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

Laryngopharyngeal Reflux Clinical Trial

— PHARO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01854970
• Other study ID #: CHUBX 2012/08
• Status: Completed
• Phase: N/A
• First received: May 3, 2013
• Last updated: July 22, 2015
• Start date: May 2013
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laryngopharyngeal Reflux
• Oesophageal pH-impedance

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of pharyngeal reflux/24h		visit 3 - 60 days after inclusion	No
Primary	• Number of pharyngeal acid reflux/24h		Visit 3 - 60 days after inclusion	No
Primary	• Number of pharyngeal less acid reflux/24h		Visit 3 - 60 days after inclusion	No
Primary	• Pharyngeal acid exposure (% of total time with pharyngeal pH <4)		Visit 3 - 60 days after inclusion	No
Primary	• Pharyngeal bolus exposure (% of total time with liquid in the pharynx)		Visit 3 - 60 days after inclusion	No