AllergyARISENCT06686446
Allergic Rhinitis Improvement Through Strategic Education: The ARISE Trial
A study testing Enhanced Education Package in people with Allergy, run by Murdoch Childrens Research Institute at 1 site in Australia.
Trial summary
Allergic Rhinitis, or hay fever, is a common allergic chronic condition that affects many Australians, with its prevalence rates increasing each year due to environmental factors and affects all age groups. Read more about this study
- Who is it for?
- Ages 14 to 29 years
- Conditions the study is for
- Allergy
- What is being tested?
- Enhanced Education Package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteAustralia
- Study dates
- 22 Aug 2025to 5 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents and young adults aged 14-29 years experiencing moderate to severe AR symptoms (defined by ARIA guidelines if AR symptoms significantly affect sleep or activities of daily living, and/or if they are considered bothersome (15)) and is using or commencing INCS or combination INCS+INAH treatment.
- A previous positive SPT and/or sIgE to at least one aeroallergen
- Ability to understand and comply with study requirements and provide informed consent
Who cannot join
- 1. Current or previous treatment for AR with aeroallergen immunotherapy (patients will be specifically asked if they have ever received subcutaneous immunotherapy (SCIT) or sublingual immunotherapy (SLIT) for aeroallergens such as pollen, house dust mite, cats, dogs and horses)
Trial locations and contacts
1 site in 1 country.
Australia1 site
Murdoch Children's Research Institute
Parkville, Victoria, 3052
About this study
Allergic Rhinitis, or hay fever, is a common allergic chronic condition that affects many Australians, with its prevalence rates increasing each year due to environmental factors and affects all age groups. Evidence shows a large proportion of individuals with hay fever, whether it is seasonal, perennial (all year round) or occupational, will not seek medical help and instead rely on over the counter medications. This often leads to inadequate treatment and poor control of symptoms, impacting their quality of life, symptom burnout and economic burden.
There are effective treatments available including Intranasal Corticosteroid (INCS) sprays or combination INCS + Intranasal Antihistamine (INAH) sprays, but they need to be used correctly and as directed for best results. Previous studies have shown that many adults and children who use INCS+INAH do not know the right way to use them because they are not provided with enough education and awareness. Studies also show that adolescents and young adults are more likely to not follow their treatment plan because they worry about minor side effects INCS or INCS+INAH can cause, and misconceptions that can come from a lack of education. However, these concerns can be avoided if they are guided and educated on the correct techniques, knowledge through repeat education.
Read the detailed description
This study will be a prospective decentralised interventional trial that will address the following research question: In adolescents and young adults with moderate to severe AR does six weeks of a targeted intervention package of patient education tools reduce AR symptoms and positively impact other patient reported outcomes compared to standard AR management?
Trial participants aged 14-29 will be recruited via both direct to patient advertising and participating recruitment sites (for example, allergy specialists, hospital outpatient clinics and general practitioners), located across Australia.
Participants will be currently experiencing AR symptoms of at least moderate to severe severity (as per ARIA guidelines), have a previous positive SPT and/or sIgE to at least one aeroallergen, and will be using or about to start using either a INCS or a combined INCS+INAH spray.
Patients interested in participating in the trial will be able to register their interest via an online webform and complete a few eligibility screening questions. The central study team will then undertake an informed consent process via telehealth. As part of informed consent, participants are asked to allow the study team to request access to their skin prick test and/or sIgE results. Consented participants will be randomised 1:1 to either the intervention group who receive an Enhanced Education Package (EEP) which is a targeted set of patient education tools and weekly email/SMS reminders over a 6 week period, or to the control group (standard of care), which may include management by a general practitioner, specialist, pharmacist, or self-management). All participants will be assessed at baseline and 6 weeks post-randomisation on physical symptoms (nasal and ocular symptoms) and quality of life. A validated questionnaire to assess knowledge, attitude and practice (KAP) of nasal steroid and its uses, will also be given to all participants in each group at both timepoints. All assessment measures will be repeated at 9-months post-randomisation to look at longer term outcomes.
