Clinical trial NCT02763241: Cleanoze® Irrigation Device With Powder Preparation Versus Conventional Irrigation Method for Chronic Rhinitis
Official title: Phase III Randomized Open-label Clinical Trial Comparing Cleanoze® Irrigation Device With Powder Preparation Versus Conventional Irrigation Method for Chronic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis
Keywords: rhinitis
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
Collaborators: name: Farmaline Co.,Ltd., Thailand
First posted: 2016-05-05
Enrollment: 115
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Satisfaction score
timeFrame: 1 month
Secondary outcomes:
measure: The adherence to Cleanoze® devic
timeFrame: 1 month
measure: The durability of the Cleanoze® device
timeFrame: 1 month
measure: The symptoms score of the patients
timeFrame: 1 month
measure: The Sino-Nasal Outcome Test-22 Questionnaire (SNOT-22) score
timeFrame: 1 month
measure: Adverse events
timeFrame: 1 month
Other outcomes:
Locations:
city: Muang
country: Thailand
facility: Department of Otolaryngology, Khonkaen University
state: Khonkaen
Study officials:
affiliation: Khon Kaen University
name: Patorn Piromchai, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: