ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000319976

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 post operative sinus surgery patients

Scientific title

Determining residence time and side effects of thermoresponsive, mucoadhesive solgels in post endoscopic sinus surgery cavities

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1248-3780

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

The study involves the application of a solgel containing dexamethasone to previously opened sinus cavities. The solgel will be prepared at the Princess Alexandra Hospital in the Pharmacy department using techniques described by Pandey et al with blue food dye added to aid contrast between mucosal tissue.

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

Participants will be recruited from Greenslopes Private hospital from the two supervising Otolaryngology Head and Neck (OHN) surgeons outpatients. They will be eligible if they are at least 6 weeks or more post endoscopic sinus surgery and had at least either their maxillary or ethmoid sinuses opened surgically. They will be approached at their postoperative follow up appointment by the treating consultant. If they are interested in participating in the trial will be contacted by the primary investigator to discuss the trial and obtain consent.

The trial will be conducted at the Princess Alexandra Hospital in the OHN surgery outpatient department. Each participant will receive three actuations (100 micrograms/actuation) of Co-phenylcaine nasal spray (ENT Technologies, Melbourne) to each nostril to anaesthetise and decongest the nasal cavity prior to solgel administration. Under direct vision using a rigid endoscope (Storz), solgel will be applied to the surgically opened sinus cavities of the maxilla and/or ethmoid and/or sphenoid sinus using a syringe device. A photo will be taken before and after the solgel application. All images taken throughout will be saved onto the Karl Storz system as a study number and transferred to an encrypted USB.

The maxillary sinus and/or sphenoid cavity will have 2 ml of solgel applied to the posterior wall while the ethmoid cavity will have 1ml applied. The cavities will be assessed again in 5 minutes with the rigid endoscope to assess the distribution. The patient will then be reviewed the following day and have their sinuses re-examined to assess for remaining gel. If the gel is still present, they will be reviewed again at day 5 to assess for the presence of the solgel.

Patients with diseased sinuses will have their sinuses graded independently by a sinus surgeon using the Modified Lund Mackay postoperative endoscopy score if they are assessed at the day 5 visit to assess for any improvement.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

To determine the length of time the solgel remains within a postoperative sinus cavity

Timepoint [1]

5 minutes post application of solgel; day 1 post application of solgel; day 5 post application of solgel assessed under direct vision using a rigid endoscope (Storz)

Primary outcome [2]

Interval improvement in appearance of sinus mucosa

Timepoint [2]

Patients with diseased sinuses will have their sinuses graded independently by a sinus surgeon using the Modified Lund Mackay postoperative endoscopy score if they are assessed at the day 5 visit to assess for any improvement.

Secondary outcome [1]

To establish the side effect profile of the solgel

Timepoint [1]

Patients will be assessed and screened for side-effects and have the opportunity to report these during the initial administration, clinic follow up and via correspondence in the week following the trial. Potential side effects include headaches, nasal irritation and nose bleeds.

Eligibility

Key inclusion criteria

i. Above 18 years of age
ii. Currently fit and healthy
iii. Available for required follow up
iv. Previous endoscopic sinus surgery >6 weeks ago

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Allergies to any of the medications being used in the trial

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

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

6/04/2020

Actual

Date of last participant enrolment

Anticipated

30/11/2020

Actual

Date of last data collection

Anticipated

28/12/2020

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
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
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]

22/09/2019

Approval date [1]

26/09/2019

Ethics approval number [1]

HREC/17/QPAH/730

Summary

Brief summary

Chronic rhinosinusitis (CRS) is a heterogeneous, multifactorial disease defined by sinonasal inflammation persisting more than 12 weeks. According to the Australian National Health Survey, in 2007-2008, 9.2% of the Australian population suffer from CRS. Along with sinonasal symptoms, patients frequently suffer with low mood, poor sleep and fatigue leading to significant direct and indirect costs to the health system. Despite the prevalence of the condition in the community and the burden both physically and financially, there is an ongoing search for an efficient and practical method to deliver ongoing treatment. 

The recent International Consensus Statement on the treatment of CRS include nasal saline irrigation and intranasal corticosteroid sprays/drops with the addition of a short course of oral corticosteroids for the CRS with nasal polyps (CRSwNP) subgroup. Topical therapy offers the benefits of high local concentrations without the systemic side effects, however in unoperated sinuses, delivery to the sinus mucosa is limited and less than 2% of the irrigated volume reaches the sinuses. Endoscopic sinus surgery (ESS) is essential to allow topical treatment to effectively reach the sinus cavities and is the treatment of choice in patients who fail to respond to appropriate medical therapy (AMT). The intention of ESS is to restore natural sinus ventilation and drainage pathways, relieve nasal obstruction with the preservation of mucosa, and ultimately allow CRS treatment to be de-escalated from systemic to topical treatments for long-term management. 

Topical steroids are an integral component of postoperative care in ESS. There is high-level evidence supporting their use, which has been shown to significantly improve patient’s self-reported symptoms and endoscopic scores at 6 & 12 months. In the clinical setting, steroids are mixed into high volume washes for delivery. Unfortunately, these devices have short mucosal contact time and require daily use. Ideal drug preparation should be delivered in a manner to optimise mucosal contact time with steady absorption & minimal wastage. 

Mucoadhesive, thermoresponsive in situ gelling systems (solgels) pose a potential vector for drug delivery. These polymer-based gels can be formulated to rapidly transform in situ from a liquid to gel once at sinonasal temperature and slowly release a drug to the target tissue. Recently, these soluble gels have been analysed ex-vivo in human nasal tissue and demonstrated prolonged mucosal contact time and sustained release of dexamethasone. Establishing the viability of these gels in-vivo opens an innovative method for drug delivery to the sinonasal mucosa with potential to treat a broad range of sinus conditions. This aim of this trial is to assess the use of solgels as a vector to deliver steroid to surgically opened sinus cavities. Assessment of delivery to sinuses, residence time & local side effects will be the primary areas of interest.

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
6930	Study protocol	379283-(Uploaded-16-02-2020-16-04-59)-Study-related document.docx
6931	Informed consent form	379283-(Uploaded-16-02-2020-16-09-13)-Study-related document.docx
6932	Ethical approval	379283-(Uploaded-16-02-2020-16-05-47)-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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