- Conditions
- Allergy
- Being tested
- Enhanced Education Package
- Keywords
- Allergy Rhinitis
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Education PackageBehavioural
Participants randomised to the intervention arm will receive an advanced patient education toolkit and reminders delivered by email/SMS in addition to the standard education provided by their treating clinician.
Weekly repeat reminders - these reminders will be sent via either SMS or email over a period of 3 months. They will instruct and remind the participant to take their INCS/INAH as per their treating clinician recommendation and why it is important to take it as instructed.
Education Toolkit - contains links to websites of key organisations including the National Allergy Council (NAC), Allergy \& Anaphylaxis Australia (A\&AA), Australasian Society of Clinical Immunology and Allergy (ASCIA), National Asthma Council Australia (NACA) and AusPollen which include educational videos and other resources.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Education Package | Experimental | Participants randomised to the intervention arm will receive an advanced patient education toolkit and reminders delivered by email/SMS in addition to the standard education which may include management by a general practitioner, specialist, pharmacist, or self-management.
The EEP will contain:
* Dosing/frequency - links for package inserts for INCS and INCS+INAH
* Correct INCS or INCS+INAH technique - the study team will ask participants to show them the correct technique in taking their nasal spray
* Weekly repeat reminders - these reminders will be sent via either SMS or email over a period of 6 weeks. They will instruct and remind the participant to take their INCS or INCS+INAH as per their treating clinician recommendation and why it is important to take it as instructed.
* Education Toolkit - contains links to websites of key organisations which include educational videos and other resources Receives: Behavioral: Enhanced Education Package |
| Standard of care | No intervention | Participants randomised to the control arm will receive standard of care education, which may include management by a general practitioner, specialist, pharmacist, or self-management. After randomisation, the study team will confirm what education the participants have received and that they can display the correct technique in taking their nasal spray. The research assistant/study nurse can re-educate the participant until the correct technique is displayed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the two treatment arms (experimental versus standard of care) in participant nasal symptomatology: Change in total scores 6 weeks post commencement of INCS or INAH+INCS
Patient reported nasal symptomatology scores completed using the validated Total Nasal Symptom Score (TNSS) questionnaire. The TNSS questionnaire is a validated questionnaire to assess nasal symptomatology and consists of 3 questions. Total scores are calculated by adding the sum of completed items. Questions are based on a 3 point Likert scale, with scores of 6 or more indicating moderate to severe allergic rhinitis.
Measured: Baseline and 6-weeks post-randomisation
Secondary outcomes (6)
Difference between treatment arms in participant nasal symptomatology: Change in total scores 9 months post commencement of INCS or INAH+INCS
Patient reported nasal symptomatology scores completed using the validated Total Nasal Symptom Score (TNSS) questionnaire. The TNSS questionnaire is validated questionnaire to assess nasal symptomatology and consists of 3 questions. Total scores are calculated by adding the sum of completed items. Questions are based on a 3 point Likert scale, with scores of 6 or more indicating moderate to severe allergic rhinitis.
Measured: Baseline and 9-months post-randomisation
Change between treatment arms in participant ocular symptomatology
Patient reported ocular symptomatology scores completed using the Total ocular symptom score (TOSS) questionnaire. The TOSS questionnaire is validated questionnaire to assess ocular symptomatology and consists of 3 questions. Total scores are calculated by adding the sum of completed items. Questions are based on a 3 point Likert scale, with scores of 6 or more indicating moderate to severe allergic rhinitis.
Measured: Baseline, 6 weeks post randomisation and 9 months post randomisation
Mean change between treatment arms in Quality of Life Scores using the Rhinitis Control Assessment Test (RCAT)
The Rhinitis Control Assessment Test (RCAT) questionnaire is validated questionnaire to assess Allergy Rhinitis symptoms and impact on quality of life. It is completed by participants and consists of 6 questionnaires. Total scores are calculated by adding the sum of completed items. Questions are based on a 5 point Likert scale, with scores of 21 or less indicating greater impact on quality of life.
