Benefit of Pharyngeal and Oesophageal pH-impedance of Patients With High Suspicion of Laryngopharyngeal Reflux (PHARO)
Primary Purpose
Laryngopharyngeal Reflux, Oesophageal pH-impedance
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
esomeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Laryngopharyngeal Reflux
Eligibility Criteria
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
Sites / Locations
- CHU de Bordeaux
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient
Arm Description
Outcomes
Primary Outcome Measures
Number of pharyngeal reflux/24h
• Number of pharyngeal acid reflux/24h
• Number of pharyngeal less acid reflux/24h
• Pharyngeal acid exposure (% of total time with pharyngeal pH <4)
• Pharyngeal bolus exposure (% of total time with liquid in the pharynx)
Secondary Outcome Measures
Full Information
NCT ID
NCT01854970
First Posted
May 3, 2013
Last Updated
July 22, 2015
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT01854970
Brief Title
Benefit of Pharyngeal and Oesophageal pH-impedance of Patients With High Suspicion of Laryngopharyngeal Reflux
Acronym
PHARO
Official Title
Benefit of Pharyngeal and Oesophageal pH-impedance of Patients With High Suspicion of Laryngopharyngeal Reflux
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngopharyngeal Reflux, Oesophageal pH-impedance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
esomeprazole
Intervention Description
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 Outcome Measure Information:
Title
Number of pharyngeal reflux/24h
Time Frame
visit 3 - 60 days after inclusion
Title
• Number of pharyngeal acid reflux/24h
Time Frame
Visit 3 - 60 days after inclusion
Title
• Number of pharyngeal less acid reflux/24h
Time Frame
Visit 3 - 60 days after inclusion
Title
• Pharyngeal acid exposure (% of total time with pharyngeal pH <4)
Time Frame
Visit 3 - 60 days after inclusion
Title
• Pharyngeal bolus exposure (% of total time with liquid in the pharynx)
Time Frame
Visit 3 - 60 days after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Benefit of Pharyngeal and Oesophageal pH-impedance of Patients With High Suspicion of Laryngopharyngeal Reflux
We'll reach out to this number within 24 hrs