Status:
COMPLETED
Study of an Oropharyngeal Aerosolized pH Probe for Diagnosing Laryngopharyngeal Reflux (LPR)
Lead Sponsor:
Emory University
Collaborating Sponsors:
AstraZeneca
Respiratory Technology Corporation
Conditions:
Laryngopharyngeal Reflux
Eligibility:
All Genders
18+ years
Brief Summary
This study is a test of how well a new FDA-approved device is for diagnosing a condition known as laryngopharyngeal reflux (LPR). The device, which measures pH of the air in the upper throat, will be ...
Detailed Description
It is estimated that up to 50% of patients with voice disorders and 4-10% of patients seen in otolaryngology practice experience laryngopharyngeal reflux (LPR). LPR has been implicated in the pathogen...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Group 1 (negative control):
- RSI ≤ 13
- No history of voice or swallowing disorders
- No active voice or swallowing disorders
- No history of heartburn, regular indigestion, and no prior or current diagnosis of GERD
- Groups 2 and 3 (experimental group):
- Clinical symptoms consistent with LPR as measured by an RSI \> 13.
- No other voice or swallowing pathology on clinical exam
- EXCLUSION CRITERIA:
- Regular treatment with an H2 blocker or proton pump inhibitor (PPI)
- History of laryngeal/pharyngeal surgery
- Any planned treatment of the larynx/pharynx other than treatment for LPR
- Smoking
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00321503
Start Date
May 1 2006
End Date
May 1 2007
Last Update
December 9 2013
Active Locations (1)
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1
Emory Voice Center
Atlanta, Georgia, United States, 30309