Allergic Disorder of Respiratory SystemACARAYNCT07196527
Evaluation of the Clinical Efficacy of PURESSENTIEL Allergy Protection Nasal Spray (SNPA®) in House Dust Mite Allergic Rhinitis- ACARAY Study
A study testing Puressentiel Allergy Protection Nasal Spray and Saline spray (0.65%) in people with Allergic Disorder of Respiratory System, run by Puressentiel.
Trial summary
Justification of the relevance of the research: Patients suffering from allergic rhinitis are looking for several therapeutic options to control their symptoms. Although etiological treatment is based on allergen immunotherapy, and most prescribed symptomatic therapies include antihistamines and/or topical corticoids… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Disorder of Respiratory System
- What is being tested?
- Puressentiel Allergy Protection Nasal Spray and Saline spray (0.65%)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have given their express consent to participate in the study.
- The patient must be affiliated with or a beneficiary of a health insurance plan.
- The patient is at least 18 years of age.
- Patients who have already consulted the allergy department at Montpellier University Hospital.
- Patients suffering from perennial rhinitis (or rhino-conjunctivitis) caused by dust mites, diagnosed more than one year ago.
- In the case of asthmatic patients, asthma must be under control.
- Patients who have been able to stop all treatment with antihistamines or nasal corticosteroids for one week prior to the start of the study (7 days and 1 month, respectively).
- Patients covered by social security.
Who cannot join
- General exclusion criteria:
- The patient is in a period of exclusion determined by a previous study.
- The patient is under judicial protection, guardianship, or curatorship.
- The patient is a minor.
- The patient is not fluent in French.
- Exclusion criteria regarding interfering diseases or conditions:
Show all 13Show fewer
- The patient is pregnant and/or breastfeeding.
- Patient sensitized to a perennial allergen in addition to dust mites.
- Patient sensitized to a seasonal allergen, during the allergen's peak pollen season.
- Patient who has had a viral infection within 4 weeks prior to the provocation test.
- Patient treated or undergoing treatment with allergen immunotherapy.
- Patient treated with antihistamines (7-day washout period) or nasal corticosteroids (1-month washout period).
- Patients with severe uncontrolled asthma.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Justification of the relevance of the research:
Patients suffering from allergic rhinitis are looking for several therapeutic options to control their symptoms. Although etiological treatment is based on allergen immunotherapy, and most prescribed symptomatic therapies include antihistamines and/or topical corticoids, patients tend to self-medicate and seek different options, also choosing non-pharmacological approaches, particularly when symptoms are milder; nevertheless, accurate and reliable information on non-conventional therapies remains limited.
Read more
Main research hypothesis and objectives:
The present study, will prospectively investigate the potential role of Puressentiel® Protection Allergies nasal spray (SNPA) in patients suffering from house dust mite allergic rhinitis.
Assessment of the benefits and risks of the research, including the expected benefits for the people who undergo the research and the foreseeable risks associated with the research treatment and investigative procedures:
No individual benefit is expected. With regard to possible indirect benefits, this study could help to propose a natural, alternative solution to symptomatic medication for the symptoms of allergic rhinitis in mite-allergic patients. The main risks of this study are those linked to the performance of the nasal challenge test, i.e. the appearance of symptoms of allergic rhinitis.
Justification for the inclusion of persons covered by articles L.1121-5 to L.1121-8 and L.1122-1-2 of the French Public Health Code (e.g. minors, protected adults, etc.) and procedure implemented to inform and obtain the consent of these persons or their legal representatives.
Subjects over 18 years of age will be included in this project. People under court protection, guardianship or curatorship are excluded from this research.
Description of the recruitment process:
Patients are recruited at the time of consultation in the Division of Allergology, Department of Pneumology, Allergology and Thoracic Oncology, Hôpital Arnaud de Villeneuve - CHU de Montpellier, whatever the reason for the consultation (respiratory allergies, food allergies, drug allergies, skin allergies). Patients will be given a period of reflection before confirming their participation by signing an express consent form.
