Allergic RhinitisNCT05129306
Impact of RYALTRIS® Nasal Spray on Patients' Reported Outcomes
An observational study of Allergic Rhinitis, run by Community and Patient Preference Research Pty Ltd at 1 site in Australia.
Trial summary
A real world evidence study that aims to understand the impact of RYALTRIS® nasal spray in patients with Allergic Rhinitis over a 28-day period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Observational
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- 17 Nov 2021to 14 Mar 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: The primary population will be patients with moderate to severe Seasonal Allergic Rhinitis (SAR) or Perennial Allergic Rhinitis (PAR) in Australia who have been newly prescribed RYALTRIS® for management of their disease.
Who may be able to join
- AR patients (moderate-to-severe SAR or PAR) with or without conjunctivitis who meet the following criteria will be offered the opportunity to participate in the study:
- Patients above 18 years old
- Fluent in English
- Patients newly prescribed RYALTRIS® who have not yet initiated treatment
- Willing and able to provide consent to participate
Who cannot join
- Potential participants will be excluded if they:
- Are employed by a pharmaceutical company (to avoid conflict of interest)
- Are employed by a vaccine company (to avoid conflict of interest)
- Do not have access to the internet (to ensure validity of the data)
- Are unable to read and understand English (to ensure validity of the data)
- are currently or have previously been on RYALTRIS®
Trial locations and contacts
1 site in 1 country.
Australia1 site
Community and Patient Preference Research Pty Ltd
Sydney, New South Wales, 2000
About this study
Official title: Impact of RYALTRIS® (Olopatadine Hydrochloride / Mometasone Furoate Monohydrate) Nasal Spray on Patients' Reported Outcomes
A real world evidence study that aims to understand the impact of RYALTRIS® nasal spray in patients with Allergic Rhinitis over a 28-day period.
Read the detailed description
The aim of this research is to develop a greater understanding of satisfaction with RYALTRIS® nasal spray in patients with Allergic Rhinitis (AR). There is currently no real-world evidence for patient satisfaction data with RYALTRIS® nasal spray. To address this knowledge gap and add to clinically relevant data to support Quality of Life (QoL) and patient reported outcomes, this research will evaluate the impact on quality of life (symptom control), using a Visual Analogue Scale (VAS), following initiation of RYALTRIS® to explore the relationship between baseline and subsequent QoL scores among patients initiated on RYALTRIS®.
- Conditions
- Allergic Rhinitis
- Being tested
- Observational
- Keywords
- Patient outcomes, Patient satisfaction, Quality of Life
- Medical subject headings
- Rhinitis, Allergic, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
In this observational study, participants with moderate to severe Allergic Rhinitis who were initiated on Ryaltris® nasal spray by their healthcare professional will complete an online survey before commencement of treatment and then at days 1, 7, and 14 from treatment initiation. Survey completion at day 28 after treatment initiation will be optional for participants based on ongoing use of RYALTRIS®.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with moderate to severe Allergic Rhinitis who have been prescribed RYALTRIS® nasal spray by their healthcare professional. Observational. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
The primary study endpoint is the overall VAS score to determine improvement of Allergic Rhinitis symptoms and quality of life.
Measured: 28 days
Secondary outcomes (5)
Overall Allergic Rhinitis nasal symptoms
Response to a visual analogue scale about their Allergic Rhinitis nasal symptoms
Measured: 28 days
Overall Allergic Rhinitis ocular symptoms
Response to a visual analogue scale about their Allergic Rhinitis ocular symptoms
Measured: 28 days
Sleep quality
Response to a visual analogue scale about their sleep quality
Measured: 28 days
Daily outdoor activities
Response to a visual analogue scale about their daily outdoor activities
Measured: 28 days
Work productivity
Response to a visual analogue scale about their work productivity
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start17 Nov 2021
- Primary completion14 Mar 2022
- Study completion14 Mar 2022
Why it stopped: Difficulty recruiting participants with current strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Community and Patient Preference Research Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seqirus Limited, Glenmark Pharmaceuticals S.A.
- Responsible party
- Sponsor
- Investigators
- Simon Fifer, PhD, Principal investigator, Community and Patient Preference Research Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129306
- Sponsor's protocol ID
- 20210902_1
- Status last verified
- Mar 2022
- First submitted
- 10 Nov 2021
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Australian Institute of Health and Welfare 2019. Allergic rhinitis ('hay fever'). Cat. no. PHE 257. Canberra: AIHW. Viewed 01 May 2020, https://www.aihw.gov.au/reports/chronic-respiratory-conditions/allergic-rhinitis-hay-fever/contents/allergic-rhinitis
Meltzer EO, Garadi R, Laforce C, Chadwick SJ, Berger WE, Gross G, Edwards MR, Crenshaw K, Wall GM. Comparative study of sensory attributes of two antihistamine nasal sprays: olopatadine 0.6% and azelastine 0.1%. Allergy Asthma Proc. 2008 Nov-Dec;29(6):659-68. doi: 10.2500/aap.2008.29.3181. Epub 2008 Dec 6.
PubMed 19144261Meltzer EO, Hadley J, Blaiss M, Benninger M, Kimel M, Kleinman L, Dupclay L, Garcia J, Leahy M, Georges G. Development of questionnaires to measure patient preferences for intranasal corticosteroids in patients with allergic rhinitis. Otolaryngol Head Neck Surg. 2005 Feb;132(2):197-207. doi: 10.1016/j.otohns.2004.10.010.
