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Trial registered on ANZCTR


Registration number
ACTRN12620000318987
Ethics application status
Approved
Date submitted
16/02/2020
Date registered
9/03/2020
Date last updated
9/03/2020
Date data sharing statement initially provided
9/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Nasal solgel therapy performance in healthy volunteers
Scientific title
The in vivo performance of mucoadhesive, thermoresponsive soluble gels in healthy, adult nasal mucosa
Secondary ID [1] 300523 0
nil known
Universal Trial Number (UTN)
U1111-1248-1087
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic rhinosinusitis 316218 0
Condition category
Condition code
Inflammatory and Immune System 314509 314509 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Solgel applied to the nasal cavity mucosa to ascertain its mucoadhesive capabilities.

Solgel consists of:
- Poloxamer 407 16% w/w
- Glycerin 3% w/w
- Propylparaben 0.03% w/w
- Polyvinyl alcohol 0.03% w/w
- Polycarbophil 0.02% w/w
- Dexamethasone 21-phosphate sodium salt 0.1% w/w
- water soluble blue dye

All participants will be provided with a participant information sheet describing the purpose, goals and methods of the trial.

The trial will be conducted in the otolaryngology head and neck surgery (OHNS) outpatient clinic at the Princess Alexandra Hospital by both consultant and registrar OHNS surgeons.

All participants will lie at 30 degrees on a bed and receive two actuations (100 micrograms/actuation) of Co-phenycaine nasal spray (ENT Technologies, Melbourne) to each nostril to anaesthetise and decongest the nasal cavity prior to administration of solgel. A flexible video rhinolaryngoscope (Olympus) attached to a high-definition camera system (Storz) will be used to visualise 0.5ml of solgel applied to the lateral nasal wall and middle turbinate. This will be applied to one side of the nasal cavity only. Solgel will be applied manually using syringe + 14G metal suction tip procured from MEDIPLAST Malmö, Sweden.

The first component of the trial assesses the reversibility of the solgel. Three participants will have gel applied as above. After five minutes, to ensure gelation of the solgel has occurred, they will rinse the nasal cavity with 200mls of sterile saline water at room temperature using a nasal douching bottle. A nasendoscope will be reinserted to assess the adequacy of the washout with photo documentation. If required, repeated washouts will be undertaken until the gels are unable to be visualised and a recording of the number of washes required will be noted.

The second stage involves assessing the duration and potential side effects of the gel. Each participant will have solgel applied in liquid form to their nasal cavity. A photo will be taken immediately following the gels application and again at 2-4 hours and 6-8 hours post application on day 1. Photos will again be taken on days 2 and 5. At this stage, if the participant remains healthy and unaffected by the drug they will be reviewed again on day 8 and 12. At each review we will assess the presence of remaining gel and examine for any evidence of mucosal irritation or erosion. If the gel remains visible at day 12, the participant will rinse out the remaining gel with room temperature sterile saline water using a nasal douching bottle. Participants from stage 1 will not be involved in stage 2. Stage 2 will begin on the same day as stage 1.

During the examination, once the gel is deemed to no longer be visible, participants will fill out a questionnaire assessing nasal symptoms associated with the gel including: nasal obstruction, irritation or burning, bleeding, post nasal drip, rhinorrhoea, smell and taste.

All images taken throughout will be saved onto the Karl Storz system as a study number and transferred to an encrypted USB. Participants will be asked to avoid rinsing their nose with water and avoid forceful blowing of the nose during the treatment. They will be given details to register any side effects during or after the trial.
Intervention code [1] 316839 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322855 0
To determine if and how long the solgel remains on the nasal mucosa in vivo
Timepoint [1] 322855 0
5 minutes post application. Measured using a flexible video rhinolaryngoscope (Olympus) attached to a high-definition camera system (Storz)
Primary outcome [2] 323083 0
To determine whether the solgel is readily removed with cold saline washes
Timepoint [2] 323083 0
5 minutes post application. Measured using a flexible video rhinolaryngoscope (Olympus) attached to a high-definition camera system (Storz)
Secondary outcome [1] 380034 0
Potential local side effects of the gels including: nasal obstruction, irritation, burning, taste or smell and postnasal drip or rhinorrhoea. This will be assessed using a study-specific questionnaire
Timepoint [1] 380034 0
2-4 hours; 6-8 hours; day 2; day 5; day 8 and day 12 post application. Measured using a flexible video rhinolaryngoscope (Olympus) attached to a high-definition camera system (Storz). At each review we will assess the presence of remaining gel and examine for any evidence of mucosal irritation or erosion. If the gel remains visible at day 12, the participant will rinse out the remaining gel with room temperature sterile saline water using a nasal douching bottle.

