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

Khon Kaen University

Status and phase: Completed; Phase 3

Conditions: Rhinitis

Treatments: Drug: Saline (Syringe irrigation); Drug: Cleanoze®

Study type: Interventional

Funder types: Other

Identifiers

NCT02763241

HE581519

Details and patient eligibility

About

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

Full 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

Enrollment: 115 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 2 patient groups

Cleanoze®

Experimental group

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 patient will be instructed to use this isotonic solution for nasal irrigation daily.

Treatment:

Drug: Cleanoze®

Syringe irrigation

Active Comparator group

Description:

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.

Treatment:

Drug: Saline (Syringe irrigation)