Investigation procedures carried out:
After a rhinitis and possibly asthma control test, patients will undergo a nasal mite challenge test, preceeded by the administration of either SPNA or placebo (saline solution)( D0). 15 days after the first test, a second test will be performed with the spray that was not administered on D0. Before, during and up to 4 hours after each nasal challenge test, the value of nasal inspiratory peak flow and a rhinitis score will be collected.
Justification of whether or not there is: (1) a prohibition on simultaneous participation in other research; (2) an exclusion period during which participation in other research is prohibited/ Given the need to stop anti-allergy treatments before and during the study; participation in another study is not permitted 7 days before the start of the present study and 7 days after its end (exclusion period).
Terms and amount of compensation for research participants Researchers will be compensated up to €500. Anticipated number of people to be included in the research 20 (twenty)
Read the detailed description
Main objective:
Testing the protective effect of SNPA on the nasal inflammatory allergic response in subjects with allergic rhinitis caused by dust mites.
The main objective of this clinical investigation is to evaluate the reduction in rhinoconjunctivitis symptoms following a nasal provocation test (Dermatophagoides pteronyssinus) performed after administration of Puressentiel Allergy Protection Nasal Spray, compared to those developed after administration of a placebo.
Secondary objectives
- Evaluate the difference in terms of nasal obstruction, measured by inspiratory nasal peak flow (INPF), after administration of the protective nasal spray and after placebo.
- Evaluate the duration of symptoms after performing the TPN and check whether there is a difference after the tests performed with the SPNA and with the placebo.
Méthodology
- 1 Type of study This is a prospective, single-center, crossover, randomized, double-blind, placebo-controlled study in adult subjects with allergic rhinitis caused by dust mites.
- 2 Main evaluation criteria The primary endpoint will be the difference between the validated symptom score for nasal provocation tests after performing the test with SPNA and with placebo.
- 3 Secondary evaluation criteria
- Difference between the value obtained with PFIN before TPN and after TPN and the difference between the results obtained when SPNA and placebo were administered beforehand.
- Difference between the duration of symptoms appearing after TPN with SPNA and with placebo
- 4 Scheduled visits and examinations
Two visits are planned, with at least 15 days (+7) between visits (washout period). During each of the two visits, patients will undergo a clinical assessment and nasal provocation tests. Before the tests begin, the clinical assessment will include:
- Rhinitis control test (ARCT) and asthma control test (ACT), if applicable;
- Nasal and conjunctival symptom score ;
- Nasal inspiratory peak flow (NIPF).
Each patient will receive two sprays per nostril of SPNA or placebo (saline solution), depending on randomization. Those who received SPNA during the visit on Day 0 will receive the placebo on Day 15, and vice versa. Thirty minutes after the administration of the spray, a nasal provocation test with Dermatophagoides pteronyssinus (LETI Pharma) will be performed according to the recommendations of the European Academy of Allergy and Clinical Immunology (EAACI).
For the nasal provocation test, the patient will be seated and at rest for 10 minutes before the start of the test. They will be informed about the test procedure, with particular emphasis on the fact that they must not breathe through their nose or sniff during the administration of the solutions. They will be warned of the various symptoms that may occur: tingling, sneezing, nasal discharge, and nasal congestion. The patient will be in apnea, with their mouth open. A spray of 0.3 HEP/ml will be administered into each nostril, followed by the placement of a nose clip, which will be removed after 10 minutes. A second dose of 3 HEP/ml will then be administered, following the same procedure as before. After 10 minutes, the nose clip will be removed. New assessments of nasal symptom scores and PFIN will be performed between the two doses of TPN, at the end of TPN, and 30, 60, 120, and 240 minutes after TPN.
- Conditions
- Allergic Disorder of Respiratory System
- Being tested
- Puressentiel Allergy Protection Nasal Spray, Saline spray (0.65%)
- Keywords
- Allergic Rhinitis, Dust mite, Nasal Challenge
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Puressentiel Allergy Protection Nasal SprayDevice
Crossover study after nasal provocation test (Dermatophagoides pteronyssinus)
Saline spray (0.65%)Device
Crossover study after nasal provocation test (Dermatophagoides pteronyssinus)
| Study group | Role | What they receive |
|---|---|---|
| Puressentiel Protection Allergies nasal spray (SNPA) | Active comparator | Each patient will receive two sprays per nostril of SPNA . Thirty minutes after administration of the sprays, a nasal provocation test with Dermatophagoides pteronyssinus (LETI Pharma) will be performed according to the recommendations of the European Academy of Allergy and Clinical Immunology (EAACI).
