RhinitisPhase 3NCT02763241
Cleanoze® Irrigation Device With Powder Preparation Versus Conventional Irrigation Method for Chronic Rhinitis
A Phase 3 study testing Cleanoze® and Saline (Syringe irrigation) in people with Rhinitis, run by Khon Kaen University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Rhinitis
- What is being tested?
- Cleanoze® and Saline (Syringe irrigation)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2016to Jan 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any patients with chronic rhinitis conditions regardless of any cause (e.g. allergic, irritant, infection)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Thailand1 site
Department of Otolaryngology, Khonkaen University
Muang, Khonkaen, 40002
About this study
Official title: Phase III Randomized Open-label Clinical Trial Comparing Cleanoze® Irrigation Device With Powder Preparation Versus Conventional Irrigation Method for Chronic Rhinitis
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
Read the 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
- Being tested
- Cleanoze®, Saline (Syringe irrigation)
- Keywords
- rhinitis
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Saline (Syringe irrigation)Drug
Nasal irrigation using 250 ml normal saline pushing into the nostril by 20 ml syringe
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Saline (Syringe irrigation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction score
This score will be evaluated at the end of 1 month using using the satisfaction questionaire
Measured: 1 month
Secondary outcomes (5)
The adherence to Cleanoze® devic
The adherence will be evaluated by the diary that the investigator given to the participants
Measured: 1 month
The durability of the Cleanoze® device
The durability will be evaluated by inspecting the device at the end of 1 month period
Measured: 1 month
The symptoms score of the patients
The symptoms score will be evaluated using the one-question VAS scale
Measured: 1 month
The Sino-Nasal Outcome Test-22 Questionnaire (SNOT-22) score
The SNOT-22 score will be evaluated by using SNOT-22 questionnaire
Measured: 1 month
Adverse events
The adverse events will be recorded in the case record form at follow-up time
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Collaborators
- Farmaline Co.,Ltd., Thailand
- Responsible party
- Principal investigator, Patorn Piromchai, Khon Kaen University
- Investigators
- Patorn Piromchai, MD, MSc, Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763241
- Sponsor's protocol ID
- HE581519
- Status last verified
- Aug 2018
- First submitted
- 29 Apr 2016
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Open-label Clinical Trial Comparing Cleanoze® Irrigation Device With Powder Preparation Versus Conventional Irrigation Method for Chronic Rhinitis
- ClinicalTrials.gov ID
- NCT02763241
- Acronym / sponsor ID
- HE581519
- Conditions
- Rhinitis
- Keywords
- rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Collaborators
- Farmaline Co.,Ltd., Thailand
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cleanoze® | Experimental | 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. The patient will be instructed to use this isotonic solution for nasal irrigation daily. |
| Syringe irrigation | Active comparator | Drug: Saline (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. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any patients with chronic rhinitis conditions regardless of any cause (e.g. allergic, irritant, infection)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Cleanoze® |
| Saline (Syringe irrigation)Nasal irrigation using 250 ml normal saline pushing into the nostril by 20 ml syringe | Drug | Syringe irrigation |
Primary outcome
Satisfaction score
Time frame: 1 month
This score will be evaluated at the end of 1 month using using the satisfaction questionaire
5 secondary outcomes
The adherence to Cleanoze® devic
Time frame: 1 month
The durability of the Cleanoze® device
Time frame: 1 month
The symptoms score of the patients
Time frame: 1 month
The Sino-Nasal Outcome Test-22 Questionnaire (SNOT-22) score
Time frame: 1 month
Adverse events
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patorn Piromchai, MD, MSc principal investigator
Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cleanoze® and Saline (Syringe irrigation) in people with Rhinitis, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction score (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.