Efficacy of Reza Band for the Treatment of Laryngopharyngeal Reflux
NCT ID: NCT03463395
Last Updated: 2020-05-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Clinical Phase
NA
Study Classification
INTERVENTIONAL
Study Start Date
2020-07-31
Study Completion Date
2021-11-30
Brief Summary
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We hypothesize that tissue and salivary pepsin will resolve after 12 weeks use of Reza Band, but not following standard of care alone. Additionally, RFS, RSI and inflammatory cytokines (IL -1β, -6, and -8) will decrease to normative levels following 12 weeks use of Reza Band, but not with standard of care alone.
Primary Objective The primary objective is to evaluate the efficacy of the Reza Band for the treatment of LPR. We propose a pilot clinical trial to test the hypothesis that the Reza Band is effective for the treatment of LPR, measured by resolution of pepsin and decrease to normative values for RSI, Reflux Finding Score (RFS) and inflammatory cytokines.
The long-term goal is to determine the efficacy of the Reza Band in the sequential progression of reflux-attributed laryngeal inflammatory and neoplastic disease.
Primary Objective The primary objective is to evaluate the efficacy of the Reza Band for the treatment of LPR. We propose a pilot clinical trial to test the hypothesis that the Reza Band is effective for the treatment of LPR, measured by resolution of pepsin and decrease to normative values for RSI, Reflux Finding Score (RFS) and inflammatory cytokines.
The long-term goal is to determine the efficacy of the Reza Band in the sequential progression of reflux-attributed laryngeal inflammatory and neoplastic disease.
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Detailed Description
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We propose a prospective cohort study. Sixty patients ≥ 18 years of age presenting to our laryngology outpatient clinic with LPR, with an RFS ≥ 7 and an RSI ≥ 13, not on anticoagulants, able to tolerate an endoscopy and consent to participate in this research study will be included. The study will consist of two cohorts. Cohort one will receive standard care (n = 30), and cohort two will receive standard care plus the Reza Band (to be worn as recommended by the manufacturer; n = 30). Patients will be assigned to either of the cohorts, based on their preferences.
Two laryngeal (posterior cricoid) biopsy specimens (one for pepsin ELISA and the other for qPCR for IL -1β, -6, and -8 inflammatory cytokines) and a throat saliva sample (for pepsin ELISA) will be obtained pre- and posttreatment (12 weeks) in an ambulatory clinic setting. The RSI, a patient-reported symptom severity questionnaire, will be administered in the clinic pre- and posttreatment. (36) Patients will be instructed to cough and clear the back of their throat to provide a saliva sample prior to endoscopy. The RFS (37) will be obtained by the study physicians during office endoscopy prior to biopsy. Deidentified biopsy and saliva samples will be transported to the research laboratory on ice and stored at -80 prior to analyses by ELISA and qPCR.
Pepsin ELISA One biopsy per subject will be homogenized in urea lysis buffer and total protein concentration determined as previously described (28). Saliva samples will be cleared by brief centrifugation. Noncompetitive indirect sandwich enzyme-linked immunosorbent assay described previously (35) will be performed to detect pepsin in biopsy homogenate and saliva.
qPCR RNA will be extracted from a second biopsy, DNAsed and reverse transcribed as described (38). Real time polymerase chain reaction will be performed in a Viaa7 Real Time PCR System using Taqman Gene Expression Assays targeting IL -1β, -6, and -8, and the housekeeping gene HPRT1 (ThermoFisher Scientific, Waltham, MA).
This pilot study will pave the way for clinical trials of a much-needed therapy for airway reflux. If the hypothesis proves true and the Reza Band resolves pepsin and inflammatory cytokines, and significantly improves endoscopic signs (RFS) and symptoms (RSI) of LPR, these data will also support a clinical trial to assess the utility of the Reza Band in preventing reflux-attributed laryngeal inflammatory and neoplastic disease sequelae. To our knowledge, this is the first study that will use pepsin as a primary outcome measure; it is believed to be a sensitive and specific biomarker for reflux and aspiration.
Deidentified biopsy and saliva samples will be transported to the research laboratory on ice and stored at -80 degrees C prior to analyses by ELISA and qPCR. The tissue and saliva samples will be labeled with patient study ID number and date of collection.
Two laryngeal (posterior cricoid) biopsy specimens (one for pepsin ELISA and the other for qPCR for IL -1β, -6, and -8 inflammatory cytokines) and a throat saliva sample (for pepsin ELISA) will be obtained pre- and posttreatment (12 weeks) in an ambulatory clinic setting. The RSI, a patient-reported symptom severity questionnaire, will be administered in the clinic pre- and posttreatment. (36) Patients will be instructed to cough and clear the back of their throat to provide a saliva sample prior to endoscopy. The RFS (37) will be obtained by the study physicians during office endoscopy prior to biopsy. Deidentified biopsy and saliva samples will be transported to the research laboratory on ice and stored at -80 prior to analyses by ELISA and qPCR.
