Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000007639p
Ethics application status
Submitted, not yet approved
Date submitted
17/11/2022
Date registered
9/01/2023
Date last updated
9/01/2023
Date data sharing statement initially provided
9/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A novel approach for delivery of nasal topical corticosteroid sprays in post-surgery chronic rhinosinusitis
Scientific title
Comparing dispersion of fluticasone using a novel device to a standard nasal spray in post-surgery chronic rhinosinusitis
Secondary ID [1] 308435 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-surgery chronic rhinosinusitis 328233 0
Functional endoscopic sinus surgery 328437 0
Condition category
Condition code
Respiratory 325284 325284 0 0
Other respiratory disorders / diseases
Surgery 325463 325463 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Crossover trial comparing dispersion of fluticasone between novel nasal adaptor and a standard nasal spray.

Methods:
An experienced ENT surgeon will perform the endoscopic procedures for the placement and removal of filter paper from the sinuses at an ENT clinic. The total duration of the testing session will take approximately 45 minutes.
To measure the dispersion achieved by the novel nasal adaptor, filter paper circles of diameter 5 mm will be placed into the sinonasal cavities of 15 recovered post-surgery chronic rhinosinusitis patients under endoscopic guidance (frontal recess, posterior wall of maxillary sinus and front face of sphenoid inferior to the sphenoidotomy). Fluticasone (125 ug) will be administered through a metered dose inhaler with the novel adapter attached. The angle of the administration into the anterior nares will be delivered and carefully controlled by the investigators. This procedure will take approximately 15 minutes.
After administration, the filter paper circles will be retrieved. Patients will then be asked to perform a saline lavage and new filter dots will be placed in the same sinonasal locations. This part will take approximately 15 minutes.
The same procedure will be repeated with a standard spray (more details are provided in the control treatment field). This part of the testing will take approximately 15 minutes.
Intervention code [1] 324882 0
Treatment: Devices
Comparator / control treatment
Metered device inhaler with a novel adapter will be compared with a standard nasal spray.

The order in which the devices will be tested will be randomised.

To measure the dispersion achieved by the standard spray, filter paper circles of diameter 5 mm will be placed into the sinonasal cavities as described above. The standard nasal spray contains 25 ug of fluticasone per puff. To provide similar fluticasone doses between the novel device and standard spray, three puffs (3x 25 ug) will be required. The angle of the administration into the anterior nares will be delivered and carefully controlled by the investigators. After administration, the filter paper circles will be retrieved.
This procedure will take approximately 15 minutes.
Control group
Active

Outcomes
Primary outcome [1] 333147 0
Dispersion of fluticasone assessed using high-performance liquid chromatography performed on intranasal filter papers
Timepoint [1] 333147 0
5 minutes after intervention
Primary outcome [2] 333311 0
An adjusted Meltzer Clinical Trial Patient Preference Questionnaire (CTPPQ) will be used to access satisfaction of the devices
Timepoint [2] 333311 0
10 minutes after intervention
Primary outcome [3] 333453 0
An adjusted Meltzer Clinical Trial Patient Preference Questionnaire (CTPPQ) will be used to access preference of the devices.
Timepoint [3] 333453 0
10 minutes after intervention
Secondary outcome [1] 415943 0
Primary outcome: An adjusted Meltzer Clinical Trial Patient Preference Questionnaire (CTPPQ) will be used to access compliance of the devices
Timepoint [1] 415943 0
10 minutes after intervention

Eligibility
Key inclusion criteria
Patients meeting the criteria of the 2020 European Position Paper (EPOS) definition of CRS patients with and without polyposis.
CRS patients that have undergone FESS
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current malignant or significant cardiovascular disease
- Current smokers, i.e. those who had smoked within the last 12 months.
- Diabetes treated with insulin or other prescribed medications
- History of kidney disease as an adult, including renal tumour or transplant
- History of chronic lung diseases
- History of recurrent lung infections
- History of severe hepatic disease/liver transplant/pending liver transplant.
- History of severe or multiple allergies, including hay-fever and perennial rhinitis
- Hypertension (high blood pressure) requiring medication
- Multiple myeloma
- Participants with documented or suspected, clinically significant alcohol or drug abuse
- Pregnant
- Significant upper and/or lower respiratory tract infection within the previous 4 weeks
- Solid organ transplant

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Drug levels from the filter papers will be measured using HPLC and statistically analysed using R software. Comparisons will be made between devices and between the three sinus sites.

