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Corticosteroid
Randomized Placebo-controlled Analysis of Superior Laryngeal Nerve Block for Neurogenic Cough
Phase 3
Waitlist Available
Research Sponsored by University of South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately pre-treatment and post-treatment at 2 weeks
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Pivotal Trial
Summary
Prospective randomized placebo-controlled trial assessing the efficacy of superior laryngeal nerve block for adults with neurogenic cough refractory to proton pump inhibitor as determined by improvement in validated cough severity questionnaires before and after injection of Marcaine and Kenalog compared to placebo (saline injection).
Eligible Conditions
- Coughing on Induction
- Cough
- Caudal Epidural Block Therapy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately pre-treatment and post-treatment at 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately pre-treatment and post-treatment at 2 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
2 week post-treatment cough severity index score improvement
2 week post-treatment cough-specific quality-of-life questionnaire score improvement
Secondary study objectives
12 week post-treatment cough severity index score improvement
12 week post-treatment cough-specific quality-of-life questionnaire score improvement
6 week post-treatment cough severity index score improvement
+1 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bupivacaine/triamcinolone injectionExperimental Treatment1 Intervention
2-cc injection (mixture consisting of 1-cc of 0.5% Bupivacaine injection and 1cc of 40mg/cc triamcinolone acetonide suspension injection) will be delivered percutaneously into the region of the proximal superior laryngeal nerve, every 1-2 weeks, for total of 2 to 3 injections
Group II: Saline injectionPlacebo Group1 Intervention
2-cc injection of normal saline will be delivered percutaneously into the region of the proximal superior laryngeal nerve, every 1-2 weeks, for total of 2 to 3 injections
Find a Location
Who is running the clinical trial?
University of South FloridaLead Sponsor
426 Previous Clinical Trials
191,774 Total Patients Enrolled