Randomized Placebo-controlled Analysis of Superior Laryngeal Nerve Block for Neurogenic Cough

NCT04468542 | Unknown Phase 3 FDA Drug

• 1 other identifier: STUDY001182
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cough; Nerve Block

Keywords

Superior laryngeal nerve; Neurogenic cough; Nerve Block; Idiopathic cough

Outcome Measures

Primary Outcomes (2)

• 2 week post-treatment cough severity index score improvement

  Measure of efficacy of intervention by comparing change in pre-treatment and 2 week post-treatment cough severity index scores between intervention to placebo

  Immediately pre-treatment and post-treatment at 2 weeks

• 2 week post-treatment cough-specific quality-of-life questionnaire score improvement

  Measure of efficacy of intervention by comparing change in pre-treatment and 2 week post-treatment cough-specific quality-of-life questionnaire scores between intervention to placebo

  Immediately pre-treatment and post-treatment at 2 weeks

Secondary Outcomes (4)

• 6 week post-treatment cough severity index score improvement

  Immediately pre-treatment and post-treatment at 6 weeks

• 12 week post-treatment cough severity index score improvement

  Immediately pre-treatment and post-treatment at 12 weeks

• 6 week post-treatment cough-specific quality-of-life questionnaire score improvement

  Immediately pre-treatment and post-treatment at 6 weeks

• 12 week post-treatment cough-specific quality-of-life questionnaire score improvement

  Immediately pre-treatment and post-treatment at 12 weeks

Study Arms (2)

Bupivacaine/triamcinolone injection

EXPERIMENTAL

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

Drug: Superior laryngeal nerve block - Intervention (Bupivacaine and triamcinolone acetonide suspension)

Saline injection

PLACEBO COMPARATOR

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

Drug: Superior laryngeal nerve block - Placebo (saline)

Interventions

Superior laryngeal nerve block - Intervention (Bupivacaine and triamcinolone acetonide suspension) DRUG

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

Bupivacaine/triamcinolone injection

Superior laryngeal nerve block - Placebo (saline) DRUG

2-cc injection of 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

Saline injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking adults referred into or treated by the University of South Florida department of Otolaryngology practice with chronic cough (including throat clearing with globus) as determined by presence \> 8 weeks duration
• Presumed to have neurogenic component based on history with no other obvious treatable (and untreated) cause
• refractory to proton pump inhibitor (PPI) therapy (at least 4 week trial)
• no improvement of upper airway cough syndrome symptoms with medications if indicated (eg, Flonase and antihistamine)
• Patients may continue any medications for possibly related conditions (e.g., Flonase, gabapentin, etc.) including allergies, chronic sinusitis, acid reflux; there should be NO changes to mediation regimen within 1 months of study initiation (with the exception of patients who were not previously on PPI that failed trail of PPI which they will discontinue 1 month prior to first intervention)
• Willingness to participant be assigned and adhere to the protocol. Participants must be willing and able to consent to participate in the study, be willing to undergo intervention or the placebo, and be willing to commit to adhere to the study protocol for the duration of the trial (PPI trial if applicable, 2-4 visits, follow up questionnaires, participate in cough suppression)

You may not qualify if:

• unwilling to participate in protocol
• allergic to Marcaine/lidocaine or predisposing condition to allergy
• uncontrolled medical condition (this will be treated on a case by case basis using clinical judgment of risks and the medical condition, with participants being excluded who have conditions that may significantly increase the odds of having a serious or life-threatening reaction)
• pulmonary processes (including chronic obstructive pulmonary disease (chronic obstructive pulmonary disease), bronchiectasis, non-asthmatic eosinophilic bronchitis, structural abnormalities, etc.)
• asthma (must have history of abnormal pulmonary function provocation testing)
• structural abnormality laryngoscopy (this does not pertain to inflammatory findings)
• immunocompromised
• current smoker (\>1 cigarette in past month)
• use of angiotensin converting enzyme inhibitor current or within past month
• Vulnerable population: students, employees, socially or economically disadvantaged, wards of the state, pregnant women, cognitively impaired adults, non-adults.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida South Tampa Clinic

Tampa, Florida, 33612, United States

RECRUITING

Related Publications (2)

• Simpson CB, Tibbetts KM, Loochtan MJ, Dominguez LM. Treatment of chronic neurogenic cough with in-office superior laryngeal nerve block. Laryngoscope. 2018 Aug;128(8):1898-1903. doi: 10.1002/lary.27201. Epub 2018 Apr 18.

  PMID: 29668037 BACKGROUND

• Dhillon VK. Superior laryngeal nerve block for neurogenic cough: A case series. Laryngoscope Investig Otolaryngol. 2019 Jul 5;4(4):410-413. doi: 10.1002/lio2.292. eCollection 2019 Aug.

  PMID: 31453350 BACKGROUND

MeSH Terms

Conditions

Cough

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Anthony J Grady, MD

CONTACT

(813) 974-5638; agrady@usf.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator (physician)

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 13, 2020
• Study Start: January 12, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)