Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000772549
Ethics application status
Approved
Date submitted
12/06/2024
Date registered
25/06/2024
Date last updated
25/06/2024
Date data sharing statement initially provided
25/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to evaluate the effectiveness of intranasal Botulinum Toxin Type A Spray for patients with Rhinitis
Scientific title
A pilot study to evaluate the effectiveness of intranasal Botulinum Toxin Type A Spray for adult patients with Rhinitis
Secondary ID [1] 312326 0
none
Universal Trial Number (UTN)
Trial acronym
None
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Allergic Rhinitis 334084 0
Non-Allergic Rhinitis 334159 0
Condition category
Condition code
Inflammatory and Immune System 330765 330765 0 0
Allergies
Inflammatory and Immune System 330766 330766 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
40 units Botulinum toxin type A administered topically intranasally using a mucosal atomisation device. 20 units will be administered per nostril. This is a Once only dose administered by study investigator in ENT clinic at Baseline (day 0).
The details of the dose will be documented on the patient case report form including check for correct dose and check that complete dose is administered.
Intervention code [1] 328810 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338529 0
Total nasal symptom scores
Timepoint [1] 338529 0
Baseline (day 0), 2 Weeks post-baseline and 4 Weeks post-baseline
Secondary outcome [1] 436278 0
Overall symptom change measured on Visual Analogue scale
Timepoint [1] 436278 0
Baseline (Day 0), 2 weeks post-baseline and 4 weeks post-baseline
Secondary outcome [2] 436282 0
Peak Nasal Inspiratory Flow changes
Timepoint [2] 436282 0
Baseline (Day 0) and 4 weeks post-baseline
Secondary outcome [3] 436283 0
Nasal Endoscopy Changes
Timepoint [3] 436283 0
Baseline (Day 0) and 4 weeks post-baseline
Secondary outcome [4] 436284 0
Adverse Events records
Timepoint [4] 436284 0
From signing of consent to end of study

Eligibility
Key inclusion criteria
1. Patients greater than or equal to 18 years
2. Clinically confirmed diagnosis of allergic or non-allergic rhinitis.
3. Prior Radioallergosorbent test (RAST) test and immunoglobulin E ( IgE) level (as part of the patient’s standardised medical treatment).
4. Incomplete management of symptoms despite appropriate medical treatment (intra-nasal corticosteroid and nasal douching)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients less than 18 years
2. Participants who are unable to provide informed consent.
3. Participants who are pregnant, breast feeding or planning to become pregnant during study.
4. Participants with an absolute contraindication to botulinum toxin type A specifically allergy, pregnancy, coexisting myasthenia gravis.
5. Coexisting chronic rhinosinusitis.
6. Subjects with known hypersensitivity or contraindications to mometasone nasal spray.
7. Participants who have been on an active investigational therapy within 1 month prior to screening
8. Women of childbearing potential who are not willing to use double barrier method of contraception during the study. That is:
-Use of contraceptive pill or intrauterine device (IUD) or similar
-and Condoms
9. Currently on any medication that may affect the results in an unpredictable manner.
10. The participant does not agree to comply with or is unable to meet all study requirements for the duration of the study period.
11. Participants deemed by the investigator to be unsuitable for participation in the study.

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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/07/2024
Actual
Date of last participant enrolment
Anticipated
31/08/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 42716 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 316723 0
Other
Name [1] 316723 0
Metro North Hospital and Health Service
Country [1] 316723 0
Australia
Primary sponsor type
Other
Name
Metro North Hospital and Health Service
Address
Country
Australia
Secondary sponsor category [1] 318934 0
Other
Name [1] 318934 0
RBWH ENT Clinical Trials Group
Address [1] 318934 0
Country [1] 318934 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315498 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [1] 315498 0
https://metronorth.health.qld.gov.au/research/ethics-and-governance/human-research-ethics-committee
Ethics committee country [1] 315498 0
Australia
Date submitted for ethics approval [1] 315498 0
29/04/2024
Approval date [1] 315498 0
11/06/2024
Ethics approval number [1] 315498 0
HREC/2024/MNHA/107054

Summary
Brief summary
Rhinitis affects approximately 20 to 40% of the population and is currently poorly controlled in approximately 15% of the population with standard treatment. Botulinum toxin type A spray could provide a painless, easily applied and potentially alternate treatment for sufferers. Currently there is wide use in cosmetic clinics but few supporting clinical trials.
. HYPOTHESIS
We aim to test the hypothesis that botulinum toxin type A is an effective treatment for rhinitis when delivered via intranasal spray, as measured by total nasal symptom score.
INTERVENTION
40 units Botulinum toxin type A administered topically intranasally using the LMA® MAD Nasal™ Intranasal Mucosal Atomization Device by Teleflex (ARTG number 294634). 20 units will be administered per nostril at the base line visit of the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134886 0
Dr Abigail Walker
Address 134886 0
ENT, Level 8, RBWH, 40 Butterfield Street, Herston QLD 4029
Country 134886 0
United Kingdom
Phone 134886 0
+61 7 3646 0946
Fax 134886 0
Email 134886 0
abigail.walker@health.qld.gov.au
Contact person for public queries
Name 134887 0
Kathryn Girling
Address 134887 0
ENT, Level 8, RBWH, 40 Butterfield Street, Herston QLD 4029
Country 134887 0
Australia
Phone 134887 0
+61 7 3646 0949
Fax 134887 0
Email 134887 0
RBWH-ENT-Research@health.qld.gov.au
Contact person for scientific queries
Name 134888 0
Kathryn Girling
Address 134888 0
ENT, Level 8, RBWH, 40 Butterfield Street, Herston QLD 4029
Country 134888 0
Australia
Phone 134888 0
+61 736460946
Fax 134888 0
Email 134888 0
RBWH-ENT-Research@health.qld.gov.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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23885Ethical approval    387957-(Uploaded-12-06-2024-16-59-08)-107054 HREC Approval Ltr_11.06.2024.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.