Laryngopharyngeal RefluxNCT01829074
Predictive Value of Subjective and Objective Measurement Tools for Extraesophageal Reflux
An observational study of Laryngopharyngeal Reflux, run by Respiratory Technology Corporation.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Laryngopharyngeal Reflux
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- Presenting to the ENT clinic for distressing symptoms of hoarseness, laryngitis, and/or recurrent throat clearing for at least 3 months duration. Determined not to be caused by another factor, such as allergies or poor vocal hygiene.
- Laryngoscopic examination performed on day of enrollment
- Indications present for a 24 hour oropharyngeal pH study (Restech)
- Indication to begin a 3 month course of antireflux therapy (Figure 1) based on symptom presentation and widely accepted otolaryngologic findings
- Willing to return to clinic in 3 months for follow up pH study
- Willing to participate in weekly phone calls with the study investigator to discuss compliance with medication and lifestyle modifications.
Who cannot join
- Expected non-compliance with the equipment and/or instructions (according the protocol) given by the investigator.
- Any subjects with significant medical conditions that, in the investigator's judgment, would compromise the subject's health and safety.
- Subjects who have undergone previous antireflux surgery
- Subjects treated for reflux, either with Proton Pump Inhibitors (PPI's) or H2RAs in the past 4 weeks
- Subjects previously treated for reflux, either with antireflux medication or surgery
- Subjects with alternative work schedules affecting nighttime sleep periods (i.e. nighttime shift employees)
- Subjects with conditions that contraindicate use of PPIs, as listed on product labeling.
- Women who are pregnant, or nursing.
About this study
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.
Read more
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.
- Conditions
- Laryngopharyngeal Reflux
- Keywords
- Laryngopharyngeal Reflux, Hoarseness, Throat Clearing, Globus Sensation
- Medical subject headings
- Laryngopharyngeal Reflux, Hoarseness, Globus Sensation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12/2013 (up to 8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngopharyngeal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Respiratory Technology Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nimish Vakil, MD, Principal investigator, University of Wisconsin, Madison, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829074
- Sponsor's protocol ID
- 13RT001
- Status last verified
- Apr 2013
- First submitted
- 2 Apr 2013
- Last updated
- 11 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Subjective and Objective Measurement Tools for Extraesophageal Reflux
- ClinicalTrials.gov ID
- NCT01829074
- Acronym / sponsor ID
- 13RT001
- Conditions
- Laryngopharyngeal Reflux
- Keywords
- Laryngopharyngeal Reflux, Hoarseness, Throat Clearing, Globus Sensation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Respiratory Technology CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 11 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (6 listed)
- Presenting to the ENT clinic for distressing symptoms of hoarseness, laryngitis, and/or recurrent throat clearing for at least 3 months duration. Determined not to be caused by another factor, such as allergies or poor vocal hygiene.
- Laryngoscopic examination performed on day of enrollment
- Indications present for a 24 hour oropharyngeal pH study (Restech)
- Indication to begin a 3 month course of antireflux therapy (Figure 1) based on symptom presentation and widely accepted otolaryngologic findings
- Willing to return to clinic in 3 months for follow up pH study
Key exclusion criteria (8 listed)
- Expected non-compliance with the equipment and/or instructions (according the protocol) given by the investigator.
- Any subjects with significant medical conditions that, in the investigator's judgment, would compromise the subject's health and safety.
- Subjects who have undergone previous antireflux surgery
- Subjects treated for reflux, either with Proton Pump Inhibitors (PPI's) or H2RAs in the past 4 weeks
- Subjects previously treated for reflux, either with antireflux medication or surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 12/2013 (up to 8 months)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nimish Vakil, MD principal investigator
University of Wisconsin, Madison, USA
Questions about this trial
What is this clinical trial studying?
An observational study of Laryngopharyngeal Reflux, run by Respiratory Technology Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12/2013 (up to 8 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2013.