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

NCT02763241 | Completed Phase 3

• 1 other identifier: HE581519
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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

Conditions

Rhinitis

Keywords

rhinitis

Outcome Measures

Primary Outcomes (1)

• Satisfaction score

  This score will be evaluated at the end of 1 month using using the satisfaction questionaire

  1 month

Secondary Outcomes (5)

• The adherence to Cleanoze® devic

  1 month

• The durability of the Cleanoze® device

  1 month

• The symptoms score of the patients

  1 month

• The Sino-Nasal Outcome Test-22 Questionnaire (SNOT-22) score

  1 month

• Adverse events

  1 month

Study Arms (2)

Cleanoze®

EXPERIMENTAL

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®

Syringe irrigation

ACTIVE COMPARATOR

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)

Interventions

Cleanoze® 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.

Cleanoze®

Saline (Syringe irrigation) DRUG

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

Syringe irrigation

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patients with chronic rhinitis conditions regardless of any cause (e.g. allergic, irritant, infection)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Khon Kaen University: lead
• Farmaline Co.,Ltd., Thailand: collaborator

Study Sites (1)

Department of Otolaryngology, Khonkaen University

Muang, Khonkaen, 40002, Thailand

Location

MeSH Terms

Conditions

Rhinitis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Patorn Piromchai, MD, MSc

  Khon Kaen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistance Professor

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: May 5, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: August 9, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)