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

NCT ID: NCT02763241

Last Updated: 2018-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-01-31

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 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

Conditions

Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cleanoze®

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Saline (Syringe irrigation)

Intervention Type: DRUG

Nasal irrigation using 250 ml normal saline pushing into the nostril by 20 ml syringe

Interventions

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.

Intervention Type: DRUG

Saline (Syringe irrigation)

Nasal irrigation using 250 ml normal saline pushing into the nostril by 20 ml syringe

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Farmaline Co.,Ltd., Thailand

UNKNOWN

Sponsor Role: collaborator

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Patorn Piromchai

Assistance Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patorn Piromchai, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Khon Kaen University

Locations

Department of Otolaryngology, Khonkaen University

Muang, Khonkaen, Thailand

Countries

Thailand

Other Identifiers

HE581519

Identifier Type: -

Identifier Source: org_study_id