Larynx DiseasePhase 3PNDNCT00335283
Efficacy of Lansoprazole in Chronic Post Nasal Drip
A Phase 3 study testing Lansoprazole Tablet, PH and impedence testing and manometry in people with Larynx Disease, run by Vanderbilt University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether aggressive acid suppression with Lansoprazole is effective in the treatment of post nasal drip, and also assess the predictors of response based on clinical and physiologic parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Larynx Disease
- What is being tested?
- Lansoprazole Tablet, PH and impedence testing and manometry
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Dec 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Negative RAST inhalant allergy panel OR negative skin testing (Group A)
- Positive RAST or Positive skin testing AND insufficient response to all of the following: (Group B)
- Allergen avoidance
- Topical nasal steroids
- Allergy shots if indicated
- Antihistamines
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- Negative CT sinuses (coronal)
- < 4mm of mucosal thickening and < 3 sinus sites
- Absence of air-fluid levels
- Negative anterior rhinoscopy
- Absence of pus, crusts on mucosal surfaces
Who cannot join
- Age < 18
- Pregnancy, confirmed by urine pregnancy test at day of randomization
- Ciliary dyskinesia
- Immune deficiency
- Cystic fibrosis
- Diagnosis of acute sinusitis or chronic RS (AAO-HNS)
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- Active use of topical decongestant
- Use of PPI within the last 30 days
- Previous fundoplication
- Uncontrolled thyroid disease
- Isolated chronic cough without the symptom of post nasal drip
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center, Vanderbilt Digestive Disease Clinic, TVC, Room 1660
Nashville, Tennessee, 37232-5280
About this study
Official title: Randomized Placebo-Controlled Trial of BID Lansoprazole in Isolated Chronic Post Nasal Drip
The purpose of this study is to determine whether aggressive acid suppression with Lansoprazole is effective in the treatment of post nasal drip, and also assess the predictors of response based on clinical and physiologic parameters.
Read the detailed description
Postnasal drip (PND) is a common complaint that brings patients to the attention of their primary care physicians. It is also one of the most common reasons for patients to seek care from otolaryngologists. Traditionally, PND has been considered and treated as a symptom of sinonasal pathology. It has also been shown, along with Gastroesophageal reflux disease (GERD) and asthma, to be a major contributor to the development of chronic cough. PND refractory to treatment aimed at sinonasal disease is sometimes treated with anti-GERD therapy. This treatment modality is based on clinical experience. To date, there are no studies in the literature to support a causal relationship between PND and extraesophageal reflux (EER). In a case control study of patients with and without esophagitis El-Serag et al reported a significant association (odds ratio 1.6, 95%CI 1.4-1.8) between sinusitis and GERD. A later study by Ulualp et al in 11 CT confirmed cases of chronic sinusitis resistant to therapy with conventional sinus therapies they found a significantly higher prevalence of hypopharyngeal acid exposure in the sinusitis group than controls. Recently, in an open label prospective pilot trial, DiBaise et al treated 11 patients with sinusitis and 19 GERD patients with omeprazole 20mg bid for 3-months. 9/11 sinusitis patients were found to have GERD by pH monitoring and there was moderate (25-89%) improvement in the sinus symptoms in the omeprazole treated group. However, there are currently no placebo-controlled trials assessing efficacy of PPI's in patients with PND.
- Conditions
- Larynx Disease
- Being tested
- Lansoprazole Tablet, PH and impedence testing, manometry, lansoprazole, placebo
- Medical subject headings
- Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lansoprazole TabletDrug
Also called prevacid
40 mg bid x 16 weeks
PH and impedence testingProcedure or surgery
24 hour ph monitoring
manometryProcedure or surgery
done prior to pH probe to measure length of esophagus
lansoprazoleDrug
40mg bid
placeboDrug
one tablet bid
| Study group | Role | What they receive |
|---|---|---|
| Lansoprazole | Active comparator | Not described Receives: Drug: Lansoprazole Tablet; Procedure: PH and impedence testing; Procedure: manometry; Drug: lansoprazole |
| Sugar Pill | Placebo comparator | Not described Receives: Procedure: PH and impedence testing; Procedure: manometry; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Nasal Drainage Symptom Response
The primary outcome measure was postnasal drainage symptom response measured by using a visual analogue scale. At 8 and 16 weeks, a horizontal symptoms scale from 0% (no change) to 100% (symptoms completely resolved) was presented to participants to assess improvement in postnasal drainage symptoms.
Measured: 8 and 16 weeks
Secondary outcomes (3)
Rhinosinusitis Outcome Measure(RSOM-31)
RSOM-31 includes 31 questions combined into a total score ranging from 0 to 155 with higher scores representing greater disease burden. Values are based on patient report.
Measured: Baseline, 8 weeks, and 16 weeks
Sino Nasal Outcome Test (SNOT-20)
SNOT-20 includes 20 questions combined into a total score ranging from 0 to 100 with higher numbers representing greater rhinosinusitis health burden and represents patient-reported symptom severity.
