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

NCT01854970 | Completed

• 1 other identifier: CHUBX 2012/08
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laryngopharyngeal Reflux; Oesophageal pH-impedance

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Patient

EXPERIMENTAL

Drug: esomeprazole

Interventions

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.

Patient

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Laryngopharyngeal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: May 16, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 23, 2015

Record last verified: 2015-07

Locations

FR (1)