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

Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02763241
• Other study ID #: HE581519
• Status: Completed
• Phase: Phase 3
• Start date: January 2016
• Est. completion date: January 2018

Study information

• Verified date: August 2018
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rhinitis

Intervention

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.
• Saline (Syringe irrigation)
Nasal irrigation using 250 ml normal saline pushing into the nostril by 20 ml syringe

Locations

Country	Name	City	State
Thailand	Department of Otolaryngology, Khonkaen University	Muang	Khonkaen

Sponsors (2)

Lead Sponsor	Collaborator
Khon Kaen University	Farmaline Co.,Ltd., Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

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