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Trial registered on ANZCTR


Registration number
ACTRN12620000578909
Ethics application status
Approved
Date submitted
7/02/2020
Date registered
18/05/2020
Date last updated
18/05/2020
Date data sharing statement initially provided
18/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the effectiveness of steroid delivered via a nebuliser or a sinus rinse in the management of chronic rhinosinusitis.
Scientific title
Double Blinded Randomised Controlled Human Clinical Trial on the Effectiveness of Nebulised Steroid at Half the Dose in Comparison to Steroid Administered via an Intranasal Wash in Management of Patients with Chronic Rhinosinusitis.
Secondary ID [1] 300480 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic rhinosinusitis 316149 0
Condition category
Condition code
Inflammatory and Immune System 314443 314443 0 0
Other inflammatory or immune system disorders
Respiratory 314444 314444 0 0
Other respiratory disorders / diseases
Surgery 314445 314445 0 0
Other surgery
Infection 314446 314446 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with symptomatic chronic rhinosinusitis who have had previous sinus surgery and have evidence of chronic rhinosinusitis on endoscopic examination will be recruited into this trial.

Patients will be blindly, randomly selected into one of two treatment groups. Treatment group 1 (number = 27) will have daily sinus nebulisation of 0.5 mg of Budesonide using the nebuliser P&S T45 TEKCELEO patented MICRONICE™ device and twice daily sterile saline intranasal wash for a period of 6 weeks. Apart from the first nebulisation, all nebulisation and intranasal washes will be performed at home.

Patients will complete symptom questionnaires and have endoscopic nasal examinations in the Ear, Nose and Throat (ENT) outpatient clinic prior to and on completion of the trial. Please note that endoscopic nasal examinations are routinely performed as part of normal assessment in the ENT outpatient clinic. Adverse side events and concomitant medications are also checked at each appointment.

At the end of the trial the patients must return the nebuliser kit and any unused trial medication provided as part of the research trial.
Intervention code [1] 316778 0
Treatment: Devices
Comparator / control treatment
Patients blindly, randomly selected into treatment group 2 (number = 27) will have standard of care treatment of twice daily sterile saline intranasal wash (with one of these washes containing Budesonide 1 mg / 2 ml mixed in with the saline solution) for a period of 6 weeks. Plus, concurrent daily sinus nebulisation of saline solution using the nebuliser P&S T45 TEKCELEO patented MICRONICE™ device for a period of 6 weeks. Apart from the first nebulisation, all nebulisation and intranasal washes will be performed at home.

Patients will complete symptom questionnaires and have endoscopic nasal examinations in the Ear, Nose and Throat (ENT) outpatient clinic prior to and on completion of the trial. Please note that endoscopic nasal examinations are routinely performed as part of normal assessment in the ENT outpatient clinic. Adverse side events and concomitant medications are also checked at each appointment.

At the end of the trial the patients must return the nebuliser kit and any unused trial medication provided as part of the research trial.
Control group
Active

Outcomes
Primary outcome [1] 322785 0
Change in Lund-Kennedy Endoscopic Score (LKS).

This validated method will be used to assess the endoscopic appearance of the sinus using 5 characteristics, graded 0-2 for each side. Total score out of 20.
Timepoint [1] 322785 0
1. Day 1 of the trial prior to start of trial medication
2. Day 43 (+/- 3 days) following completion of trial medication
Primary outcome [2] 322786 0
Change in patient reported symptoms using the Sino-nasal Outcome Test 22 (SNOT-22).

This validated patient questionnaire is consists of 22 questions regarding symptoms/quality of life, each graded 0-5.
Timepoint [2] 322786 0
1. Day 1 of the trial prior to start of trial medication
2. Day 43 (+/- 3 days) following completion of trial medication
Primary outcome [3] 322787 0
Change in patient reported symptoms using the Visual Analogue Scale (VAS).

This validated patient questionnaire requires patients to score 7 symptoms on a scale of 0-10.
Timepoint [3] 322787 0
1. Day 1 of the trial prior to start of trial medication
2. Day 43 (+/- 3 days) following completion of trial medication
Secondary outcome [1] 379769 0
Preliminary assessment of tolerability of intervention by patient reporting of discomforts or adverse events. For example, minor nose trauma or bleed, or sensation of blocked ears.
Timepoint [1] 379769 0
1. Day 1 of the trial following first nebulisation
2. Day 43 (+/- 3 days) following completion of trial medication

Eligibility
Key inclusion criteria
- Participants must have had at least two of the following symptoms of chronic rhinosinusitis (nasal discharge, postnasal drip, nasal obstruction, facial pain and pressure or lack of sense of smell) that has been previously persistent for greater than 3 months.
- Participants must have had at least one operation for their chronic rhinosinusitis but should be at least 6 weeks post-operative.
- Participants must show evidence of chronic rhinosinusitis by direct endoscopic examination.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Age under 18
- Participants unable to give informed written consent
- Participants unable to comply with study protocol