Measured: Baseline, 6 weeks post randomisation, 9 months post randomisation
Change between treatment arms in participant knowledge, attitude and practice on nasal steroid and its uses
The Allergic Rhinitis Knowledge, Attitude and Practice (KAP) are disease-specific questionnaire for participants with allergy rhinitis. The KAP is completed by participants and consists of 12 items over 3 domains (knowledge, attitudes and practice). The knowledge section is based on a 3 point Likert scale using Yes, Not sure and No. Attitude section is based on a 6 point Likert scale and total and scores are calculated by the sum of completed items. Higher scores indicating positive attitudes towards their health condition. Practice section is based on a 5 point Likert scale and total and scores are calculated by the sum of completed items. Higher scores indicating excellent practice in treating their health condition. Each section will be scored separately.
Measured: Baseline, 6 weeks post randomisation and 9 months post randomisation
Change between treatment arms in total scores for participant INCS or INCS+INAH application technique
INCS/INAH application technique will be observed by the study nurses/research assistants and scored using the current Australasian Society of Clinical Immunology and Allergy (ASCIA) Guidelines checklist. There are total of 6 steps and each step achieved will be given a score of 1. If not achieved a score of 0 will be given. Total scores are calculated by the sum of all 6 steps. Higher scores indicating excellent knowledge and practice in technique.
Measured: Baseline, 6 weeks and 9 months post randomisation
Change between treatment arms in participant engagement with educational resources from baseline to 6 weeks
Participants randomized to the EEP will be asked about education resources at baseline and if they are currently using them. Each participant will receive education toolkit with links to the current educational resources available via eNewsletters every 2 weeks during the 6 week intervention window. Campaign monitor analytics will be used to record number of clicks on the educational resources provided. Higher the clicks indicates greater participant engagement.
Measured: Baseline then at 2 weeks, 4 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start22 Aug 2025
- Primary completion5 Feb 2026
- Study completion5 Feb 2026
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, interventional, randomised trial, evaluating the impact and effectiveness of a new AR education package used in conjunction with daily INCS or INCS+INAH treatment to reduce AR-related symptomatology and improve quality of life, in comparison to the standard of care education that is currently provided. A decentralized clinical trial model will be used to facilitate and augment the recruitment of participants across different geographical locations around Australia to align with the seasonal pollen changes in various states and territories. Consented participants will be randomised 1:1 to either the intervention group who receive an Enhanced Education Package (EEP) which is a targeted set of patient education tools and weekly email/SMS reminders over a 6 week period, or to the control group (standard of care), which may include management by a general practitioner, specialist, pharmacist, or self-management).
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirsten M Perrett, MBBS, FRACP, PhD, Principal investigator, Murdoch Childrens Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686446
- Sponsor's protocol ID
- NACE-003
- Acronym
- ARISE
- Status last verified
- Feb 2026
- First submitted
- 11 Nov 2024
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the data has been cleaned and database has been locked, the de-identified data and if consented, personal identifying information, will be shared to National Allergy Centre of Excellence (NACE) Allergy BioRepository via a safe and secure mechanism, for storage and use in future allergy research.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allergic Rhinitis Improvement Through Strategic Education: The ARISE Trial
- ClinicalTrials.gov ID
- NCT06686446
- Acronym / sponsor ID
- ARISE / NACE-003
- Conditions
- Allergy
- Keywords
- Allergy Rhinitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Allergic Rhinitis, or hay fever, is a common allergic chronic condition that affects many Australians, with its prevalence rates increasing each year due to environmental factors and affects all age groups. Evidence shows a large proportion of individuals with hay fever, whether it is seasonal, perennial (all year round) or occupational, will not seek medical help and instead rely on over the counter medications. This often leads to inadequate treatment and poor control of symptoms, impacting their quality of life, symptom burnout and economic burden.
