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

Not Applicable

Completed

• Conditions: Laryngopharyngeal Reflux; Oesophageal pH-impedance
• Interventions: Drug: esomeprazole

• Registration Number: NCT01854970
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-03
• Study First Submitted QC: 2013-05-13
• Study First Posted: 2013-05-16
• Status Verified: 2015-07
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Last Update Submitted: 2015-07-22
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient	esomeprazole	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France