Chronic RhinosinusitisNCT06108921
Efficacy and Safety of Xylitol Nasal Irrigation After Functional Endoscopic Sinus Surgery
A study testing Xylitol Powder and Salt Powder in people with Chronic Rhinosinusitis and Postoperative Care, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
Investigators tried to evaluate the efficacy and safety of xylitol nasal irrigation as an adjuvant therapy after FESS, particularly the influence of nasal irrigation on Eustachian tube function. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Rhinosinusitis, Postoperative Care
- What is being tested?
- Xylitol Powder and Salt Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2020to 30 Sep 2023
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic rhinosinusitis who failed medical treatment
- Patients underwent bilateral primary functional endoscopic sinus surgery.
Who cannot join
- Patients with a history of immunodeficiency
- Patients with a history of sinus surgery
- Patients who receiving antibiotic treatment within a week before functional endoscopic sinus surgery
- Patients with a pathological diagnosis of fungal sinusitis
- Patients with a pathological diagnosis of sinonasal tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Xylitol Nasal Irrigation After Functional Endoscopic Sinus Surgery: A Randomized Controlled Study
Investigators tried to evaluate the efficacy and safety of xylitol nasal irrigation as an adjuvant therapy after FESS, particularly the influence of nasal irrigation on Eustachian tube function.
Read the detailed description
In this study, patients with chronic rhinosinusitis who received FESS were recruited and randomly assigned to 2 groups at one month post-surgery. Patients in the xylitol group received 400ml of 5% xylitol nasal irrigation daily for 2 months, and those in the normal saline (NS) group received 400ml of NS nasal irrigation daily for 2 months. Before FESS as well as before and after nasal irrigation, sino-nasal symptoms were assessed by a 22-item Sino-Nasal Outcome Test questionnaire and patients received endoscopic examination, nasal function tests, cytokine measurement of nasal irrigant, and bacterial culture from the middle meatus. The safety of nasal irrigation was assessed by self-reported adverse events, blood test, Eustachian Tube Dysfunction Patient Questionnaire and Eustachian tube function test. This study tried to evaluate the efficacy and safety of xylitol nasal irrigation as an adjuvant therapy after FESS, particularly the influence of nasal irrigation on Eustachian tube function.
- Conditions
- Chronic Rhinosinusitis, Postoperative Care
- Being tested
- Xylitol Powder, Salt Powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xylitol PowderDrug
The bilateral nasal cavity was irrigated by using a Sanvic SH903 pulsatile irrigator containing 400 ml of xylitol solution once a day for 2 months.
Salt PowderDrug
The bilateral nasal cavity was irrigated by using a Sanvic SH903 pulsatile irrigator containing 400 ml of normal saline once a day for 2 months.
| Study group | Role | What they receive |
|---|---|---|
| xylitol | Experimental | In the xylitol group, 5% xylitol solutions were first prepared by mixing two packs of 10 mg xylitol powder with 400 mL of sterile water in the container of the irrigator. Nasal irrigation was performed by using a Sanvic SH903 pulsatile irrigator (Yun-Wang Industrial Co., Tainan, Taiwan). When irrigating the nose, patients irrigated both of their nasal cavities each with 200 mL of solutions once a day. Patients performed nasal irrigations for 2 months. Receives: Drug: Xylitol Powder |
| saline | Placebo comparator | In the saline group, the normal saline solution was prepared by mixing 2 packs of 1.8 mg salt powder with 400 mL of sterile water in the container of the irrigator. Nasal irrigation was performed by using a Sanvic SH903 pulsatile irrigator (Yun-Wang Industrial Co., Tainan, Taiwan). When irrigating the nose, patients irrigated both of their nasal cavities each with 200 mL of solutions once a day. Patients performed nasal irrigations for 2 months. Receives: Drug: Salt Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taiwanese version of the 22-item Sino-Nasal Outcome Test
The Taiwanese version of the 22-item Sino-Nasal Outcome Test contains 22 items of symptoms and social/emotional consequences from nasal disorder. Patients are asked to rate their problems based on how they have been over the past two weeks. Each item is graded from 0 (no problem) to 5 (as bad as it can be) according to its severity and frequency.
Measured: From before operation to 3 months after surgery
Self-reported adverse events
Any adverse events occurring during the 2 months period of nasal irrigation
Measured: From before nasal irrigation to after 2-month nasal irrigation
Secondary outcomes (5)
Change of the second minimal cross-sectional area of the nasal cavity
The second minimal cross-sectional area of the nasal cavity was measured by acoustic rhinometry.
Measured: From before operation to 3 months after surgery
Change of endoscopic score
The endoscopic appearances were categorized into polyps (0: no polyps; 1: polyps present within the middle meatus; 2: polyps beyond the middle meatus); nasal secretion (0: no secretion; 1: clear, thin secretion; 2: thick, purulent secretion); mucosal edema; scarring; crusting; (0: absent; 1: mild; 2: severe). The score ranged from 0 to 20 for both nostrils together.
Measured: From before operation to 3 months after surgery
Change of saccharine transit time
The saccharine transit test involved placing saccharine granules under the head of the inferior turbinate in the more severely affected nostril. The time interval (minute) between placement of saccharine granules and sensation of sweetness in the throat was recorded.
