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

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

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 Overview

• Status: Completed
• Conditions: Rhinitis
• Intervention / Treatment: Drug: Cleanoze®; Drug: Saline (Syringe irrigation)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Khonkaen
    • Muang, Khonkaen, Thailand, 40002
      • Department of Otolaryngology, Khonkaen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cleanoze®; 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®; 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.
ACTIVE_COMPARATOR: Syringe irrigation; 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); Nasal irrigation using 250 ml normal saline pushing into the nostril by 20 ml syringe

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Khon Kaen University
• Collaborators: Farmaline Co.,Ltd., Thailand
• Investigators: Principal Investigator: Patorn Piromchai, MD, MSc, Khon Kaen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): January 1, 2018
• Study Completion (ACTUAL): January 1, 2018

Study Registration Dates

• First Submitted: April 29, 2016
• First Submitted That Met QC Criteria: May 4, 2016
• First Posted (ESTIMATE): May 5, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: rhinitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Rhinitis
• Other Study ID Numbers: HE581519

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO