Clinical Trial: Cleanoze® Irrigation Device With Powder Preparation Versus Conventional Irrigation Method for Chronic Rhinitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase III Randomized Open-label Clinical Trial Comparing Cleanoze® Irrigation Device With Powder Preparation Versus Conventional Irrigation Method for Chronic Rhinitis

Brief Summary: The investigators proposed that the Cleanoze® is superior to the traditional nasal saline irrigation in term of the ease of use which will resulting in a better quality of life of the participants. This study will compared the efficacy, adverse reactions, complications and ease of use of Cleanoze® comparing with normal saline solution

Detailed Summary:

Cleanoze® consists of a powder made up of Sodium chloride and Sodium Bicarbonate. This powder when dissolved in 250 ml of water is closely resembles the content of a body fluid which normally baths the outside of the cells of the body. This fluid is isotonic solution.

The nasal saline irrigation is the common procedure for upper respiratory tract infection patients including chronic rhinitis. The physician usually order the normal saline with appropriate medication e.g. anti-histamines, nasal steroids and anti-biotics to treat this condition.

The investigators proposed that the Cleanoze® is superior to the traditional nasal saline irrigation in term of the ease of use which will resulting in a better quality of life of the participants. This study will compared the efficacy, adverse reactions, complications and ease of use of Cleanoze® comparing with normal saline solution.

Study Population: Any patients with chronic rhinitis (e.g. allergic rhinitis, vasomotor rhinitis) will be randomized to receive the study or control medication. The investigators will include the children 5 years and above which able to doing the lavage under the parents assistant or by them self.

Study Design: Phase III randomized controlled trial

Sample Size: Estimate from pilot study, the 71 patients per arm was estimated (142 participants totally).

Study Duration:

• Duration of enrollment is 1 year.
• The patients will be followed up to 1 months depend on the disease conditions.
• The data analy
  Sponsor: Khon Kaen University
  

  Current Primary Outcome: Satisfaction score [ Time Frame: 1 month ]

  This score will be evaluated at the end of 1 month using using the satisfaction questionaire
  
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:

  • The adherence to Cleanoze® devic [ Time Frame: 1 month ]
    The adherence will be evaluated by the diary that the investigator given to the participants
  • The durability of the Cleanoze® device [ Time Frame: 1 month ]
    The durability will be evaluated by inspecting the device at the end of 1 month period
  • The symptoms score of the patients [ Time Frame: 1 month ]
    The symptoms score will be evaluated using the one-question VAS scale
  • The Sino-Nasal Outcome Test-22 Questionnaire (SNOT-22) score [ Time Frame: 1 month ]
    The SNOT-22 score will be evaluated by using SNOT-22 questionnaire
  • Adverse events [ Time Frame: 1 month ]
    The adverse events will be recorded in the case record form at follow-up time
  
  
  

  Original Secondary Outcome: Same as current
  
  Information By: Khon Kaen University
  

  Dates:
  Date Received: April 29, 2016
  Date Started: January 2016
  Date Completion: January 2017
  Last Updated: May 4, 2016
  Last Verified: May 2016