PubMed 15692526Price D, Klimek L, Galffy G, Emmeluth M, Koltun A, Kopietz F, Nguyen DT, van Weissenbruch R, Pohl W, Kuhl HC, Scadding G, Mullol J. Allergic rhinitis and asthma symptoms in a real-life study of MP-AzeFlu to treat multimorbid allergic rhinitis and asthma. Clin Mol Allergy. 2020 Aug 6;18:15. doi: 10.1186/s12948-020-00130-9. eCollection 2020.
PubMed 32782442
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of RYALTRIS® (Olopatadine Hydrochloride / Mometasone Furoate Monohydrate) Nasal Spray on Patients' Reported Outcomes
- ClinicalTrials.gov ID
- NCT05129306
- Acronym / sponsor ID
- 20210902_1
- Conditions
- Allergic Rhinitis
- Keywords
- Patient outcomes, Patient satisfaction, Quality of Life
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Difficulty recruiting participants with current strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Community and Patient Preference Research Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Seqirus Limited, Glenmark Pharmaceuticals S.A.
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 22 Nov 2021 (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.
A real world evidence study that aims to understand the impact of RYALTRIS® nasal spray in patients with Allergic Rhinitis over a 28-day period.
Detailed description
The aim of this research is to develop a greater understanding of satisfaction with RYALTRIS® nasal spray in patients with Allergic Rhinitis (AR). There is currently no real-world evidence for patient satisfaction data with RYALTRIS® nasal spray. To address this knowledge gap and add to clinically relevant data to support Quality of Life (QoL) and patient reported outcomes, this research will evaluate the impact on quality of life (symptom control), using a Visual Analogue Scale (VAS), following initiation of RYALTRIS® to explore the relationship between baseline and subsequent QoL scores among patients initiated on RYALTRIS®.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: ObservationalPatients with moderate to severe Allergic Rhinitis who have been prescribed RYALTRIS® nasal spray by their healthcare professional. Observational. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The primary population will be patients with moderate to severe Seasonal Allergic Rhinitis (SAR) or Perennial Allergic Rhinitis (PAR) in Australia who have been newly prescribed RYALTRIS® for management of their disease.
Key inclusion criteria (5 listed)
- AR patients (moderate-to-severe SAR or PAR) with or without conjunctivitis who meet the following criteria will be offered the opportunity to participate in the study:
- Patients above 18 years old
- Fluent in English
- Patients newly prescribed RYALTRIS® who have not yet initiated treatment
- Willing and able to provide consent to participate
Key exclusion criteria (6 listed)
- Are employed by a pharmaceutical company (to avoid conflict of interest)
- Are employed by a vaccine company (to avoid conflict of interest)
- Do not have access to the internet (to ensure validity of the data)
- Are unable to read and understand English (to ensure validity of the data)
- are currently or have previously been on RYALTRIS®
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 |
|---|---|---|
| ObservationalIn this observational study, participants with moderate to severe Allergic Rhinitis who were initiated on Ryaltris® nasal spray by their healthcare professional will complete an online survey before commencement of treatment and then at days 1, 7, and 14 from treatment initiation. Survey completion at day 28 after treatment initiation will be optional for participants based on ongoing use of RYALTRIS®. | Other | Patients |
Primary outcome
Visual analogue scale (VAS)
Time frame: 28 days
The primary study endpoint is the overall VAS score to determine improvement of Allergic Rhinitis symptoms and quality of life.
5 secondary outcomes
Overall Allergic Rhinitis nasal symptoms
Time frame: 28 days
Overall Allergic Rhinitis ocular symptoms
Time frame: 28 days
Sleep quality
Time frame: 28 days
Daily outdoor activities
Time frame: 28 days
Work productivity
Time frame: 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- BackgroundAustralian Institute of Health and Welfare 2019. Allergic rhinitis ('hay fever'). Cat. no. PHE 257. Canberra: AIHW. Viewed 01 May 2020, https://www.aihw.gov.au/reports/chronic-respiratory-conditions/allergic-rhinitis-hay-fever/contents/allergic-rhinitis
- Background: PubMed 19144261Meltzer EO, Garadi R, Laforce C, Chadwick SJ, Berger WE, Gross G, Edwards MR, Crenshaw K, Wall GM. Comparative study of sensory attributes of two antihistamine nasal sprays: olopatadine 0.6% and azelastine 0.1%. Allergy Asthma Proc. 2008 Nov-Dec;29(6):659-68. doi: 10.2500/aap.2008.29.3181. Epub 2008 Dec 6.
- Background: PubMed 15692526Meltzer EO, Hadley J, Blaiss M, Benninger M, Kimel M, Kleinman L, Dupclay L, Garcia J, Leahy M, Georges G. Development of questionnaires to measure patient preferences for intranasal corticosteroids in patients with allergic rhinitis. Otolaryngol Head Neck Surg. 2005 Feb;132(2):197-207. doi: 10.1016/j.otohns.2004.10.010.
- Background: PubMed 32782442Price D, Klimek L, Galffy G, Emmeluth M, Koltun A, Kopietz F, Nguyen DT, van Weissenbruch R, Pohl W, Kuhl HC, Scadding G, Mullol J. Allergic rhinitis and asthma symptoms in a real-life study of MP-AzeFlu to treat multimorbid allergic rhinitis and asthma. Clin Mol Allergy. 2020 Aug 6;18:15. doi: 10.1186/s12948-020-00130-9. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
Simon Fifer, PhD principal investigator
Community and Patient Preference Research Pty Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis, run by Community and Patient Preference Research Pty Ltd 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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 7 Apr 2022. 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 withdrawn before enrolling participants, so there are no results.
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?
Visual analogue scale (VAS) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05129306, which also lists 4 linked publications.
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 7 Apr 2022.