Bupivacaine/triamcinolone injection for Psychogenic Cough

Phase 3

Recruiting

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

Psychogenic Cough
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

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately pre-treatment and post-treatment at 2 weeks for reporting.

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 more

Awards & 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

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