Pepsin ELISA One biopsy per subject will be homogenized in urea lysis buffer and total protein concentration determined as previously described (28). Saliva samples will be cleared by brief centrifugation. Noncompetitive indirect sandwich enzyme-linked immunosorbent assay described previously (35) will be performed to detect pepsin in biopsy homogenate and saliva.
qPCR RNA will be extracted from a second biopsy, DNAsed and reverse transcribed as described (38). Real time polymerase chain reaction will be performed in a Viaa7 Real Time PCR System using Taqman Gene Expression Assays targeting IL -1β, -6, and -8, and the housekeeping gene HPRT1 (ThermoFisher Scientific, Waltham, MA).
This pilot study will pave the way for clinical trials of a much-needed therapy for airway reflux. If the hypothesis proves true and the Reza Band resolves pepsin and inflammatory cytokines, and significantly improves endoscopic signs (RFS) and symptoms (RSI) of LPR, these data will also support a clinical trial to assess the utility of the Reza Band in preventing reflux-attributed laryngeal inflammatory and neoplastic disease sequelae. To our knowledge, this is the first study that will use pepsin as a primary outcome measure; it is believed to be a sensitive and specific biomarker for reflux and aspiration.
Deidentified biopsy and saliva samples will be transported to the research laboratory on ice and stored at -80 degrees C prior to analyses by ELISA and qPCR. The tissue and saliva samples will be labeled with patient study ID number and date of collection.
Conditions
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Laryngopharyngeal Reflux
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Sixty patients ≥ 18 years of age presenting to the investigator's laryngology outpatient clinic with LPR, with an RFS ≥ 7 and an RSI ≥ 13, not on anticoagulants, able to tolerate an endoscopy and consent to participate in this research study will be included. One cohort (Group A) will receive standard care (n =30), the other (Group B) will receive standard care plus the Reza band (to be worn as recommended by the manufacturer; n = 30).
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Standard of Care
Group A will receive standard of care
Group Type
NO_INTERVENTION
No interventions assigned to this group
Reza band use
Group B will receive standard care plus the Reza band (worn as recommended by the manufacturer)
Group Type
EXPERIMENTAL
Reza band
Intervention Type
DEVICE
Reza band, a non-medication, non-surgical medical device designed to reduce symptoms of LPR has recently been approved by the FDA. It works by stopping the flow of gastric contents through the upper esophageal sphincter (UES) by increasing the internal pressure of the UES
Interventions
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Reza band
Reza band, a non-medication, non-surgical medical device designed to reduce symptoms of LPR has recently been approved by the FDA. It works by stopping the flow of gastric contents through the upper esophageal sphincter (UES) by increasing the internal pressure of the UES
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
1. Clinical diagnosis of laryngopharyngeal reflux (LPR).
2. Age ≥ 18 years.
3. Reflux Finding Score (RFS) of ≥ 7 and an Reflux Symptom Index (RSI) ≥ 13.
4. Patients should be able to tolerate an endoscopy.
5. Patients must be deemed able to comply with the treatment plan and follow-up schedule.
6. Enrollment on an interventional postoperative study is allowed if study device/agents do not overlap i.e. no other investigational device or medication for the treatment of LPR is permitted during the duration of this study.
7. Patients must provide study-specific informed consent prior to study entry.
2. Age ≥ 18 years.
3. Reflux Finding Score (RFS) of ≥ 7 and an Reflux Symptom Index (RSI) ≥ 13.
4. Patients should be able to tolerate an endoscopy.
5. Patients must be deemed able to comply with the treatment plan and follow-up schedule.
6. Enrollment on an interventional postoperative study is allowed if study device/agents do not overlap i.e. no other investigational device or medication for the treatment of LPR is permitted during the duration of this study.
7. Patients must provide study-specific informed consent prior to study entry.
Exclusion Criteria
1. Patient should not be on anticoagulants
2. Currently being treated with another investigational medical device and/or drug.
3. Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP).
4. The patient is female and is of childbearing potential and is not using an acceptable method of birth control or is pregnant or breast-feeding.
5. Previous head or neck surgery or radiation.
6. Carotid artery disease, thyroid disease or history of cerebral vascular disease.
7. Suspected esophageal cancer.
8. Has either a pacemaker or implanted cardioverter defibrillator (ICD).
9. Nasopharyngeal cancer.
10. Previously undergone Nissen Fundoplication.
2. Currently being treated with another investigational medical device and/or drug.
3. Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP).
