Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001727831
Ethics application status
Approved
Date submitted
19/10/2021
Date registered
17/12/2021
Date last updated
25/01/2023
Date data sharing statement initially provided
17/12/2021
Date results information initially provided
25/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Study of AM-301 Nasal Spray in Seasonal Allergic Rhinitis
Scientific title
Clinical Performance and Safety of AM-301 Nasal Spray in Seasonal Allergic Rhinitis (NASAR)
Secondary ID [1] 305437 0
AM-301-CL-20-04
Universal Trial Number (UTN)
Trial acronym
NASAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Seasonal Allergic Rhinitis 323808 0
Condition category
Condition code
Inflammatory and Immune System 321311 321311 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of the study is to compare AM-301 nasal spray with a drug free standard of care product in the clinical performance and safety over a treatment period of 14 days. AM-301 is a thixotropic, aqueous gel emulsion. It works by forming a protective layer on the nasal mucosa that acts as a mechanical barrier against allergens.
Subjects will be randomized to 1 of 2 treatment groups at a ratio of 1:1
AM-301 will be self-administered 1 puff /nostril 3 times per day or as needed (not more than 8 sprays/nostril per day) for 2 weeks with each actuation delivering 0.14 mL.

Adherence to dosing is being monitored via a self reported diary and patient facing instructions on IP administration with specified dosing will be provided.

Intervention code [1] 321983 0
Treatment: Devices
Comparator / control treatment
Saline nasal spray, ie, a drug free standard-of-care product commercially available in Australia will be used as a comparator

Comparator to be self-administered 1 puff/nostril 3 times per day or as needed (Not more than 8 sprays/nostril per day) for 2 weeks.
Saline spray also delivers 0.14 mL actuation.

Adherence to dosing is being monitored via a self reported diary and patient facing instructions on comparator administration with specified dosing will be provided.
Control group
Active

Outcomes
Primary outcome [1] 329097 0
Total Nasal Symptom Score of subjects with Allergic rhinitis (AR) after repeated administration of AM-301 nasal spray compared with a drug-free standard of care.
Timepoint [1] 329097 0
Assessed daily from day 1 to day 14 (primary endpoint) post-intervention commencement
Secondary outcome [1] 401486 0
Occurrence and severity of Adverse events (AEs) and Serious adverse events (SAEs) under treatment with AM-301 or a drug free standard of care and will be coded using the most current version of the MedDRA®
Timepoint [1] 401486 0
Assessed once daily from Time of consent to follow up (22 days post-intervention commencement)
Secondary outcome [2] 402021 0
Rhino conjunctivitis Quality of Life questionnaire of subjects with Allergic rhinitis (AR) after repeated administration of AM-301 nasal spray compared with a drug-free standard of care.
Timepoint [2] 402021 0
Rhino conjunctivitis Quality of Life questionnaire will be completed 5 times during the study. At Screening visit, Day 1, Day 8, Day 15, and Follow-up (Day 22) post-intervention commencement
Secondary outcome [3] 402022 0
Use of relief medication.
The subjects are required to complete all assessment in ePRO (electronic diary) on a daily basis to record travel, outdoor activity, Use of relief and other medication
Timepoint [3] 402022 0
From baseline Run-In to end (7 days prior to intervention commencement) to end of study treatment (14 days post-intervention commencement) and follow up (22 days post-intervention commencement)
Secondary outcome [4] 402023 0
Pattern of use of AM-301 nasal spray
The subjects are required to complete all assessment in ePRO (electronic diary) on a daily basis from to record use of medication
Timepoint [4] 402023 0
Assessed daily once from day 1 to day 14 post-intervention commencement
Secondary outcome [5] 402914 0
Global impression of Efficacy by physicians of AM-301 compared with a drug-free standard of care
Timepoint [5] 402914 0
Global impression of Efficacy scale will be completed daily from Day 1 to day 15
Assessed once on day 15 post-intervention commencement
Secondary outcome [6] 402915 0
Global impression of Efficacy by subjects of AM-301 compared with a drug-free standard of care
Timepoint [6] 402915 0
Global impression of Efficacy scale will be completed daily from Day 1 to day 15
Assessed once on day 15 post-intervention commencement

Eligibility
Key inclusion criteria
1. Clinical history of seasonal AR, as reported by the subject, with symptoms for more than 2 seasons with exacerbations during the study season for the relevant seasonal allergen (eg, tree/grass pollen).
2. Confirmed with positive skin prick test (ie, wheal greater than or equal to 3 mm larger than the diluent control with erythema) or in vitro tests for specific immunoglobulin E (IgE) at Baseline or within 12 months before enrolment.
3. Age more than or equal to 18 years and less than or equal to 75 years on the day of Screening.
4. Active symptoms of seasonal AR with a TNSS score greater than or equal to 5 (based on run-in) at randomization.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Ongoing or in the 7 days prior to Screening, presence of active, medium or severe symptoms of rhinitis (non-allergic), acute inflammation of the nose or paranasal sinuses.
2. Uncontrolled asthma, under treatment with any class of medications other than inhaled short-acting beta-2 agonists or with known FEV1 less than 70 percent (in previous 6 months).
3. Ongoing or in the previous 4 weeks, diagnosis or symptoms of acute respiratory infections.
4. Surgery of the nose or paranasal sinuses in the previous 8 weeks.
5. Long-term continuous inhaled, intranasal glucocorticosteroids (intermittent use is allowed).
6. Long-term continuous use of the oral or systemic H1 antihistamines, topical antiallergic treatment, nasal vasoconstrictors (intermittent use of provided relief medication is allowed during the trial).
7. Immunotherapy starting at enrolment or with dose changed within 1 month before Screening.
8. Treatment with leukotriene receptor antagonists (concomitant or up to one week before Screening) or nonsteroidal anti-inflammatory drugs (NSAIDs) (NSAID intermittent use is allowed as relief medication).