Measured: From before operation to 3 months after surgery
Change of score measured by Eustachian Tube Dysfunction Patient Questionnaire
Using a 7-item Eustachian Tube Dysfunction Patient Questionnaire to evaluate Eustachian tube function
Measured: From before nasal irrigation to after 2-month nasal irrigation
Change of Eustachian Tube function by the nine-step inflation/deflation test
Failure to alter the pressure of middle ear at least 10 daPa with swallowing during any of the steps was considered ETD (tuba1 function was 'Poor'). If the equilibration was successful (observed pressure change >10 daPa) in all steps, Eustachian tube function was considered 'Good'.
Measured: From before nasal irrigation to after 2-month nasal irrigation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Feb 2020
- Primary completion28 Feb 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinosinusitisStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rong-San Jiang, MD, PhD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108921
- Sponsor's protocol ID
- CF19287A
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Outcome measures
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Xylitol Nasal Irrigation After Functional Endoscopic Sinus Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06108921
- Acronym / sponsor ID
- CF19287A
- Conditions
- Chronic Rhinosinusitis, Postoperative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 31 Oct 2023 (actual)
- 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.
Investigators tried to evaluate the efficacy and safety of xylitol nasal irrigation as an adjuvant therapy after FESS, particularly the influence of nasal irrigation on Eustachian tube function.
Detailed description
In this study, patients with chronic rhinosinusitis who received FESS were recruited and randomly assigned to 2 groups at one month post-surgery. Patients in the xylitol group received 400ml of 5% xylitol nasal irrigation daily for 2 months, and those in the normal saline (NS) group received 400ml of NS nasal irrigation daily for 2 months. Before FESS as well as before and after nasal irrigation, sino-nasal symptoms were assessed by a 22-item Sino-Nasal Outcome Test questionnaire and patients received endoscopic examination, nasal function tests, cytokine measurement of nasal irrigant, and bacterial culture from the middle meatus. The safety of nasal irrigation was assessed by self-reported adverse events, blood test, Eustachian Tube Dysfunction Patient Questionnaire and Eustachian tube function test. This study tried to evaluate the efficacy and safety of xylitol nasal irrigation as an adjuvant therapy after FESS, particularly the influence of nasal irrigation on Eustachian tube function.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| xylitol | Experimental | Drug: Xylitol PowderIn the xylitol group, 5% xylitol solutions were first prepared by mixing two packs of 10 mg xylitol powder with 400 mL of sterile water in the container of the irrigator. Nasal irrigation was performed by using a Sanvic SH903 pulsatile irrigator (Yun-Wang Industrial Co., Tainan, Taiwan). When irrigating the nose, patients irrigated both of their nasal cavities each with 200 mL of solutions once a day. Patients performed nasal irrigations for 2 months. |
| saline | Placebo comparator | Drug: Salt PowderIn the saline group, the normal saline solution was prepared by mixing 2 packs of 1.8 mg salt powder with 400 mL of sterile water in the container of the irrigator. Nasal irrigation was performed by using a Sanvic SH903 pulsatile irrigator (Yun-Wang Industrial Co., Tainan, Taiwan). When irrigating the nose, patients irrigated both of their nasal cavities each with 200 mL of solutions once a day. Patients performed nasal irrigations for 2 months. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with chronic rhinosinusitis who failed medical treatment
- Patients underwent bilateral primary functional endoscopic sinus surgery.
Key exclusion criteria (5 listed)
- Patients with a history of immunodeficiency
- Patients with a history of sinus surgery
- Patients who receiving antibiotic treatment within a week before functional endoscopic sinus surgery
- Patients with a pathological diagnosis of fungal sinusitis
- Patients with a pathological diagnosis of sinonasal tumor
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 |
|---|---|---|
| Xylitol PowderThe bilateral nasal cavity was irrigated by using a Sanvic SH903 pulsatile irrigator containing 400 ml of xylitol solution once a day for 2 months. | Drug | xylitol |
| Salt PowderThe bilateral nasal cavity was irrigated by using a Sanvic SH903 pulsatile irrigator containing 400 ml of normal saline once a day for 2 months. | Drug | saline |
Primary outcome
Taiwanese version of the 22-item Sino-Nasal Outcome Test
Time frame: From before operation to 3 months after surgery
The Taiwanese version of the 22-item Sino-Nasal Outcome Test contains 22 items of symptoms and social/emotional consequences from nasal disorder. Patients are asked to rate their problems based on how they have been over the past two weeks. Each item is graded from 0 (no problem) to 5 (as bad as it can be) according to its severity and frequency.
Self-reported adverse events
Time frame: From before nasal irrigation to after 2-month nasal irrigation
Any adverse events occurring during the 2 months period of nasal irrigation
5 secondary outcomes
Change of the second minimal cross-sectional area of the nasal cavity
Time frame: From before operation to 3 months after surgery
Change of endoscopic score
Time frame: From before operation to 3 months after surgery
Change of saccharine transit time
Time frame: From before operation to 3 months after surgery
Change of score measured by Eustachian Tube Dysfunction Patient Questionnaire
Time frame: From before nasal irrigation to after 2-month nasal irrigation
Change of Eustachian Tube function by the nine-step inflation/deflation test
Time frame: From before nasal irrigation to after 2-month nasal irrigation
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 31 Oct 2023.
- Individual participant dataSharing planned: Yes. Outcome measures
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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.
Rong-San Jiang, MD, PhD principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xylitol Powder and Salt Powder in people with Chronic Rhinosinusitis and Postoperative Care, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 2 inclusion and 5 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 31 Oct 2023. 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 Taiwan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Taiwanese version of the 22-item Sino-Nasal Outcome Test (time frame: From before operation to 3 months after surgery). The study lists 2 primary outcomes in all. 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 31 Oct 2023.