4. The patient is female and is of childbearing potential and is not using an acceptable method of birth control or is pregnant or breast-feeding.
5. Previous head or neck surgery or radiation.
6. Carotid artery disease, thyroid disease or history of cerebral vascular disease.
7. Suspected esophageal cancer.
8. Has either a pacemaker or implanted cardioverter defibrillator (ICD).
9. Nasopharyngeal cancer.
10. Previously undergone Nissen Fundoplication.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Medical College of Wisconsin
OTHER
Sponsor Role
lead
Responsible Party
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John Rhee
Professor and Chairman
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Nikki Johnston, PhD
Role: STUDY_DIRECTOR
Medical College of Wisconsin
Locations
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Froedtert Hospital and Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Site Status
Countries
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United States
References
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Ford CN. Evaluation and management of laryngopharyngeal reflux. JAMA. 2005 Sep 28;294(12):1534-40. doi: 10.1001/jama.294.12.1534.
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Szczesniak MM, Williams RB, Brake HM, Maclean JC, Cole IE, Cook IJ. Upregulation of the esophago-UES relaxation response: a possible pathophysiological mechanism in suspected reflux laryngitis. Neurogastroenterol Motil. 2010 Apr;22(4):381-6, e89. doi: 10.1111/j.1365-2982.2009.01452.x.
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Johnston N, Dettmar PW, Lively MO, Postma GN, Belafsky PC, Birchall M, Koufman JA. Effect of pepsin on laryngeal stress protein (Sep70, Sep53, and Hsp70) response: role in laryngopharyngeal reflux disease. Ann Otol Rhinol Laryngol. 2006 Jan;115(1):47-58. doi: 10.1177/000348940611500108.
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Johnston N, Knight J, Dettmar PW, Lively MO, Koufman J. Pepsin and carbonic anhydrase isoenzyme III as diagnostic markers for laryngopharyngeal reflux disease. Laryngoscope. 2004 Dec;114(12):2129-34. doi: 10.1097/01.mlg.0000149445.07146.03.
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BACKGROUND
Wassenaar E, Johnston N, Merati A, Montenovo M, Petersen R, Tatum R, Pellegrini C, Oelschlager B. Pepsin detection in patients with laryngopharyngeal reflux before and after fundoplication. Surg Endosc. 2011 Dec;25(12):3870-6. doi: 10.1007/s00464-011-1813-z. Epub 2011 Jun 22.
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Hayat JO, Gabieta-Somnez S, Yazaki E, Kang JY, Woodcock A, Dettmar P, Mabary J, Knowles CH, Sifrim D. Pepsin in saliva for the diagnosis of gastro-oesophageal reflux disease. Gut. 2015 Mar;64(3):373-80. doi: 10.1136/gutjnl-2014-307049. Epub 2014 May 7.
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BACKGROUND
Crapko M, Kerschner JE, Syring M, Johnston N. Role of extra-esophageal reflux in chronic otitis media with effusion. Laryngoscope. 2007 Aug;117(8):1419-23. doi: 10.1097/MLG.0b013e318064f177.
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Knight J, Lively MO, Johnston N, Dettmar PW, Koufman JA. Sensitive pepsin immunoassay for detection of laryngopharyngeal reflux. Laryngoscope. 2005 Aug;115(8):1473-8. doi: 10.1097/01.mlg.0000172043.51871.d9.
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Luebke K, Samuels TL, Chelius TH, Sulman CG, McCormick ME, Kerschner JE, Johnston N, Chun RH. Pepsin as a biomarker for laryngopharyngeal reflux in children with laryngomalacia. Laryngoscope. 2017 Oct;127(10):2413-2417. doi: 10.1002/lary.26537. Epub 2017 Feb 22.
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BACKGROUND
Belafsky PC, Postma GN, Koufman JA. Validity and reliability of the reflux symptom index (RSI). J Voice. 2002 Jun;16(2):274-7. doi: 10.1016/s0892-1997(02)00097-8.
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Belafsky PC, Postma GN, Koufman JA. The validity and reliability of the reflux finding score (RFS). Laryngoscope. 2001 Aug;111(8):1313-7. doi: 10.1097/00005537-200108000-00001.
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Samuels TL, Handler E, Syring ML, Pajewski NM, Blumin JH, Kerschner JE, Johnston N. Mucin gene expression in human laryngeal epithelia: effect of laryngopharyngeal reflux. Ann Otol Rhinol Laryngol. 2008 Sep;117(9):688-95. doi: 10.1177/000348940811700911.
Reference Type
BACKGROUND
Other Identifiers
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PRO30948
Identifier Type: -
Identifier Source: org_study_id
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