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 concealed. Randomisation and allocation will be performed by The Queen Elizabeth Hospital. Participants will be given the nebuliser device, unmarked nebuliser solution and unmarked solution to add to their intranasal saline wash.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Research Randomiser to perform randomisation into permuted blocks 27 – randomised to either nebulised steroid or intranasal steroid wash (active control group).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Not applicable.
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Our study outcomes are numeric values. A partially blinded (arms defined but treatment not revealed) statistical analysis will be carried out; non-parametric tests such as Mann-Whitney U Test to compare the means of each group at each time point. A difference between the two arms of P<0.05 would be considered statistically significant. After data analysis is complete, the treatment arms would be revealed to assess if intervention was more effective than standard of care.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/05/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
54
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 15816 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 29252 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 304901 0
Hospital
Name [1] 304901 0
The Queen Elizabeth Hospital, Department of Otolaryngology, Head and Neck Surgery
Country [1] 304901 0
Australia
Primary sponsor type
Individual
Name
Professor Peter-John Wormald
Address
Department of Otolaryngology, Head and Neck Surgery
The Queen Elizabeth Hospital
Tower Block 3C, 28 Woodville Road
Woodville South SA 5011
Country
Australia
Secondary sponsor category [1] 305242 0
None
Name [1] 305242 0
Address [1] 305242 0
Country [1] 305242 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305310 0
Central Adelaide Local Health Network Human Research Ethics Committee (CALHN HREC)
Ethics committee address [1] 305310 0
Royal Adelaide Hospital
Clinical Trial Centre
Wayfinder 3D460.02
Level 3
Port Road
ADELAIDE SA 5000
Ethics committee country [1] 305310 0
Australia
Date submitted for ethics approval [1] 305310 0
28/10/2019
Approval date [1] 305310 0
22/01/2020
Ethics approval number [1] 305310 0
12300

Summary
Brief summary
Investigator initiated, single-centre, medical device, double blinded, randomised control trial to evaluate the safety, tolerability and effectiveness of topical Budesonide administered via a nebuliser at half the dose compared to Budesonide administered within a sterile saline intranasal wash in the management of chronic rhinosinusitis (CRS).

A total of 54 participants will be enrolled in the study, which will allow for 27 participants in each treatment arm. Participants with symptomatic CRS who have had at least one prior sinus operation will be recruited from the Ears, Nose and Throat (ENT) Outpatient Clinic at The Queen Elizabeth Hospital. They will be randomly allocated to one of two treatment arms: either they will have daily nebulised steroid (0.5 mg Budesonide) and twice daily saline intranasal rinses for 6 weeks or, daily nebulised saline and twice daily saline rinses (one of which has 1 mg of Budesonide added) for 6 weeks.

Patients will be given a 2 ml ampoule of colourless solution to add to their nebuliser solution and a 2 ml ampoule of colourless solution to add to one of their daily sinus rinses. Both of these ampoules will be over-labelled to disguise their contents (either Budesonide or sterile water depending on which arm they are recruited). Patient concurrent medication data, adverse events, symptom scores and endoscopic scores will be collected prior to initiation of trial and at the 6 week mark on completion of trial.

We hypothesis that when administered via nebuliser P&S T45 TEKCELEO patented MICRONICE™ device, Budesonide will be able to be delivered to a larger surface area of sinonasal mucosa and hence be at least as, or more, effective at half the dose than when administered within an intranasal rinse. A nebulisation device will also allow patients an alternative option for self-administering topical Budesonide and decrease medication wastage.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99946 0
Prof Peter-John Wormald
Address 99946 0
Department of Otolaryngology, Head and Neck Surgery
The Queen Elizabeth Hospital
Tower Block 3C
28 Woodville Road
Woodville South SA 5011
Country 99946 0
Australia
Phone 99946 0
+61 8 8222 6782
Fax 99946 0
Email 99946 0
[email protected]
Contact person for public queries
Name 99947 0
Anna Megow
Address 99947 0
Department of Otolaryngology, Head and Neck Surgery
The Queen Elizabeth Hospital
Tower Block 3C
28 Woodville Road
Woodville South SA 5011
Country 99947 0
Australia
Phone 99947 0
+61 412394002
Fax 99947 0
Email 99947 0
[email protected]
Contact person for scientific queries
Name 99948 0
Anna Megow
Address 99948 0
Department of Otolaryngology, Head and Neck Surgery
The Queen Elizabeth Hospital
Tower Block 3C
28 Woodville Road
Woodville South SA 5011
Country 99948 0
Australia
Phone 99948 0
+61 412394002
Fax 99948 0
Email 99948 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We will publish the results of the trial in a suitable scientific journal. This will not include individual participant data, summary tables and statistical analysis only.


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.