There are effective treatments available including Intranasal Corticosteroid (INCS) sprays or combination INCS + Intranasal Antihistamine (INAH) sprays, but they need to be used correctly and as directed for best results. Previous studies have shown that many adults and children who use INCS+INAH do not know the right way to use them because they are not provided with enough education and awareness. Studies also show that adolescents and young adults are more likely to not follow their treatment plan because they worry about minor side effects INCS or INCS+INAH can cause, and misconceptions that can come from a lack of education. However, these concerns can be avoided if they are guided and educated on the correct techniques, knowledge through repeat education.
Detailed description
This study will be a prospective decentralised interventional trial that will address the following research question: In adolescents and young adults with moderate to severe AR does six weeks of a targeted intervention package of patient education tools reduce AR symptoms and positively impact other patient reported outcomes compared to standard AR management?
Trial participants aged 14-29 will be recruited via both direct to patient advertising and participating recruitment sites (for example, allergy specialists, hospital outpatient clinics and general practitioners), located across Australia.
Participants will be currently experiencing AR symptoms of at least moderate to severe severity (as per ARIA guidelines), have a previous positive SPT and/or sIgE to at least one aeroallergen, and will be using or about to start using either a INCS or a combined INCS+INAH spray.
Patients interested in participating in the trial will be able to register their interest via an online webform and complete a few eligibility screening questions. The central study team will then undertake an informed consent process via telehealth. As part of informed consent, participants are asked to allow the study team to request access to their skin prick test and/or sIgE results. Consented participants will be randomised 1:1 to either the intervention group who receive an Enhanced Education Package (EEP) which is a targeted set of patient education tools and weekly email/SMS reminders over a 6 week period, or to the control group (standard of care), which may include management by a general practitioner, specialist, pharmacist, or self-management). All participants will be assessed at baseline and 6 weeks post-randomisation on physical symptoms (nasal and ocular symptoms) and quality of life. A validated questionnaire to assess knowledge, attitude and practice (KAP) of nasal steroid and its uses, will also be given to all participants in each group at both timepoints. All assessment measures will be repeated at 9-months post-randomisation to look at longer term outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, interventional, randomised trial, evaluating the impact and effectiveness of a new AR education package used in conjunction with daily INCS or INCS+INAH treatment to reduce AR-related symptomatology and improve quality of life, in comparison to the standard of care education that is currently provided. A decentralized clinical trial model will be used to facilitate and augment the recruitment of participants across different geographical locations around Australia to align with the seasonal pollen changes in various states and territories. Consented participants will be randomised 1:1 to either the intervention group who receive an Enhanced Education Package (EEP) which is a targeted set of patient education tools and weekly email/SMS reminders over a 6 week period, or to the control group (standard of care), which may include management by a general practitioner, specialist, pharmacist, or self-management).
| Arm | Type | Receives |
|---|---|---|
| Enhanced Education Package | Experimental | Behavioral: Enhanced Education PackageParticipants randomised to the intervention arm will receive an advanced patient education toolkit and reminders delivered by email/SMS in addition to the standard education which may include management by a general practitioner, specialist, pharmacist, or self-management. The EEP will contain: * Dosing/frequency - links for package inserts for INCS and INCS+INAH * Correct INCS or INCS+INAH technique - the study team will ask participants to show them the correct technique in taking their nasal spray * Weekly repeat reminders - these reminders will be sent via either SMS or email over a period of 6 weeks. They will instruct and remind the participant to take their INCS or INCS+INAH as per their treating clinician recommendation and why it is important to take it as instructed. * Education Toolkit - contains links to websites of key organisations which include educational videos and other resources |
| Standard of care | No intervention | –Participants randomised to the control arm will receive standard of care education, which may include management by a general practitioner, specialist, pharmacist, or self-management. After randomisation, the study team will confirm what education the participants have received and that they can display the correct technique in taking their nasal spray. The research assistant/study nurse can re-educate the participant until the correct technique is displayed. |
Who may qualify
- Ages
- 14 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Adolescents and young adults aged 14-29 years experiencing moderate to severe AR symptoms (defined by ARIA guidelines if AR symptoms significantly affect sleep or activities of daily living, and/or if they are considered bothersome (15)) and is using or commencing INCS or combination INCS+INAH treatment.