For the nasal provocation test, the patient will be seated and at rest for 10 minutes before the start of the test. The patient will be in apnea, with their mouth open. A spray of 0.3 HEP/ml will be administered into each nostril. Receives: Device: Puressentiel Allergy Protection Nasal Spray |
| Saline spray | Placebo comparator | Placebo Comparator: Saline spray Arm Description: Each patient will receive two sprays per nostril of placebo (saline solution). Thirty minutes after administration of the sprays, a nasal provocation test with Dermatophagoides pteronyssinus (LETI Pharma) will be performed according to the recommendations of the European Academy of Allergy and Clinical Immunology (EAACI). For the nasal provocation test, the patient will be seated and at rest for 10 minutes before the start of the test. The patient will be in apnea, with their mouth open. A spray of 0.3 HEP/ml will be administered into each nostril. Receives: Device: Saline spray (0.65%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergic Rhinitis Control Test (ARCT)
A nasal provocation test with Dermatophagoides pteronyssinus (LETI Pharma) will be performed according to the recommendations of the European Academy of Allergy and Clinical Immunology (EAACI) after which ARCT will be recorded;
Measured: ARCT will be recorded 30, 60, 120 and 240 minutes after the nasal provocation test
Secondary outcomes (2)
Nasal and conjunctival symptom score
Measured: Nasal and conjunctival symptom score will be recorded 30, 60, 120 and 240 min after the nasnal provocative test
Nasal Inspiratory Peak Flow
Measured: Nasal Inspiratory Peak Flow will be recorded, 30, 60, 120 and 240 min after the nasal provocative test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Nov 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Disorder of Respiratory SystemStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients will undergo a nasal mite challenge test, preceeded by the administration of either SPNA or placebo (saline solution)( D0). 15 days after the first test, they will perform a second test with the spray that was not administered on D0. Before, during and up to 4 hours after each nasal challenge test, the value of nasal inspiratory peak flow and a rhinitis score will be collected.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Puressentiel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pascal Demoly, MD,PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196527
- Sponsor's protocol ID
- CPP lDF 6 : 24.05823.000403
- Acronym
- ACARAY
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Efficacy of PURESSENTIEL Allergy Protection Nasal Spray (SNPA®) in House Dust Mite Allergic Rhinitis- ACARAY Study
- ClinicalTrials.gov ID
- NCT07196527
- Acronym / sponsor ID
- ACARAY / CPP lDF 6 : 24.05823.000403
- Conditions
- Allergic Disorder of Respiratory System
- Keywords
- Allergic Rhinitis, Dust mite, Nasal Challenge
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- PuressentielIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 29 Sep 2025 (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.
Justification of the relevance of the research:
Patients suffering from allergic rhinitis are looking for several therapeutic options to control their symptoms. Although etiological treatment is based on allergen immunotherapy, and most prescribed symptomatic therapies include antihistamines and/or topical corticoids, patients tend to self-medicate and seek different options, also choosing non-pharmacological approaches, particularly when symptoms are milder; nevertheless, accurate and reliable information on non-conventional therapies remains limited.
Main research hypothesis and objectives:
The present study, will prospectively investigate the potential role of Puressentiel® Protection Allergies nasal spray (SNPA) in patients suffering from house dust mite allergic rhinitis.
Assessment of the benefits and risks of the research, including the expected benefits for the people who undergo the research and the foreseeable risks associated with the research treatment and investigative procedures:
No individual benefit is expected. With regard to possible indirect benefits, this study could help to propose a natural, alternative solution to symptomatic medication for the symptoms of allergic rhinitis in mite-allergic patients. The main risks of this study are those linked to the performance of the nasal challenge test, i.e. the appearance of symptoms of allergic rhinitis.