Eligibility
Key inclusion criteria
i. Aged between 18-50
ii. Currently fit and healthy
iii. Available for required follow up
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
i. Sinonasal disease requiring intranasal or systemic medications
ii. Require more than one tissue per day to blow the nose
iii. Daily use of any steroid medication
iv. Allergies to any of the medications being used: dexamethasone, lignocaine or phenylephrine

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Pilot study to determine the retention of solgel in nasal cavity + side effect profile of the gel. No statistical analysis required.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15872 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 29324 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 304934 0
University
Name [1] 304934 0
University of Queensland - School of Pharmacy
Address [1] 304934 0
20 Cornwall St, Woolloongabba QLD 4102
Country [1] 304934 0
Australia
Funding source category [2] 304948 0
Hospital
Name [2] 304948 0
Princess Alexandra Hospital
Address [2] 304948 0
199 Ipswich Road
Woolloongabba
QLD 4102
Country [2] 304948 0
Australia
Primary sponsor type
Individual
Name
Angelica Lynch
Address
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102
Country
Australia
Secondary sponsor category [1] 305302 0
Individual
Name [1] 305302 0
Ben Panizza
Address [1] 305302 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102
Country [1] 305302 0
Australia
Secondary sponsor category [2] 305303 0
Individual
Name [2] 305303 0
Ben Wallwork
Address [2] 305303 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102
Country [2] 305303 0
Australia
Secondary sponsor category [3] 305304 0
Individual
Name [3] 305304 0
Peter Cabot
Address [3] 305304 0
Pharmacy Australia Centre of Excellence
University of Queensland
20 Cornwall St, Woolloongabba QLD 4102
Country [3] 305304 0
Australia
Secondary sponsor category [4] 305305 0
Individual
Name [4] 305305 0
Harendra Parekh
Address [4] 305305 0
Pharmacy Australia Centre of Excellence
University of Queensland
20 Cornwall St, Woolloongabba QLD 4102
Country [4] 305305 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305343 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 305343 0
Metro South Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 305343 0
Australia
Date submitted for ethics approval [1] 305343 0
Approval date [1] 305343 0
21/08/2019
Ethics approval number [1] 305343 0
HREC/17/QPAH/120

Summary
Brief summary

Chronic rhinosinusitis (CRS) is a common condition in which the cavities around nasal passages (sinuses) become inflamed and swollen for at least 12 weeks, despite treatment attempts. This then causes mucous build up.

According to the Australian National Health Survey, in 2007-2008, 9.2% of the Australian population reported to suffer from this condition. Symptoms include difficulty breathing through the nose, the area around the eyes and face may feel swollen and the patient may have facial pain or tenderness. Patients also frequently suffer from depression, poor sleep and fatigue leading to significant direct and indirect costs to the health system. Even though this condition is common in the community, there is an ongoing search for an efficient and practical method to deliver ongoing treatment that decreases the financial and physical burdens of CRS.

The most recent accepted standard treatment of CRS include nasal saline irrigation (washing the nasal passages with a mild salt water solution) and intranasal corticosteroid sprays/drops (applying medicine directly into the nose through drops or spray). Corticosteroids are medicines that assist in treating inflammation in the body. Current practice of adding a corticosteroid to the saline wash solution means the medication does not stay in the nose for very long and this then requires daily treatment.

Applying the corticosteroid directly to the inside of the nose (nasal mucosa) offers the benefits of treating CRS directly with high local concentrations without the systemic (whole body) side effects. There has been recent interest in the use of soluble gels, that gradually dissolve, which are applied directly to the inside of the nose to deliver these medicines. These soluble gels slowly release the medication into the surrounding tissue.

These gels have the potential to change the way medications are delivered to the nasal mucosa and thus the treatment of CRS.


The aims of this trial is to ascertain:
1. how long the soluble gel takes to dissolve once applied to the nasal mucosa
2. if the addition of a corticosteroid medication to the soluble gel affects the time it takes to dissolve.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100066 0
Dr Angelica Lynch
Address 100066 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102
Country 100066 0
Australia
Phone 100066 0
+61 7 31762111
Fax 100066 0
Email 100066 0
angelicalynch945@gmail.com
Contact person for public queries
Name 100067 0
Dr Angelica Lynch
Address 100067 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102
Country 100067 0
Australia
Phone 100067 0
+61 7 31762111
Fax 100067 0
Email 100067 0
angelicalynch945@gmail.com
Contact person for scientific queries
Name 100068 0
Dr Angelica Lynch
Address 100068 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102
Country 100068 0
Australia
Phone 100068 0
+61 7 31762111
Fax 100068 0
Email 100068 0
angelicalynch945@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
confidentiality
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 6884 0
Study protocol
Citation [1] 6884 0
Link [1] 6884 0
Email [1] 6884 0
Other [1] 6884 0
Type [2] 6885 0
Informed consent form
Citation [2] 6885 0
Link [2] 6885 0
Email [2] 6885 0
Other [2] 6885 0
Type [3] 6886 0
Ethical approval
Citation [3] 6886 0
Link [3] 6886 0
Email [3] 6886 0
Other [3] 6886 0
Summary results
No Results