Xylitol Versus Saline in Chronic Sinusitis



Status:Completed
Conditions:Sinusitis
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:18 - Any
Updated:9/2/2018
Start Date:May 2009
End Date:August 2014

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Randomized Controlled Trial of Xylitol Versus Saline Rinse For Chronic Sinusitis

Is a xylitol nasal rinse better or worse than saline on patient satisfaction.

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.

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
We found this trial at
1
site
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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