An observational study in Laryngopharyngeal Reflux, sponsored by Respiratory Technology Corporation. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-04-11.
Sponsored by Respiratory Technology Corporation · Observational
Acid reflux can cause many symptoms in the throat, including discomfort or pain, and difficulty with breathing and voice problems. Doctors have different ways of diagnosing and treating the reflux that causes these symptoms, and they are trying to better understand what the best ways are to treat the patients with these symptoms.
Usually, a doctor will prescribe medication for reflux based on the symptoms a patient complains of. Sometimes it works and the patient gets better, sometimes it does not work and the patient's condition does not improve. The doctor will also use findings from an examination with an endoscope in the patient's throat to see if there is any damage that might have been caused by reflux. One new device that doctors use to help them diagnose reflux has a sensor on the end of a tube that goes through the nose and rests in the throat. This sensor measures the acid reflux for 24 hours, showing the doctor when acid reflux occurs.
The study doctors are performing this research study to help them understand more about acid reflux disease, and the best ways to diagnose and treat their patients who have acid reflux.
The study involves procedures, medications and devices that are already used regularly in doctors' offices and hospitals. The experimental part of this research is blinding the study doctor to the results of the pH study until the end of a three month course of antireflux medication, and performing a second pH study to measure change in acid exposure.
Hypothesis: The Restech pH study helps identify patients who will respond positively to acid inhibitory therapy, and patients whose study normalizes will have better Symptomatic response rates than those whose pH levels fail to normalize.
1,066 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's planned enrollment of 150 is below the median of 180 across 298 observational studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →This is the only study on the registry with Respiratory Technology Corporation as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients presenting to the Otolaryngology practices of the co-investigators with certain symptoms consistent with Laryngopharyngeal reflux: hoarseness, globus sensation, and/or recurrent throat clearing for more than 3 months
Exclusion Criteria:
Symptomatic Improvement (treatment result) in the group of patients who are "LPR negative" (normal pH study) at baseline versus the symptomatic improvement of the patients who are "LPR positive" (abnormal pH study) at baseline.
After their first set of visits, the patients will be followed during their 3 month course of anti-reflux medications (PPIs). After three months, the patients will be asked to repeat the VAS and validated symptoms questionnaires. These will be compared to their baseline scores to measure symptomatic improvement. Using the criterion of 50% improvement in symptoms as the cutoff point (dividing factor), the two populations will be divided further into two groups: responders and non-responders. The amount of responders in each group will be compared to see if there is a greater proportion of responders in the group of patients who were LPR positive at baseline than in the group who were LPR negative at baseline.
Time frame: 12/2013 (up to 8 months)
No study locations are listed for this record.
This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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