Clinical trial NCT03463395: Efficacy of Reza Band for the Treatment of Laryngopharyngeal Reflux
Official title: Efficacy of Reza Band for the Treatment of Laryngopharyngeal Reflux
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Laryngopharyngeal Reflux
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Change in Tissue and Salivary Pepsin Levels
timeFrame: The change in Pepsin will be measured pre and post 12 week treatment for LPR +/- Reza band
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital and Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Nikki Johnston, PhD
role: STUDY_DIRECTOR
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