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)
The allocation procedures is per EDC (Electronic Data Capture).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomization list will be prepared using a statistical software package by a Biostatistician.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/11/2021
Date of last participant enrolment
Anticipated
23/12/2022
Actual
23/12/2022
Date of last data collection
Anticipated
27/01/2023
Actual
12/01/2023
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 20645 0
Northern Beaches Clinical Research - Brookvale
Recruitment hospital [2] 20646 0
Emeritus Research - Camberwell
Recruitment hospital [3] 20647 0
Emeritus Research - Botany - Botany
Recruitment hospital [4] 20648 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [5] 22361 0
Griffith University Clinical Trials Unit - Southport
Recruitment hospital [6] 22362 0
Austrials - Taringa - Taringa
Recruitment hospital [7] 22363 0
Austrials - Wellers Hill - Tarragindi
Recruitment hospital [8] 22364 0
Holdsworth House Medical Brisbane - Fortitude Valley
Recruitment hospital [9] 23517 0
Captain Stirling Medical Centre - Nedlands
Recruitment hospital [10] 23518 0
Cairns and Hinterland Hospital Clinical Research Unit - Cairns
Recruitment hospital [11] 23519 0
Paragon Medical & Dental Centre - Modbury
Recruitment hospital [12] 23520 0
Hatherley Medical Centre - Winthrop
Recruitment postcode(s) [1] 35437 0
2010 - Sydney
Recruitment postcode(s) [2] 35436 0
2019 - Botany
Recruitment postcode(s) [3] 35434 0
2100 - Brookvale
Recruitment postcode(s) [4] 35435 0
3124 - Camberwell
Recruitment postcode(s) [5] 37527 0
4006 - Fortitude Valley
Recruitment postcode(s) [6] 37525 0
4068 - Taringa
Recruitment postcode(s) [7] 37526 0
4121 - Tarragindi
Recruitment postcode(s) [8] 37524 0
4215 - Southport
Recruitment postcode(s) [9] 38926 0
4870 - Cairns
Recruitment postcode(s) [10] 38927 0
5092 - Modbury
Recruitment postcode(s) [11] 38925 0
6009 - Nedlands
Recruitment postcode(s) [12] 38928 0
6150 - Winthrop

Funding & Sponsors
Funding source category [1] 309796 0
Commercial sector/Industry
Name [1] 309796 0
Auris Medical Pty. Ltd.
Country [1] 309796 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Auris Medical Pty. Ltd.
Address
58 Gipps Street
Collingwood, VIC 3066, Australia
Country
Australia
Secondary sponsor category [1] 310823 0
None
Name [1] 310823 0
Address [1] 310823 0
Country [1] 310823 0
Other collaborator category [1] 282007 0
Commercial sector/Industry
Name [1] 282007 0
Novotech (Australia) Pty Limited
Address [1] 282007 0
Level 3, 235 Pyrmont Street, Pyrmont NSW 2009
Country [1] 282007 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309543 0
Bellberry Human Research Ethics Committee C
Ethics committee address [1] 309543 0
123 Glen Osmond Road, Eastwood , Adelaide, South Australia 5063
Ethics committee country [1] 309543 0
Australia
Date submitted for ethics approval [1] 309543 0
11/08/2021
Approval date [1] 309543 0
29/09/2021
Ethics approval number [1] 309543 0

Summary
Brief summary
A study to determine the safety and efficacy of treatment with AM-301 in subjects who suffer from seasonal AR. In this study, a saline nasal spray, ie, a drug free standard-of-care product commercially available in Australia will be used as a comparator
After Screening, subjects will undergo a 7 day Run-in Period to establish Baseline, followed by a 2-week Treatment Period.
The AM-301 medical nasal spray device is being developed as a nasal spray intended to treat Allergic Rhinitis by limiting exposure to airborne allergens and promoting alleviation of allergic symptoms triggered by the inhalation of airborne allergens. It is hoped that the AM-301 nasal spray device will be better than the standard of care saline spray nasal spray device (comparator) to help in improvement of Allergic Rhinitis symptoms.
Trial website
Trial related presentations / publications
Public notes
Additional exclusion criteria: Positive rapid-result COVID-19 antigen test.

Contacts
Principal investigator
Name 114526 0
Dr Anthony McGirr
Address 114526 0
Northern Beaches Clinical Research
Suite 201, level 2, 696 Pittwater Road, Brookvale NSW, 2100
Country 114526 0
Australia
Phone 114526 0
+61 1300559676
Fax 114526 0
Email 114526 0
amcgirr@northernbeachesclinicalresearch.com
Contact person for public queries
Name 114527 0
Mr Kenil Ghorecha
Address 114527 0
Novotech India Private Limited
Unit No. 104, Embassy Square, No. 148
Infantry Road,
Bangalore, KARNATAKA
560001, India
Country 114527 0
India
Phone 114527 0
+918264174180
Fax 114527 0
Email 114527 0
Kenil.Ghorecha@novotech-cro.com
Contact person for scientific queries
Name 114528 0
Mr Kenil Ghorecha
Address 114528 0
Novotech India Private Limited
Unit No. 104, Embassy Square, No. 148
Infantry Road,
Bangalore, KARNATAKA
560001, India
Country 114528 0
India
Phone 114528 0
+918264174180
Fax 114528 0
Email 114528 0
Kenil.Ghorecha@novotech-cro.com

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.