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

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.

Study Overview

• Status: Completed
• Conditions: Laryngopharyngeal Reflux; Oesophageal pH-impedance
• Intervention / Treatment: Drug: esomeprazole

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient	Drug: esomeprazole; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: May 3, 2013
• First Submitted That Met QC Criteria: May 13, 2013
• First Posted (Estimate): May 16, 2013

Study Record Updates

• Last Update Posted (Estimate): July 23, 2015
• Last Update Submitted That Met QC Criteria: July 22, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Laryngeal Diseases; Gastroesophageal Reflux; Laryngopharyngeal Reflux; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: CHUBX 2012/08