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Xylitol Versus Saline in Chronic Sinusitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lakshmi Durairaj, University of Iowa
ClinicalTrials.gov Identifier:
NCT00924404
First received: June 18, 2009
Last updated: July 10, 2017
Last verified: May 2017
Results First Received: May 31, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Sinusitis
Interventions: Drug: Xylitol
Drug: Saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Xylitol

isotonic xylitol for sinus rinse

Xylitol: 5% solution for sinus rinse

Saline

saline for sinus rinse

Saline: saline for sinus rinse


Participant Flow:   Overall Study
    Xylitol   Saline
STARTED   27   26 
COMPLETED   21   22 
NOT COMPLETED   6   4 
Lost to Follow-up                6                4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Xylitol

isotonic xylitol for sinus rinse

Xylitol: 5% solution for sinus rinse

Saline

saline for sinus rinse

Saline: saline for sinus rinse

Total Total of all reporting groups

Baseline Measures
   Xylitol   Saline   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   26   53 
Age 
[Units: Years]
Mean (Standard Deviation)
 51  (14)   55  (17)   54  (16) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      17  63.0%      20  76.9%      37  69.8% 
Male      10  37.0%      6  23.1%      16  30.2% 


  Outcome Measures

1.  Primary:   SNOT-20   [ Time Frame: 12 weeks ]

2.  Secondary:   Antibiotic Use   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   12/2020  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Lakshmi Durairaj
Organization: University of Iowa
phone: 319-353-7968
e-mail: lakshmi-durairaj@uiowa.edu



Responsible Party: Lakshmi Durairaj, University of Iowa
ClinicalTrials.gov Identifier: NCT00924404     History of Changes
Other Study ID Numbers: 200903757
Study First Received: June 18, 2009
Results First Received: May 31, 2017
Last Updated: July 10, 2017