Measured: Baseline, 8 weeks and 16 weeks
Quality of Life Questionnaire (QOLRAD)
The patient-reported QOLRAD consists of 25 questions combined into a total score ranging from 25 to 175 with higher numbers representing better quality of life.
Measured: Baseline, 8 weeks and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2006 (estimated)
- Study startAug 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Larynx DiseaseStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- TAP Pharmaceutical Products Inc.
- Responsible party
- Principal investigator, Michael Vaezi, Vanderbilt University
- Investigators
- Michael F Vaezi, MD PhD MS, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335283
- Sponsor's protocol ID
- 051169
- Acronym
- PND
- Status last verified
- Jun 2012
- First submitted
- 7 Jun 2006
- Last updated
- 21 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-Controlled Trial of BID Lansoprazole in Isolated Chronic Post Nasal Drip
- ClinicalTrials.gov ID
- NCT00335283
- Acronym / sponsor ID
- PND / 051169
- Conditions
- Larynx Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- TAP Pharmaceutical Products Inc.
- Study start
- Aug 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 9 Jun 2006 (estimated)
- Results
- Posted 21 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether aggressive acid suppression with Lansoprazole is effective in the treatment of post nasal drip, and also assess the predictors of response based on clinical and physiologic parameters.
Detailed description
Postnasal drip (PND) is a common complaint that brings patients to the attention of their primary care physicians. It is also one of the most common reasons for patients to seek care from otolaryngologists. Traditionally, PND has been considered and treated as a symptom of sinonasal pathology. It has also been shown, along with Gastroesophageal reflux disease (GERD) and asthma, to be a major contributor to the development of chronic cough. PND refractory to treatment aimed at sinonasal disease is sometimes treated with anti-GERD therapy. This treatment modality is based on clinical experience. To date, there are no studies in the literature to support a causal relationship between PND and extraesophageal reflux (EER). In a case control study of patients with and without esophagitis El-Serag et al reported a significant association (odds ratio 1.6, 95%CI 1.4-1.8) between sinusitis and GERD. A later study by Ulualp et al in 11 CT confirmed cases of chronic sinusitis resistant to therapy with conventional sinus therapies they found a significantly higher prevalence of hypopharyngeal acid exposure in the sinusitis group than controls. Recently, in an open label prospective pilot trial, DiBaise et al treated 11 patients with sinusitis and 19 GERD patients with omeprazole 20mg bid for 3-months. 9/11 sinusitis patients were found to have GERD by pH monitoring and there was moderate (25-89%) improvement in the sinus symptoms in the omeprazole treated group. However, there are currently no placebo-controlled trials assessing efficacy of PPI's in patients with PND.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lansoprazole | Active comparator | Drug: Lansoprazole Tablet, Procedure: PH and impedence testing, Procedure: manometry, Drug: lansoprazole |
| Sugar Pill | Placebo comparator | Procedure: PH and impedence testing, Procedure: manometry, Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Negative RAST inhalant allergy panel OR negative skin testing (Group A)
- Positive RAST or Positive skin testing AND insufficient response to all of the following: (Group B)
Key exclusion criteria (11 listed)
- Age < 18
- Pregnancy, confirmed by urine pregnancy test at day of randomization
- Ciliary dyskinesia
- Immune deficiency
- Cystic fibrosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lansoprazole TabletAlso: prevacid40 mg bid x 16 weeks | Drug | Lansoprazole |
| PH and impedence testing24 hour ph monitoring | Procedure or surgery | Lansoprazole, Sugar Pill |
| manometrydone prior to pH probe to measure length of esophagus | Procedure or surgery | Lansoprazole, Sugar Pill |
| lansoprazole40mg bid | Drug | Lansoprazole |
| placeboone tablet bid | Drug | Sugar Pill |
Primary outcome
Post Nasal Drainage Symptom Response
Time frame: 8 and 16 weeks
The primary outcome measure was postnasal drainage symptom response measured by using a visual analogue scale. At 8 and 16 weeks, a horizontal symptoms scale from 0% (no change) to 100% (symptoms completely resolved) was presented to participants to assess improvement in postnasal drainage symptoms.
3 secondary outcomes
Rhinosinusitis Outcome Measure(RSOM-31)
Time frame: Baseline, 8 weeks, and 16 weeks
Sino Nasal Outcome Test (SNOT-20)
Time frame: Baseline, 8 weeks and 16 weeks
Quality of Life Questionnaire (QOLRAD)
Time frame: Baseline, 8 weeks and 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael F Vaezi, MD PhD MS principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lansoprazole Tablet, PH and impedence testing and manometry in people with Larynx Disease, run by Vanderbilt University at 1 site in United States.
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 11 inclusion and 11 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: finished, as of the sponsor's last update on 21 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post Nasal Drainage Symptom Response (time frame: 8 and 16 weeks). 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 21 Aug 2012.