Trial Outcomes & Findings for Efficacy of SLN Block for Chronic Cough (NCT NCT04421092)
NCT ID: NCT04421092
Last Updated: 2025-10-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
17 participants
Primary outcome timeframe
Change from Baseline to 3 months
Results posted on
2025-10-23
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
10
|
|
Overall Study
COMPLETED
|
7
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of SLN Block for Chronic Cough
Baseline characteristics by cohort
| Measure |
Steroid-Lidocaine Mixture
n=10 Participants
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.
|
Placebo
n=7 Participants
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.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
56.3 years
n=5 Participants
|
56.3 years
n=7 Participants
|
56.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to 3 monthsPatient 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.
Outcome measures
| Measure |
Steroid-Lidocaine Mixture
n=10 Participants
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.
|
Placebo
n=7 Participants
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.
|
|---|---|---|
|
Change in Cough Severity
|
13.15 LCQ scores (baseline to 3 months)
Standard Deviation 4.52
|
9.54 LCQ scores (baseline to 3 months)
Standard Deviation 3.87
|
SECONDARY outcome
Timeframe: Baseline, 1-4 weeks post-injection, and 3 months post-treatmentImprovement 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.
Outcome measures
| Measure |
Steroid-Lidocaine Mixture
n=10 Participants
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.
|
Placebo
n=7 Participants
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.
|
|---|---|---|
|
Subjective Improvement in Cough
|
10 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Daily for 3 months post-injectionParticipants 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.
Outcome measures
| Measure |
Steroid-Lidocaine Mixture
n=10 Participants
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.
|
Placebo
n=7 Participants
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.
|
|---|---|---|
|
Summed Daily Change in Subjective Cough Severity
|
13.15 score on a scale
Standard Deviation 4.52
|
9.54 score on a scale
Standard Deviation 3.87
|
Adverse Events
Steroid-Lidocaine Mixture
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Steroid-Lidocaine Mixture
n=10 participants at risk
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.
|
Placebo
n=7 participants at risk
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.
|
|---|---|---|
|
Investigations
Mild transient soreness at injection site
|
30.0%
3/10 • Number of events 3 • 1 year and 6 months
This is a routine procedure done by laryngologists.
|
14.3%
1/7 • Number of events 1 • 1 year and 6 months
This is a routine procedure done by laryngologists.
|
Additional Information
Shaun A. Nguyen, MD - Director of Clinical Research
Medical University of South Carolina - Department of Otolaryngology
Phone: 8437921356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place