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Trial registered on ANZCTR


Registration number
ACTRN12621000707864p
Ethics application status
Not yet submitted
Date submitted
25/02/2021
Date registered
8/06/2021
Date last updated
8/06/2021
Date data sharing statement initially provided
8/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Nasal spray for patients with chronic rhinosinusitis undergoing (Functional Endoscopic Sinus Surgery) FESS
Scientific title
Xylitol and sodium hyaluronate nasal spray to improve postoperative healing in patients with chronic rhinosinusitis undergoing functional endoscopic sinus surgery.
Secondary ID [1] 303498 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic rhinosinusitis
 320822 0
Condition category
Condition code
Respiratory 318647 318647 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 319074 319074 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
51 patients will be recruited. In the immediate postoperative period, patients will have one placebo nasal spray containing normal saline 0.9% to be administered to one nasal passage and one treatment nasal spray containing the formulation with active ingredients to be administered to the other. Ingredients in the treatment spray are (Active Qty/LC per spray): Sodium Hyaluronate (SH) 0.9 mg, Xylitol 7.5, Hypromellose (HPMC 2208) 0.23 mg, Potassium Sorbate 0.15 mg, Citric Acid Anhydrous 0.18 mg, Sodium Citrate Dihydrate 0.38, Purified Water 140.67 mg.
Patients will be asked to apply 3 puffs (sprays) on each nostril 2 times a day for 60 days. The spray will be self-administered by the patient. Administration of the spray will initiate in the immediate postoperative period (the night of the day of surgery). 3 postoperative follow-ups will be made. Follow up will be conducted at 7 days, 28 days and 60 days post-operatively. These are the usual post- operative follow up times which are based on early average mucosal healing duration. These follow up times ensure that patients do not need to attend clinic more often than standard practice.
Several strategies will me used to monitor adherence to intervention including: self-report diary by the patient, the patients will be asked to bring spray bottles to clinic to confirm if content has been used. If present at clinic, family members will be asked if they have observed correct usage of the nasal spray.
Subjective symptoms such as rhinorrhea, nasal obstruction, dryness, bleeding, and crust formation will be analysed individually with a numerical rating scale.
Postoperative changes will be analysed with a validated endoscopic score.
Intervention code [1] 319785 0
Treatment: Other
Comparator / control treatment
Saline solution 0.9%.
Patients will be asked to apply 3 puffs (sprays) on one nostril 2 times a day for 60 days.
The patient will self-administer the nasal spray starting on the same day of the surgical procedure.
Several strategies will me used to monitor adherence to intervention including: self-report diary by the patient, the patients will be asked to bring spray bottles to clinic to confirm if content has been used. If present at clinic, family members will be asked if they have observed correct usage of the nasal spray.
Control group
Placebo

Outcomes
Primary outcome [1] 326595 0
Differences in mucosal healing as measured by subjective symptom scores using a study-specific questionnaire composed of a series of numeric rating scales assessing postoperative symptoms ranging from 1 (absent) to 5 (very severe) assessing postoperative nasal symptoms such as nasal discharge, nasal obstruction, dryness, bleeding and crust formation.
Timepoint [1] 326595 0
7, 28, and 60 days post-operatively
Primary outcome [2] 327168 0
Objective endoscopic scores measured by Lund-Kennedy endoscopy scoring system.
Timepoint [2] 327168 0
7, 28, and 60 days post-operatively
Secondary outcome [1] 392050 0
Comfort associated with usage of nasal spray on each nostril using a series of numeric rating scales ranging from 1 (absent) to 5 (very severe) assessing discomfort associated with the use of the nasal spray containing active ingredients.
Timepoint [1] 392050 0
60 days after randomization. This secondary outcome will be assessed on the third and final visit which will be 60 days after randomization only.

