Status:
UNKNOWN
Randomized Placebo-controlled Analysis of Superior Laryngeal Nerve Block for Neurogenic Cough
Lead Sponsor:
University of South Florida
Conditions:
Cough
Nerve Block
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 improveme...
Detailed Description
Abbreviations/ Definitions: cough severity index (CSI), Cough quality of life questionnaire (CQLQ), proton pump inhibitor (PPI), nasopharyngolaryngoscopy (NPL), University of South Florida (USF), supe...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
January 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04468542
Start Date
January 12 2021
End Date
December 1 2022
Last Update
November 8 2022
Active Locations (1)
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1
University of South Florida South Tampa Clinic
Tampa, Florida, United States, 33612