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Completed

NCT Number: NCT00924404

Xylitol Versus Saline in Chronic Sinusitis

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

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Key information

Conditions

Chronic Sinusitis Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections Sinusitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xylitol

Drug

5% solution for sinus rinse

Saline

Drug

saline for sinus rinse

Other names: Salt solution

Primary outcomes

  1. SNOT-20 Scores at 12 Weeks

    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 outcomes

  1. Mean Number of Antibiotic Courses During the Study Period

    Time frame: 12 weeks

    Mean Number of antibiotic courses for infection during the study period

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Official study title

Randomized Controlled Trial of Xylitol Versus Saline Rinse For Chronic Sinusitis

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jun 19, 2009
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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