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Is a xylitol nasal rinse better or worse than saline on patient satisfaction.
In this pilot study, the investigators plan to compare the efficacy of twice daily xylitol nasal rinse with saline rinse which is the current standard, on outcomes such as quality of life and exacerbations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xylitol | Experimental | isotonic xylitol for sinus rinse |
|
| Saline | Active Comparator | saline for sinus rinse |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xylitol | Drug | 5% solution for sinus rinse |
| |
| Saline |
| Measure | Description | Time Frame |
|---|---|---|
| SNOT-20 Scores at 12 Weeks | Sinonasal outcome test is a 20 item quality of life questionnaire: Min-Max score range 0-100 The SNOT score for each patient was defined as the mean value of the response to the 20 items. The questionnaire is divided into 4 subsets, symptoms related to nose, symptoms of ear and face, sleep quality and psychological issues. Symptoms arereported on 100 mm visual analog scales (VASs) where 0 mm represents no symptoms and 100 mm represent "as troublesome as possible". The symptom severity is considered mild between 0 and 30, moderate from 30 to 70 and severe from 70- 100. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Antibiotic Courses During the Study Period | Mean Number of antibiotic courses for infection during the study period | 12 weeks |
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We now have two arms to this study.
Group I: Immunocompetent subjects with chronic rhinosinusitis
Inclusion Criteria:
56 Adult subjects (18 or older) presenting to the ENT(ears, nose, throat) clinics who meet the diagnosis of chronic rhinosinusitis (CRS). Definition of CRS: Presence of at least 2 of the following 4 signs/symptoms for 12 weeks or longer despite medical management:
In addition, objective evidence of sinus mucosal disease must be demonstrated on sinus CT imaging or direct endoscopic examination.
Exclusion Criteria:
Group 2: CRS with antibody deficiency
56 Adult subjects (18 or older) presenting to the Allergy clinic who meet the diagnosis of chronic rhinosinusitis (CRS). Definition of CRS: Presence of at least 2 of the following 4 signs/symptoms for 12 weeks or longer despite medical management:
In addition, objective evidence of sinus mucosal disease must be demonstrated on sinus CT imaging or direct endoscopic examination.
Exclusion criteria:
Cystic Fibrosis Sinonasal tumors Pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Lakshmi Durairaj, M.D. | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Xylitol | isotonic xylitol for sinus rinse Xylitol: 5% solution for sinus rinse |
| FG001 | Saline | saline for sinus rinse Saline: saline for sinus rinse |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Xylitol | isotonic xylitol for sinus rinse Xylitol: 5% solution for sinus rinse |
| BG001 | Saline | saline for sinus rinse Saline: saline for sinus rinse |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | SNOT-20 Scores at 12 Weeks | Sinonasal outcome test is a 20 item quality of life questionnaire: Min-Max score range 0-100 The SNOT score for each patient was defined as the mean value of the response to the 20 items. The questionnaire is divided into 4 subsets, symptoms related to nose, symptoms of ear and face, sleep quality and psychological issues. Symptoms arereported on 100 mm visual analog scales (VASs) where 0 mm represents no symptoms and 100 mm represent "as troublesome as possible". The symptom severity is considered mild between 0 and 30, moderate from 30 to 70 and severe from 70- 100. | We initially enrolled 53 subjects but we had 10 subjects drop out of the study. | Posted | Mean | Standard Deviation | units on a scale | 12 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 | Xylitol | isotonic xylitol for sinus rinse Xylitol: 5% solution for sinus rinse |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lakshmi Durairaj | University of Iowa | 319-353-7968 | lakshmi-durairaj@uiowa.edu |
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| ID | Term |
|---|---|
| D012852 | Sinusitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
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| ID | Term |
|---|---|
| D014993 | Xylitol |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| Drug |
saline for sinus rinse |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Saline | saline for sinus rinse Saline: saline for sinus rinse |
|
|
| Secondary | Mean Number of Antibiotic Courses During the Study Period | Mean Number of antibiotic courses for infection during the study period | Posted | Mean | Standard Deviation | mean number of antibiotic courses during | 12 weeks |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Saline | saline for sinus rinse Saline: saline for sinus rinse | 0 | 22 | 0 | 22 | 0 | 22 |
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| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |