Xylitol Versus Saline in Chronic Sinusitis
This study has been completed.
Information provided by (Responsible Party):
Lakshmi Durairaj, University of Iowa
First received: June 18, 2009
Last updated: July 10, 2017
Last verified: May 2017
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.
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
||Randomized Controlled Trial of Xylitol Versus Saline Rinse For Chronic Sinusitis
Primary Outcome Measures:
- SNOT-20 [ Time Frame: 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 Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2014 (Final data collection date for primary outcome measure)
isotonic xylitol for sinus rinse
5% solution for sinus rinse
Active Comparator: Saline
saline for sinus rinse
saline for sinus rinse
Other Name: Salt solution
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
We now have two arms to this study.
Group I: Immunocompetent subjects with chronic rhinosinusitis
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.
- Cystic fibrosis
- Fungal sinusitis
- Immunocompromised status (use of long term oral steroids (> 30 days), AIDS, active malignancy or chemotherapy)
- Known Ciliary disorders
- Sinonasal tumors
Group 2: CRS with antibody deficiency
Cystic Fibrosis Sinonasal tumors Pregnancy
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00924404
|University of Iowa Hospitals and Clinics
|Iowa City, Iowa, United States, 52242 |
University of Iowa
||Lakshmi Durairaj, M.D.
||University of Iowa
||Lakshmi Durairaj, Assistant Professor, University of Iowa
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 18, 2009
|Results First Received:
||May 31, 2017
||July 10, 2017
Keywords provided by Lakshmi Durairaj, University of Iowa:
Comparing efficacy of twice daily xylitol nasal rinse with saline rinse presently current standard, comparing outcomes like quality of life and exacerbations
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 25, 2017
Paranasal Sinus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections