Benefit of Pharyngeal and Oesophageal pH-impedance of Patients With High Suspicion of Laryngopharyngeal Reflux

Study Overview
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Brief Summary
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Laryngopharyngeal reflux (LPR) is the retrograde movement of gastric contents into the larynx, pharynx and upper aerodigestive tract. The symptoms and manifestations are very changeable and non specific. Pharyngeal and Oesophageal pH-impedance may help to detect these reflux and to identify patients with abnormal LPR. To compare and describe the results of pharyngeal and oesophageal pH-impedance of patients with high suspicion of laryngopharyngeal reflux, with the results of healthy patients.

Detailed Description
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This is a monocentric, prospective descriptive study. Patients will be recruited in otolaryngology and gastroenterology departments of Bordeaux teaching hospital. A first clinical, endoscopic and pH-impedance evaluation will be made, after at least 15 days of interruption of any proton pump inhibitors (PPI). After 8 weeks' treatment by double PPI doses (esomeprazole 40 mg bid), another clinical and pH-impedance evaluation will be realized. The characteristics of the patients who respond to the treatment will be compared to non responders. The subjects will also have an initial laryngoscopy, an oesophageal manometry allowing the location of the lower sphincter of the oesophagus and the upper sphincter of the oesophagus for positioning the catheters.

Official Title
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Benefit of Pharyngeal and Oesophageal pH-impedance of Patients With High Suspicion of Laryngopharyngeal Reflux

Conditions
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Laryngopharyngeal Reflux, Oesophageal pH-impedance

Intervention / Treatment
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* Drug: esomeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age : 18 to 80 years old. Written consent Laryngopharyngeal symptoms (dysphonia, and/or globus and/or sensation, and/or pharyngeal pain, and/or cough) for 3 months at least. No PPI for at least 15 days Social security affiliation Exclusion Criteria: Sinusitis or chronic rhinitis (in the previous year) Laryngeal trauma, tracheotomy or pharyngolaryngeal surgery pregnancy or absence of efficacy contraception breast feeding history of gastrointestinal pathology, diabetes, neurological condition cardio-vascular history requiring the taking of Plavix esomeprazole contraindication or intolerance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient<br> | Drug: esomeprazole<br>* Patients with pharyngolaryngeal symptoms will have a clinical evaluation, laryngoscopy, and pharyngoesophageal pH-impedance. Then a treatment by esomeprazole during 8 weeks in the term of which the second clinical evaluation and pH-impedance will be made.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of pharyngeal reflux/24h |  | visit 3 - 60 days after inclusion | 
| • Number of pharyngeal acid reflux/24h |  | Visit 3 - 60 days after inclusion | 
| • Number of pharyngeal less acid reflux/24h |  | Visit 3 - 60 days after inclusion | 
| • Pharyngeal acid exposure (% of total time with pharyngeal pH <4) |  | Visit 3 - 60 days after inclusion | 
| • Pharyngeal bolus exposure (% of total time with liquid in the pharynx) |  | Visit 3 - 60 days after inclusion |