjective Cough Severity | Daily for 3 months post-injection | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 7 |
| Total | 17 |
Baseline characteristics
| Characteristic | Total | Steroid-Lidocaine Mixture | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 10 Participants | 7 Participants |
| Age, Continuous | 56.3 years | 56.3 years | 56.3 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 8 Participants | 7 Participants |
| Region of Enrollment United States | 17 Participants | 10 Participants | 7 Participants |
| Sex: Female, Male Female | 15 Participants | 9 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 7 |
| other Total, other adverse events | 3 / 10 | 1 / 7 |
| serious Total, serious adverse events | 0 / 10 | 0 / 7 |
Outcome results
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.
Time frame: Change from Baseline to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid-Lidocaine Mixture | Change in Cough Severity | 13.15 LCQ scores (baseline to 3 months) | Standard Deviation 4.52 |
| Placebo | Change in Cough Severity | 9.54 LCQ scores (baseline to 3 months) | Standard Deviation 3.87 |
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.
Time frame: Baseline, 1-4 weeks post-injection, and 3 months post-treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Steroid-Lidocaine Mixture | Subjective Improvement in Cough | 10 participants |
| Placebo | Subjective Improvement in Cough | 7 participants |
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.
Time frame: Daily for 3 months post-injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Steroid-Lidocaine Mixture | Summed Daily Change in Subjective Cough Severity | 13.15 score on a scale | Standard Deviation 4.52 |
| Placebo | Summed Daily Change in Subjective Cough Severity | 9.54 score on a scale | Standard Deviation 3.87 |