Xylitol Versus Saline in Chronic Sinusitis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University of Iowa.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Iowa
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00924404
First received: June 18, 2009
Last updated: May 16, 2011
Last verified: May 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Sinusitis |
Drug: Xylitol Drug: Saline |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Controlled Trial of Xylitol Versus Saline Rinse For Chronic Sinusitis |
Resource links provided by NLM:
Further study details as provided by University of Iowa:
Primary Outcome Measures:
- SNOT-20 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- antibiotic use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 56 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Xylitol
isotonic xylitol for sinus rinse
|
Drug: Xylitol
5% solution for sinus rinse
|
|
Active Comparator: Saline
saline for sinus rinse
|
Drug: Saline
saline for sinus rinse
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00924404
Locations
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Janice L Launspach, R.N., CCRC 319-356-2047 janice-launspach@uiowa.edu | |
| Contact: Lakshmi Durairaj, M.D. 319-353-7968 lakshmi-durairaj@uiowa.edu | |
| Principal Investigator: Lakshmi Durairaj, M.D. | |
Sponsors and Collaborators
University of Iowa
Investigators
| Principal Investigator: | Lakshmi Durairaj, M.D. | University of Iowa |
More Information
No publications provided
| Responsible Party: | Lakshmi Durairaj, M.D., University of Iowa |
| ClinicalTrials.gov Identifier: | NCT00924404 History of Changes |
| Other Study ID Numbers: | IRB Protocol #200903757 |
| Study First Received: | June 18, 2009 |
| Last Updated: | May 16, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Iowa:
|
Xylitol sinusitis Comparing efficacy of twice daily xylitol nasal rinse with saline rinse which is current standard, comparing outcomes like quality of life and exacerbations |
Additional relevant MeSH terms:
|
Sinusitis Chronic Disease Paranasal Sinus Diseases Nose Diseases Respiratory Tract Diseases |
Respiratory Tract Infections Otorhinolaryngologic Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013