Eligibility
Key inclusion criteria
-Chronic rhinosinusitis patients undergoing FESS due to CRS as defined by the 2020 European Position Paper on Rhinosinusitis and Nasal Polyps
-18 years or older
-Competent to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Patients with septal perforation
-Pre or postoperative severe septal deviation. If a septal deviation is present, it will not be easy to discern if nasal obstruction is due to a deviated septum or to another cause such as crusting or inflammation.
-Patients who have had previous FESS. Patients with recalcitrant sinus disease who need another surgery usually have a greater compromise of normal nasal physiology, reducing effectiveness of topical therapies.
-Patients with other underlying disease that affects respiratory mucosa such as cystic fibrosis, primary ciliary dyskinesia, or aspirin hypersensitivity
-Any known allergies or hypersensitivity to any of the components of the formulations.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other
Other design features
In the immediate postoperative period, patients will have one placebo nasal spray containing normal saline to be administered to one nasal passage and one treatment nasal spray containing the formulation with active ingredients to be administered to the other. An independent researcher will randomise and label the bottles to ensure that both the participants and the investigators will be blinded as to which nasal passage is receiving the treatment nasal spray. The bottles will be identical, labelled only with an identification number and “left” or “right” to inform the patient which side to apply each nasal spray.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
There are no previous clinical trials in the literature that use a similar numerical rating scale. Therefore, no medians or standard deviations can be obtained to calculate sample size. However, using the software G*power we obtain that in order to detect an effect size of Cohen’s d=0.5 with 80% power (alpha=0.05 one tailed) we would need 51 participants in a paired samples t-test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2021
Actual
Date of last participant enrolment
Anticipated
17/12/2021
Actual
Date of last data collection
Anticipated
1/03/2022
Actual
Sample size
Target
51
Accrual to date
Final
Recruitment outside Australia
Country [1] 23477 0
New Zealand
State/province [1] 23477 0
Auckland

Funding & Sponsors
Funding source category [1] 307916 0
Commercial sector/Industry
Name [1] 307916 0
Douglas pharmaceuticals
Country [1] 307916 0
New Zealand
Primary sponsor type
Individual
Name
Richard Douglas
Address
University of Auckland
Department of Surgery
Level 2
Building 507
Park Avenue, Grafton, Auckland
Country
New Zealand
Secondary sponsor category [1] 308636 0
None
Name [1] 308636 0
Address [1] 308636 0
Country [1] 308636 0
Other collaborator category [1] 281657 0
Individual
Name [1] 281657 0
Alejandro Fandino
Address [1] 281657 0
University of Auckland
Department of Surgery
Level 2
Building 507
Park Avenue, Grafton, Auckland
Country [1] 281657 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 307914 0
Health and Disability Ethics Committees
Ethics committee address [1] 307914 0
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 307914 0
New Zealand
Date submitted for ethics approval [1] 307914 0
01/07/2021
Approval date [1] 307914 0
Ethics approval number [1] 307914 0

Summary
Brief summary
in the immediate postoperative period (same night of the surgical procedure) 51 patients will be asked to use a formulation containing Hypomellose (HPMC), Xylitol, and Hyaluronic Acid (HA) as active ingredients in one nostril and a placebo spray containing 0.9% saline solution on the other. An independent researcher will randomise and label the bottles to ensure that both the participants and the investigators will be blinded as to which nasal passage is receiving the treatment nasal spray. The bottles will be identical, labelled only with an identification number and “left” or “right” to inform the patient which side to apply each nasal spray. The patient will be instructed to carry out nasal rinses with normal saline using a squeeze bottle four times per day (the standard of care in the CRS patients after FESS). After each nasal rinse, the patient should apply the nasal sprays. The patient will be asked to apply 4 doses of the corresponding nasal spray to the indicated nostril.
Follow up will be conducted at 7 days, 28 days and 60 days post-operatively. Subjective symptoms such as rhinorrhea, nasal obstruction, dryness, bleeding, and crust formation will be analysed individually with a numerical rating scale ranging from 1 to 5 (1= no discomfort, 5= very severe discomfort). Three additional questions grading the patient’s experience in parameters such as discomfort with spray application, dripping and taste will be included in the questionnaire of the third and final visit.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108910 0
Prof Richard Douglas
Address 108910 0
Department o Surgery
Unversity of Auckland
School of Medicine
Level 2
Building 507
Park Avenue, Grafton, Auckland
1142
Country 108910 0
New Zealand
Phone 108910 0
+64 0272186083
Fax 108910 0
Email 108910 0
[email protected]
Contact person for public queries
Name 108911 0
Richard Douglas
Address 108911 0
Department o Surgery
Unversity of Auckland
School of Medicine
Level 2
Building 507
Park Avenue, Grafton, Auckland
1142
Country 108911 0
New Zealand
Phone 108911 0
+64 0272186083
Fax 108911 0
Email 108911 0
[email protected]
Contact person for scientific queries
Name 108912 0
Richard Douglas
Address 108912 0
Department o Surgery
Unversity of Auckland
School of Medicine
Level 2
Building 507
Park Avenue, Grafton, Auckland
1142
Country 108912 0
New Zealand
Phone 108912 0
+64 0272186083
Fax 108912 0
Email 108912 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Symptom score results and endoscopic score results
When will data be available (start and end dates)?
Immediately following publication. No end date determined.
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Meta-analyses, Review articles
How or where can data be obtained?
Access subject to approvals by Principal Investigator

[email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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