An adjusted Meltzer Clinical Trial Patient Preference Questionnaire (CTPPQ) will be used to access satisfaction, preference and compliance of the devices. Annova tests will be conducted to analyze between groups using GraphPad Prism (version 6).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2023
Actual
Date of last participant enrolment
Anticipated
31/10/2023
Actual
Date of last data collection
Anticipated
30/11/2023
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 25147 0
New Zealand
State/province [1] 25147 0
Auckland

Funding & Sponsors
Funding source category [1] 312683 0
University
Name [1] 312683 0
University of Auckland
Country [1] 312683 0
New Zealand
Funding source category [2] 312822 0
Charities/Societies/Foundations
Name [2] 312822 0
Passe and Williams Foundation
Country [2] 312822 0
Australia
Primary sponsor type
University
Name
University of Auckland
Address
22-30 Park Avenue, Grafton
Department of Surgery,
School of Medicine,
The University of Auckland.
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 314294 0
Hospital
Name [1] 314294 0
Auckland City Hospital
Address [1] 314294 0
2 Park Road,
Grafton,
Auckland 1023
Country [1] 314294 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311985 0
: HDEC Extra Meeting Subcommittee
Ethics committee address [1] 311985 0
Health and Disability Ethics Committees,
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 311985 0
New Zealand
Date submitted for ethics approval [1] 311985 0
18/11/2022
Approval date [1] 311985 0
Ethics approval number [1] 311985 0

Summary
Brief summary
Chronic rhinosinusitis (CRS) is a condition characterised by inflammation of the sinonasal mucosa which lasts for more than three months. Symptoms include nasal discharge, sneezing and nasal congestion. CRS is common in the general population, having a prevalence of 5-10%. A key treatment for this condition is intranasal topical corticosteroid sprays such as fluticasone, which act to reduce sinonasal inflammation. However, at this point in time nasal drug delivery in patients with CRS is suboptimal. Patients continue to use these sprays daily even after they have had surgery.

Currently, the handful of studies that describe the therapeutic efficacy of these medications have shown inconsistent results. One possible explanation for this is the limitation of the drug distribution within the sinonasal cavity.

Prior research has been conducted from our group in collaboration with Auckland Bioengineering Institute to design a novel nasal adaptor that fits onto a standard metered dose (MDI) asthma inhaler, which aims to improve the dispersion of medication into the nasal cavity. Additionally, unlike the standard nasal sprays, the MDI does not require patients to lean forward during administration, nor is there an associated taste or post-nasal drip of spray. It is possible that these factors will improve patient compliance, leading to greater therapeutic efficacy.
The aim of this study is to conduct a crossover trial of the novel device with a standard nasal spray in post-surgery CRS patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123066 0
Prof Richard Douglas
Address 123066 0
Department of Surgery
The University of Auckland
Private Bag 92019
Auckland Mail Centre 1142
Country 123066 0
New Zealand
Phone 123066 0
+64 272186083
Fax 123066 0
Email 123066 0
[email protected]
Contact person for public queries
Name 123067 0
Kristi Biswas
Address 123067 0
Department of Surgery
The University of Auckland
Private Bag 92019
Auckland Mail Centre 1142
Country 123067 0
New Zealand
Phone 123067 0
+642102677190
Fax 123067 0
Email 123067 0
[email protected]
Contact person for scientific queries
Name 123068 0
Kristi Biswas
Address 123068 0
Department of Surgery
The University of Auckland
Private Bag 92019
Auckland Mail Centre 1142
Country 123068 0
New Zealand
Phone 123068 0
+642102677190
Fax 123068 0
Email 123068 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?
Individual participant data collected after de-identification underlying published results only will be made available.
When will data be available (start and end dates)?
June 2023 - Feb 2024.
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
access can be requested from the investigator Dr Kristi Biswas (email: [email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.