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| Name | Class |
|---|---|
| TAP Pharmaceutical Products Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lansoprazole | Active Comparator |
| |
| Sugar Pill | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lansoprazole Tablet | Drug | 40 mg bid x 16 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 8 weeks, and 16 weeks |
| Sino Nasal Outcome Test (SNOT-20) |
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Inclusion Criteria:
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)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael F Vaezi, MD PhD MS | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center, Vanderbilt Digestive Disease Clinic, TVC, Room 1660 | Nashville | Tennessee | 37232-5280 | United States |
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The PI and/or study coordinator or other GI research nurses will meet with the patients referred by Vanderbilt's Asthma, Sinus and Allergy Program. The patients will be given the consent form to read, the document will be reviewed, and all questions will be answered.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lansoprazole | 40 mg twice a day |
| FG001 | Placebo (Sugar Pill) | one tablet twice a day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lansoprazole | 40 mg twice a day |
| BG001 | Placebo (Sugar Pill) | one tablet twice a day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data. | Posted | Median | Inter-Quartile Range | Scores on a Scale | 8 and 16 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lansoprazole | 40 mg twice a day |
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Sample size of 75 participants is small. Lack of an objective measure of postnasal drainage limited the study outcome to be symptom based.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager, Clinical Trials | Vanderbilt University Medical Center | 615-322-4643 | tina.higginbotham@vanderbilt.edu |
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| ID | Term |
|---|---|
| D007818 | Laryngeal Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| D006863 | Hydrogen-Ion Concentration |
| D008365 | Manometry |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| PH and impedence testing | Procedure | 24 hour ph monitoring |
|
| manometry | Procedure | done prior to pH probe to measure length of esophagus |
|
| lansoprazole | Drug | 40mg bid |
|
| placebo | Drug | one tablet bid |
|
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. |
| 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. | Baseline, 8 weeks and 16 weeks |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo (Sugar Pill) |
one tablet twice a day |
|
|
|
| Secondary | 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. | Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data. | Posted | Median | Inter-Quartile Range | Scores on a Scale | Baseline, 8 weeks, and 16 weeks |
|
|
|
|
| Secondary | 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. | Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data. | Posted | Median | Inter-Quartile Range | Scores on a Scale | Baseline, 8 weeks and 16 weeks |
|
|
|
|
| Secondary | 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. | Analysis was performed per the protocol. At the completion of the study, all data were analyzed by the department of statistics and epidemiologyfor the primary outcome of interest, which was response rate for both lansoprazole and placebo. Univariate and multivariate analyses was performed on the collected data. | Posted | Median | Inter-Quartile Range | Scores on a Scale | Baseline, 8 weeks and 16 weeks |
|
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Placebo (Sugar Pill) | one tablet twice a day | 0 | 39 | 0 | 39 |
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| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D055598 | Chemical Phenomena |
| D008919 | Investigative Techniques |
| 16 weeks |
|
|
This applies to the 16 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate. |
| Regression, Logistic |
| .84 |
| Odds Ratio, log |
| 1.11 |
| 2-Sided |
| 95 |
| 0.40 |
| 3.06 |
| No |
| Superiority or Other |
| 16 weeks |
|
|
This applies to the 16 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate. |
| Regression, Logistic |
| .007 |
| Odds Ratio, log |
| 4.51 |
| 2-Sided |
| 95 |
| 1.5 |
| 13.6 |
| No |
| Superiority or Other |
| 16 weeks |
|
|
This applies to the 16 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate. |
| Regression, Logistic |
| .001 |
| Odds Ratio, log |
| 5.31 |
| 2-Sided |
| 95 |
| 1.97 |
| 14.3 |
| No |
| Superiority or Other |