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

May 11, 2026 updated by: University Hospital, Bordeaux

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

Intervention / Treatment

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 (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimated)

May 16, 2013

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2012/08
  • 2012-004528-39 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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