Justification for the inclusion of persons covered by articles L.1121-5 to L.1121-8 and L.1122-1-2 of the French Public Health Code (e.g. minors, protected adults, etc.) and procedure implemented to inform and obtain the consent of these persons or their legal representatives.
Subjects over 18 years of age will be included in this project. People under court protection, guardianship or curatorship are excluded from this research.
Description of the recruitment process:
Patients are recruited at the time of consultation in the Division of Allergology, Department of Pneumology, Allergology and Thoracic Oncology, Hôpital Arnaud de Villeneuve - CHU de Montpellier, whatever the reason for the consultation (respiratory allergies, food allergies, drug allergies, skin allergies). Patients will be given a period of reflection before confirming their participation by signing an express consent form.
Investigation procedures carried out:
After a rhinitis and possibly asthma control test, patients will undergo a nasal mite challenge test, preceeded by the administration of either SPNA or placebo (saline solution)( D0). 15 days after the first test, a second test will be performed with the spray that was not administered on D0. Before, during and up to 4 hours after each nasal challenge test, the value of nasal inspiratory peak flow and a rhinitis score will be collected.
Justification of whether or not there is: (1) a prohibition on simultaneous participation in other research; (2) an exclusion period during which participation in other research is prohibited/ Given the need to stop anti-allergy treatments before and during the study; participation in another study is not permitted 7 days before the start of the present study and 7 days after its end (exclusion period).
Terms and amount of compensation for research participants Researchers will be compensated up to €500. Anticipated number of people to be included in the research 20 (twenty)
Detailed description
Main objective:
Testing the protective effect of SNPA on the nasal inflammatory allergic response in subjects with allergic rhinitis caused by dust mites.
The main objective of this clinical investigation is to evaluate the reduction in rhinoconjunctivitis symptoms following a nasal provocation test (Dermatophagoides pteronyssinus) performed after administration of Puressentiel Allergy Protection Nasal Spray, compared to those developed after administration of a placebo.
Secondary objectives
- Evaluate the difference in terms of nasal obstruction, measured by inspiratory nasal peak flow (INPF), after administration of the protective nasal spray and after placebo.
- Evaluate the duration of symptoms after performing the TPN and check whether there is a difference after the tests performed with the SPNA and with the placebo.
Méthodology
- 1 Type of study This is a prospective, single-center, crossover, randomized, double-blind, placebo-controlled study in adult subjects with allergic rhinitis caused by dust mites.
- 2 Main evaluation criteria The primary endpoint will be the difference between the validated symptom score for nasal provocation tests after performing the test with SPNA and with placebo.
- 3 Secondary evaluation criteria
- Difference between the value obtained with PFIN before TPN and after TPN and the difference between the results obtained when SPNA and placebo were administered beforehand.
- Difference between the duration of symptoms appearing after TPN with SPNA and with placebo
- 4 Scheduled visits and examinations
Two visits are planned, with at least 15 days (+7) between visits (washout period). During each of the two visits, patients will undergo a clinical assessment and nasal provocation tests. Before the tests begin, the clinical assessment will include:
- Rhinitis control test (ARCT) and asthma control test (ACT), if applicable;
- Nasal and conjunctival symptom score ;
- Nasal inspiratory peak flow (NIPF).
Each patient will receive two sprays per nostril of SPNA or placebo (saline solution), depending on randomization. Those who received SPNA during the visit on Day 0 will receive the placebo on Day 15, and vice versa. Thirty minutes after the administration of the spray, a nasal provocation test with Dermatophagoides pteronyssinus (LETI Pharma) will be performed according to the recommendations of the European Academy of Allergy and Clinical Immunology (EAACI).
