View Clinical Trial (Medical Research Study)
Randomized Controlled Trial of Xylitol Versus Saline Rinse For Chronic Sinusitis
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Iowa City |
| State: |
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Iowa |
| Zip Code: |
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52242 |
| Conditions: |
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Chronic Sinusitis |
| Purpose: |
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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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| Study Summary: |
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| Criteria: |
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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 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
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| NCT ID: |
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NCT00924404 |
| Primary Contact: |
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Principal Investigator
Lakshmi Durairaj, M.D.
University of Iowa
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| Backup Contact: |
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N/A |
| Location Contact: |
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Iowa City, Iowa 52242
United States
Janice L Launspach, R.N., CCRC
Phone: 319-356-2047
Email: janice-launspach@uiowa.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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