Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00924404
Other study ID # 200903757
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2009
Est. completion date August 2014

Study information

Verified date July 2018
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Xylitol
5% solution for sinus rinse
Saline
saline for sinus rinse

Locations

Country Name City State
United States University of Iowa Hospitals and Clinics Iowa City Iowa

Sponsors (1)

Lead Sponsor Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary SNOT-20 Scores at 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.
12 weeks
Secondary Mean Number of Antibiotic Courses During the Study Period Mean Number of antibiotic courses for infection during the study period 12 weeks
See also
  Status Clinical Trial Phase
Completed NCT02266810 - Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus Phase 3
Completed NCT01706484 - Efficacy and Safety of Two Dosages of a Herbal Medicinal Product (Dry Extract BNO 1016) in Chronic Rhinosinusitis Phase 3
Completed NCT01197612 - Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis Phase 3
Completed NCT04163978 - Nitric Oxide Releasing Sinus Irrigation (NOSi) to Treat Recalcitrant Chronic Rhinosinusitis (RCRS) Phase 2
Completed NCT04418622 - Evolution of the Endonasal Microbiota in Patients With Chronic Rhinosinusitis
Not yet recruiting NCT06070311 - Wound Healing After Endoscopic Sinus Surgery N/A
Not yet recruiting NCT05454163 - Post-radiotherapy Rhinosinusitis in Children
Withdrawn NCT01185808 - Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps N/A
Completed NCT01700725 - Gulf War Illness Nasal Irrigation Study Phase 2
Withdrawn NCT00671281 - The Effect of Tranexamic Acid on Intraoperative and Post-Operative Bleeding in Functional Endoscopic Sinus Surgery N/A
Completed NCT00447837 - Evaluating SPRC-AB01 in Post-Surgical Subjects With Chronic Sinusitis Phase 2
Recruiting NCT04362501 - Efficacy of Dupilumab for Patients With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) Phase 2
Completed NCT05035654 - LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study) Phase 2
Completed NCT02562924 - The Efficacy of MEDIHONEY® for Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery N/A
Completed NCT01007799 - Vitamin D for Chronic Sinusitis N/A
Completed NCT03358329 - Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE) Phase 3
Withdrawn NCT02981017 - Improvement of Outcomes in Draf III/Endoscopic Modified Lothrop Procedure N/A
Completed NCT04041609 - LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study) Phase 2
Recruiting NCT01854619 - Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis N/A
Not yet recruiting NCT03903432 - The Feasibility of Using MRI During ESS N/A