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Chronic Sinusitis | Xylitol Versus Saline in Chronic Sinusitis

Chronic Sinusitis research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Chronic Sinusitis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Xylitol5% solution for sinus rinse

Drug:Salinesaline for sinus rinse

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Xylitolisotonic xylitol for sinus rinse

Salinesaline for sinus rinse

Study Status

Completed

Start Date: May 2009

Completed Date: August 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: SNOT-20 Scores at 12 Weeks

Secondary Outcome: Courses

Study sponsors, principal investigator, and references

Principal Investigator: Lakshmi Durairaj, M.D.

Lead Sponsor: University of Iowa

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00924404

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