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NCT Number: NCT01854970

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

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.

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Key information

Conditions

Laryngopharyngeal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Laryngeal Diseases Oesophageal pH-impedance Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux

Bordeaux, 33000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esomeprazole

Drug

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.

Primary outcomes

  1. Number of pharyngeal reflux/24h

    Time frame: visit 3 - 60 days after inclusion

  2. • Number of pharyngeal acid reflux/24h

    Time frame: Visit 3 - 60 days after inclusion

  3. • Number of pharyngeal less acid reflux/24h

    Time frame: Visit 3 - 60 days after inclusion

  4. • Pharyngeal acid exposure (% of total time with pharyngeal pH <4)

    Time frame: Visit 3 - 60 days after inclusion

  5. • Pharyngeal bolus exposure (% of total time with liquid in the pharynx)

    Time frame: Visit 3 - 60 days after inclusion

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: PHARO

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 16, 2013
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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