Trial Review

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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] 300561 0
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 316292 0
Condition category
Condition code
Inflammatory and Immune System 314563 314563 0 0
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] 316866 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322889 0
To determine the length of time the solgel remains within a postoperative sinus cavity
Timepoint [1] 322889 0
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] 323067 0
Interval improvement in appearance of sinus mucosa
Timepoint [2] 323067 0
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] 380658 0
To establish the side effect profile of the solgel
Timepoint [1] 380658 0
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?
No
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
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15892 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 29349 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 304979 0
University
Name [1] 304979 0
University of Queensland - School of Pharmacy
Country [1] 304979 0
Australia
Funding source category [2] 304980 0
Hospital
Name [2] 304980 0
Princess Alexandra Hospital
Country [2] 304980 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] 305337 0
Individual
Name [1] 305337 0
Ben Panizza
Address [1] 305337 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102
Country [1] 305337 0
Australia
Secondary sponsor category [2] 305338 0
Individual
Name [2] 305338 0
Ben Wallwork
Address [2] 305338 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102
Country [2] 305338 0
Australia
Secondary sponsor category [3] 305339 0
Individual
Name [3] 305339 0
Peter Cabot
Address [3] 305339 0
Pharmacy Australia Centre of Excellence
20 Cornwall St, Woolloongabba QLD 4102
Country [3] 305339 0
Australia
Secondary sponsor category [4] 305340 0
Individual
Name [4] 305340 0
Harendra Parekh
Address [4] 305340 0
Pharmacy Australia Centre of Excellence
20 Cornwall St, Woolloongabba QLD 4102
Country [4] 305340 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305383 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 305383 0
Metro South Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 305383 0
Australia
Date submitted for ethics approval [1] 305383 0
22/09/2019
Approval date [1] 305383 0
26/09/2019
Ethics approval number [1] 305383 0
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 100190 0
Dr Angelica Lynch
Address 100190 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102
Country 100190 0
Australia
Phone 100190 0
+61 7 31762111
Fax 100190 0
Email 100190 0
angelicalynch945@gmail.com
Contact person for public queries
Name 100191 0
Dr Angelica Lynch
Address 100191 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102
Country 100191 0
Australia
Phone 100191 0
+61 7 31762111
Fax 100191 0
Email 100191 0
angelicalynch945@gmail.com
Contact person for scientific queries
Name 100192 0
Dr Angelica Lynch
Address 100192 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102
Country 100192 0
Australia
Phone 100192 0
+61 7 31762111
Fax 100192 0
Email 100192 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6930Study protocol    379283-(Uploaded-16-02-2020-16-04-59)-Study-related document.docx
6931Informed consent form    379283-(Uploaded-16-02-2020-16-09-13)-Study-related document.docx
6932Ethical 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.