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

Study Overview
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Brief Summary
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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 Description
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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 analysis will take 3 additional months The full report will complete after the data analysis within 3 months The total of 1 year and 6 months period needed for this study. Primary Objective: To compare the satisfaction of the patients using Cleanoze® versus conventional device Secondary Objective(s): The adherence to Cleanoze® device The durability of the Cleanoze® device The patient symptom score (VAS) The SNOT-22 questionaire for evaluating the quality of life of the patients

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

Conditions
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Rhinitis

Intervention / Treatment
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* Drug: Cleanoze®
* Drug: Saline (Syringe irrigation)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patients with chronic rhinitis conditions regardless of any cause (e.g. allergic, irritant, infection) Exclusion Criteria: Acute or chronic rhinosinusitis Acute nasopharyngitis (common cold) Patients with a tendency to aspirate such as cerebrovascular accident, cranio-facial diseases. Sinunasal, nasopharyngeal and skull base tumors Age under 5 years old. Cannot administer a saline irrigation under the assistant of a care giver.

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cleanoze®<br>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 patient will be instructed to use this isotonic solution for nasal irrigation daily. | Drug: Cleanoze®<br>* 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.<br>|
| Active Comparator: Syringe irrigation<br>Nasal irrigation using sterile 0.9% NaCl 250 ml by 20 ml syringe The patient will be instructed to use this isotonic solution for nasal irrigation daily. | Drug: Saline (Syringe irrigation)<br>* Nasal irrigation using 250 ml normal saline pushing into the nostril by 20 ml syringe<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction score | This score will be evaluated at the end of 1 month using using the satisfaction questionaire | 1 month | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rhinitis