- A previous positive SPT and/or sIgE to at least one aeroallergen
- Ability to understand and comply with study requirements and provide informed consent
Key exclusion criteria (1 listed)
- 1. Current or previous treatment for AR with aeroallergen immunotherapy (patients will be specifically asked if they have ever received subcutaneous immunotherapy (SCIT) or sublingual immunotherapy (SLIT) for aeroallergens such as pollen, house dust mite, cats, dogs and horses)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Education PackageParticipants randomised to the intervention arm will receive an advanced patient education toolkit and reminders delivered by email/SMS in addition to the standard education provided by their treating clinician. Weekly repeat reminders - these reminders will be sent via either SMS or email over a period of 3 months. They will instruct and remind the participant to take their INCS/INAH as per their treating clinician recommendation and why it is important to take it as instructed. Education Toolkit - contains links to websites of key organisations including the National Allergy Council (NAC), Allergy \& Anaphylaxis Australia (A\&AA), Australasian Society of Clinical Immunology and Allergy (ASCIA), National Asthma Council Australia (NACA) and AusPollen which include educational videos and other resources. | Behavioural | Enhanced Education Package |
Primary outcome
Difference between the two treatment arms (experimental versus standard of care) in participant nasal symptomatology: Change in total scores 6 weeks post commencement of INCS or INAH+INCS
Time frame: Baseline and 6-weeks post-randomisation
Patient reported nasal symptomatology scores completed using the validated Total Nasal Symptom Score (TNSS) questionnaire. The TNSS questionnaire is a validated questionnaire to assess nasal symptomatology and consists of 3 questions. Total scores are calculated by adding the sum of completed items. Questions are based on a 3 point Likert scale, with scores of 6 or more indicating moderate to severe allergic rhinitis.
6 secondary outcomes
Difference between treatment arms in participant nasal symptomatology: Change in total scores 9 months post commencement of INCS or INAH+INCS
Time frame: Baseline and 9-months post-randomisation
Change between treatment arms in participant ocular symptomatology
Time frame: Baseline, 6 weeks post randomisation and 9 months post randomisation
Mean change between treatment arms in Quality of Life Scores using the Rhinitis Control Assessment Test (RCAT)
Time frame: Baseline, 6 weeks post randomisation, 9 months post randomisation
Change between treatment arms in participant knowledge, attitude and practice on nasal steroid and its uses
Time frame: Baseline, 6 weeks post randomisation and 9 months post randomisation
Change between treatment arms in total scores for participant INCS or INCS+INAH application technique
Time frame: Baseline, 6 weeks and 9 months post randomisation
Change between treatment arms in participant engagement with educational resources from baseline to 6 weeks
Time frame: Baseline then at 2 weeks, 4 weeks, 6 weeks
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- ARISE trial informationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After the data has been cleaned and database has been locked, the de-identified data and if consented, personal identifying information, will be shared to National Allergy Centre of Excellence (NACE) Allergy BioRepository via a safe and secure mechanism, for storage and use in future allergy research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten M Perrett, MBBS, FRACP, PhD principal investigator
Murdoch Childrens Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Education Package in people with Allergy, run by Murdoch Childrens Research Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between the two treatment arms (experimental versus standard of care) in participant nasal symptomatology: Change in total scores 6 weeks post commencement of INCS or INAH+INCS (time frame: Baseline and 6-weeks post-randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.