Chronic Sinusitis
Conditions
Keywords
Xylitol vs. Saline, nasal washes, sinusitis
Brief summary
Is a xylitol nasal rinse better or worse than saline on patient satisfaction.
Detailed description
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.
Interventions
DRUGXylitol
5% solution for sinus rinse
DRUGSaline
saline for sinus rinse
Sponsors
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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: * Anterior and/or posterior mucopurulent drainage * Nasal obstruction * Facial pain, pressure, and/or fullness * Decreased sense of smell * In addition, objective evidence of sinus mucosal disease must be demonstrated on sinus CT imaging or direct endoscopic examination.
Exclusion criteria
* Cystic fibrosis * Fungal sinusitis * Immunocompromised status (use of long term oral steroids (\> 30 days), AIDS, active malignancy or chemotherapy) * Known Ciliary disorders * Sinonasal tumors * Pregnancy 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: * Anterior and/or posterior mucopurulent drainage * Nasal obstruction * Facial pain, pressure, and/or fullness * Decreased sense of smell * In addition, objective evidence of sinus mucosal disease must be demonstrated on sinus CT imaging or direct endoscopic examination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SNOT-20 Scores at 12 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Antibiotic Courses During the Study Period | 12 weeks | Mean Number of antibiotic courses for infection during the study period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Xylitol isotonic xylitol for sinus rinse
Xylitol: 5% solution for sinus rinse | 27 |
| Saline saline for sinus rinse
Saline: saline for sinus rinse | 26 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 4 |
Baseline characteristics
| Characteristic | Xylitol | Saline | Total |
|---|---|---|---|
| Age, Continuous | 51 years STANDARD_DEVIATION 14 | 55 years STANDARD_DEVIATION 17 | 54 years STANDARD_DEVIATION 16 |
| Sex: Female, Male Female | 17 Participants | 20 Participants | 37 Participants |
| Sex: Female, Male Male | 10 Participants | 6 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 22 |
| other Total, other adverse events | 0 / 21 | 0 / 22 |
| serious Total, serious adverse events | 0 / 21 | 0 / 22 |
Outcome results
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.
Time frame: 12 weeks
Population: We initially enrolled 53 subjects but we had 10 subjects drop out of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Xylitol | SNOT-20 Scores at 12 Weeks | 7 units on a scale | Standard Deviation 15 |
| Saline | SNOT-20 Scores at 12 Weeks | 11 units on a scale | Standard Deviation 16 |
Secondary
Mean Number of Antibiotic Courses During the Study Period
Mean Number of antibiotic courses for infection during the study period
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Xylitol | Mean Number of Antibiotic Courses During the Study Period | 1.90 mean number of antibiotic courses during | Standard Deviation 0.3 |
| Saline | Mean Number of Antibiotic Courses During the Study Period | 1.77 mean number of antibiotic courses during | Standard Deviation 0.43 |