For the nasal provocation test, the patient will be seated and at rest for 10 minutes before the start of the test. They will be informed about the test procedure, with particular emphasis on the fact that they must not breathe through their nose or sniff during the administration of the solutions. They will be warned of the various symptoms that may occur: tingling, sneezing, nasal discharge, and nasal congestion. The patient will be in apnea, with their mouth open. A spray of 0.3 HEP/ml will be administered into each nostril, followed by the placement of a nose clip, which will be removed after 10 minutes. A second dose of 3 HEP/ml will then be administered, following the same procedure as before. After 10 minutes, the nose clip will be removed. New assessments of nasal symptom scores and PFIN will be performed between the two doses of TPN, at the end of TPN, and 30, 60, 120, and 240 minutes after TPN.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients will undergo a nasal mite challenge test, preceeded by the administration of either SPNA or placebo (saline solution)( D0). 15 days after the first test, they will perform a second test with the spray that was not administered on D0. Before, during and up to 4 hours after each nasal challenge test, the value of nasal inspiratory peak flow and a rhinitis score will be collected.
| Arm | Type | Receives |
|---|---|---|
| Puressentiel Protection Allergies nasal spray (SNPA) | Active comparator | Device: Puressentiel Allergy Protection Nasal SprayEach patient will receive two sprays per nostril of SPNA . Thirty minutes after administration of the sprays, a nasal provocation test with Dermatophagoides pteronyssinus (LETI Pharma) will be performed according to the recommendations of the European Academy of Allergy and Clinical Immunology (EAACI). For the nasal provocation test, the patient will be seated and at rest for 10 minutes before the start of the test. The patient will be in apnea, with their mouth open. A spray of 0.3 HEP/ml will be administered into each nostril. |
| Saline spray | Placebo comparator | Device: Saline spray (0.65%)Placebo Comparator: Saline spray Arm Description: Each patient will receive two sprays per nostril of placebo (saline solution). Thirty minutes after administration of the sprays, a nasal provocation test with Dermatophagoides pteronyssinus (LETI Pharma) will be performed according to the recommendations of the European Academy of Allergy and Clinical Immunology (EAACI). For the nasal provocation test, the patient will be seated and at rest for 10 minutes before the start of the test. The patient will be in apnea, with their mouth open. A spray of 0.3 HEP/ml will be administered into each nostril. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient must have given their express consent to participate in the study.
- The patient must be affiliated with or a beneficiary of a health insurance plan.
- The patient is at least 18 years of age.
- Patients who have already consulted the allergy department at Montpellier University Hospital.
- Patients suffering from perennial rhinitis (or rhino-conjunctivitis) caused by dust mites, diagnosed more than one year ago.
Key exclusion criteria (13 listed)
- The patient is in a period of exclusion determined by a previous study.
- The patient is under judicial protection, guardianship, or curatorship.
- The patient is a minor.
- The patient is not fluent in French.
- The patient is pregnant and/or breastfeeding.
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 |
|---|---|---|
| Puressentiel Allergy Protection Nasal SprayCrossover study after nasal provocation test (Dermatophagoides pteronyssinus) | Device | Puressentiel Protection Allergies nasal spray (SNPA) |
| Saline spray (0.65%)Crossover study after nasal provocation test (Dermatophagoides pteronyssinus) | Device | Saline spray |
Primary outcome
Allergic Rhinitis Control Test (ARCT)
Time frame: ARCT will be recorded 30, 60, 120 and 240 minutes after the nasal provocation test
A nasal provocation test with Dermatophagoides pteronyssinus (LETI Pharma) will be performed according to the recommendations of the European Academy of Allergy and Clinical Immunology (EAACI) after which ARCT will be recorded;
2 secondary outcomes
Nasal and conjunctival symptom score
Time frame: Nasal and conjunctival symptom score will be recorded 30, 60, 120 and 240 min after the nasnal provocative test
Nasal Inspiratory Peak Flow
Time frame: Nasal Inspiratory Peak Flow will be recorded, 30, 60, 120 and 240 min after the nasal provocative test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: Undecided
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.
Pascal Demoly, MD,PhD principal investigator
University Hospital, Montpellier
Questions about this trial
What is this clinical trial studying?
A study testing Puressentiel Allergy Protection Nasal Spray and Saline spray (0.65%) in people with Allergic Disorder of Respiratory System, run by Puressentiel.
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 8 inclusion and 13 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: opening soon, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pascal Demoly, MD, PhD (+33467336127, pascal.demoly@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Allergic Rhinitis Control Test (ARCT) (time frame: ARCT will be recorded 30, 60, 120 and 240 minutes after the nasal provocation test). 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 29 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.