Chronic Sinusitis Clinical Trial
Official title:
Randomized Controlled Trial of Xylitol Versus Saline Rinse For Chronic Sinusitis
NCT number | NCT00924404 |
Other study ID # | 200903757 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2009 |
Est. completion date | August 2014 |
Verified date | July 2018 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Is a xylitol nasal rinse better or worse than saline on patient satisfaction.
Status | Completed |
Enrollment | 53 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. Exclusion criteria: Cystic Fibrosis Sinonasal tumors Pregnancy |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
University of Iowa |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. |
12 weeks | |
Secondary | 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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