ANZCTR - Registration

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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]

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

Condition category

Condition code

Inflammatory and Immune System

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]

Treatment: Drugs

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

To determine if and how long the solgel remains on the nasal mucosa in vivo

Timepoint [1]

5 minutes post application. Measured using a flexible video rhinolaryngoscope (Olympus) attached to a high-definition camera system (Storz)

Primary outcome [2]

To determine whether the solgel is readily removed with cold saline washes

Timepoint [2]

5 minutes post application. Measured using a flexible video rhinolaryngoscope (Olympus) attached to a high-definition camera system (Storz)

Secondary outcome [1]

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]

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

Sex

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

9/03/2020

Actual

Date of last participant enrolment

Anticipated

30/06/2020

Actual

Date of last data collection

Anticipated

30/06/2020

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Princess Alexandra Hospital - Woolloongabba

Recruitment postcode(s) [1]

4102 - Woolloongabba

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Queensland - School of Pharmacy

Address [1]

20 Cornwall St, Woolloongabba QLD 4102

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Princess Alexandra Hospital

Address [2]

199 Ipswich Road
Woolloongabba
QLD 4102

Country [2]

Australia

Primary sponsor type

Individual

Name

Angelica Lynch

Address

Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Ben Panizza

Address [1]

Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Ben Wallwork

Address [2]

Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102

Country [2]

Australia

Secondary sponsor category [3]

Individual

Name [3]

Peter Cabot

Address [3]

Pharmacy Australia Centre of Excellence
University of Queensland
20 Cornwall St, Woolloongabba QLD 4102

Country [3]

Australia

Secondary sponsor category [4]

Individual

Name [4]

Harendra Parekh

Address [4]

Pharmacy Australia Centre of Excellence
University of Queensland
20 Cornwall St, Woolloongabba QLD 4102

Country [4]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Human Research Ethics Committee

Ethics committee address [1]

Metro South Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

21/08/2019

Ethics approval number [1]

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

Dr Angelica Lynch

Address

Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102

Country

Australia

Phone

+61 7 31762111

Fax

angelicalynch945@gmail.com

Contact person for public queries

Name

Angelica Lynch

Address

Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102

Country

Australia

Phone

+61 7 31762111

Fax

angelicalynch945@gmail.com

Contact person for scientific queries

Name

Angelica Lynch

Address

Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102

Country

Australia

Phone

+61 7 31762111

Fax

angelicalynch945@gmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

confidentiality

What supporting documents are/will be available?

Doc. No.	Type	Attachment
6884	Study protocol	379252-(Uploaded-28-02-2020-18-12-44)-Study-related document.docx
6885	Informed consent form	379252-(Uploaded-12-02-2020-20-35-34)-Study-related document.docx
6886	Ethical approval	379252-(Uploaded-12-02-2020-20-36-50)-Study-related document.pdf

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.

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