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

University Hospital of Bordeaux

Status: Completed

Conditions: Oesophageal pH-impedance; Laryngopharyngeal Reflux

Treatments: Drug: esomeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01854970

CHUBX 2012/08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Patient

Experimental group

Treatment:

Drug: esomeprazole