Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000142639
Ethics application status
Approved
Date submitted
3/02/2023
Date registered
10/02/2023
Date last updated
3/04/2024
Date data sharing statement initially provided
10/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
To find out how the saltiness of commonly used nasal washes affect the proteins in the nose mucus, in people with chronic rhinosinusitis with nasal polyps
Scientific title
The effects of different nasal saline irrigation solutions on the innate nasal proteome in patients with chronic rhinosinusitis with nasal polyps
Secondary ID [1] 308836 0
Nil known
Universal Trial Number (UTN)
U1111-1287-5687
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic rhinosinusitis with nasal polyps 328808 0
Condition category
Condition code
Inflammatory and Immune System 325818 325818 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are 2 intervention groups. In one group, the participants will be prescribed an isotonic NaCl nasal saline irrigation, specifically FLO Sinus Care. In the other group, the participants will be prescribed a low-Na nasal saline irrigation, specifically FLO CRS. Volunteers will be assigned to one of these two groups randomly.

Both of the nasal saline irrigation solutions will be prescribed for 14 days. Participants will be given sachets of either FLO Sinus Care powder or sachets of FLO CRS powder, depending on their assigned group. The sachets are blank so they will not know which one they are assigned to. The sachets can be used for making the solution which is then to be used in a sinus wash bottle.

For making and using the solution, the wash bottle and its parts need to be washed well first with warm soapy water and dried. Then, lukewarm pre-boiled water needs to be added into the wash bottle until the filling line. Then, sachet contents need to be added into the filled bottle. Finally, screw the cap and tube before shaking the bottle gently to ensure the powder is dissolved into the lukewarm pre-boiled water used.

While bending forward and tilting head down, the final solution is then administered into one nostril using the wash bottle cap while allowing drainage from the opposite nostril. The remaining solutions needs to be discarded and wash bottle washed and dried again.

Participants will be prescribed one sachet per day for 14 days. Verbal confirmation at end of study on day 14 will be used to access adherence to the intervention.
Intervention code [1] 325290 0
Treatment: Drugs
Comparator / control treatment
isotonic NaCl nasal saline irrigation
Control group
Active

Outcomes
Primary outcome [1] 333660 0
Change in concentration of different innate peptides present in nasal secretions, using mass spectrometry as an exploratory outcome.
Timepoint [1] 333660 0
Baseline and 14 days after intervention commencement
Secondary outcome [1] 417878 0
Nil
Timepoint [1] 417878 0
Nil

Eligibility
Key inclusion criteria
Patients diagnosed with chronic rhinosinusitis with polyps
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous history of nasal/sinus surgery other than adenoidectomy at =16 years, known head and neck malignancies or a history of previous radiotherapy to the head and neck, known MCC disorders, atypical disease, pregnant, severe septal deviation, and use of anticoagulants/aspirin or systemic steroids in the previous 4 weeks

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/02/2023
Actual
8/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
26
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 313061 0
University
Name [1] 313061 0
Flinders University
Country [1] 313061 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Adelaide Specialist Group
Address
Southern ENT & Adelaide Sinus Centre, Flinders Private Hospital, Suite 200, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 314760 0
None
Name [1] 314760 0
Nil
Address [1] 314760 0
Nil
Country [1] 314760 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312312 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 312312 0
Flinders Medical Centre, Flinders Drive, Bedford Park 5042, South Australia
Ethics committee country [1] 312312 0
Australia
Date submitted for ethics approval [1] 312312 0
Approval date [1] 312312 0
02/02/2023
Ethics approval number [1] 312312 0

Summary
Brief summary
Our nose and sinuses produce mucus which contains protective molecules. These molecules are part of our body’s first line of defence known as the innate immune system. However, sometimes when this system is disrupted, we can get diseases like chronic rhinosinusitis with nasal polyps (CRSwNP).

People with CRSwNP have their nose and sinuses irritated for more than 3 months. These patients often use nasal saline irrigation for treatment which is a solution that rinses your nose.

Previous work from our group has shown that, in healthy volunteers, using irrigation solutions with a lower salt concentration provides an increase in some of these protective molecules. We now want to see if this happens in people with CRSwNP too. Hence, we will compare effect of two different irrigation solutions (isotonic NaCl and low Na) on levels of protective molecules in nasal secretions of people with CRSwNP.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124206 0
Prof A. Simon Carney
Address 124206 0
Southern ENT & Adelaide Sinus Centre, Flinders Private Hospital, Suite 200, Bedford Park SA 5042
Country 124206 0
Australia
Phone 124206 0
+61 8 8277 0288
Fax 124206 0
Email 124206 0
simon.carney@flinders.edu.au
Contact person for public queries
Name 124207 0
Prof A. Simon Carney
Address 124207 0
Southern ENT & Adelaide Sinus Centre, Flinders Private Hospital, Suite 200, Bedford Park SA 5042
Country 124207 0
Australia
Phone 124207 0
+61 8 8277 0288
Fax 124207 0
Email 124207 0
simon.carney@flinders.edu.au
Contact person for scientific queries
Name 124208 0
Prof A. Simon Carney
Address 124208 0
Southern ENT & Adelaide Sinus Centre, Flinders Private Hospital, Suite 200, Bedford Park SA 5042
Country 124208 0
Australia
Phone 124208 0
+61 8 8277 0288
Fax 124208 0
Email 124208 0
simon.carney@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.