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

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ClinicalTrials.gov Identifier: NCT02763241
Recruitment Status : Completed
First Posted : May 5, 2016
Last Update Posted : August 9, 2018
Sponsor:
Collaborator:
Farmaline Co.,Ltd., Thailand
Information provided by (Responsible Party):
Patorn Piromchai, Khon Kaen University

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

Condition or disease Intervention/treatment Phase
Rhinitis Drug: Cleanoze® Drug: Saline (Syringe irrigation) Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Randomized Open-label Clinical Trial Comparing Cleanoze® Irrigation Device With Powder Preparation Versus Conventional Irrigation Method for Chronic Rhinitis
Actual Study Start Date : January 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

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




Primary Outcome Measures :
  1. Satisfaction score [ Time Frame: 1 month ]
    This score will be evaluated at the end of 1 month using using the satisfaction questionaire


Secondary Outcome Measures :
  1. The adherence to Cleanoze® devic [ Time Frame: 1 month ]
    The adherence will be evaluated by the diary that the investigator given to the participants

  2. The durability of the Cleanoze® device [ Time Frame: 1 month ]
    The durability will be evaluated by inspecting the device at the end of 1 month period

  3. The symptoms score of the patients [ Time Frame: 1 month ]
    The symptoms score will be evaluated using the one-question VAS scale

  4. The Sino-Nasal Outcome Test-22 Questionnaire (SNOT-22) score [ Time Frame: 1 month ]
    The SNOT-22 score will be evaluated by using SNOT-22 questionnaire

  5. Adverse events [ Time Frame: 1 month ]
    The adverse events will be recorded in the case record form at follow-up time



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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02763241


Locations
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Thailand
Department of Otolaryngology, Khonkaen University
Muang, Khonkaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Farmaline Co.,Ltd., Thailand
Investigators
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Principal Investigator: Patorn Piromchai, MD, MSc Khon Kaen University
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Responsible Party: Patorn Piromchai, Assistance Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT02763241    
Other Study ID Numbers: HE581519
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Patorn Piromchai, Khon Kaen University:
rhinitis
Additional relevant MeSH terms:
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Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases