Evaluation of the Clinical Efficacy of PURESSENTIEL Allergy Protection Nasal Spray (SNPA®) in House Dust Mite Allergic Rhinitis- ACARAY Study

NCT07196527 | Not Yet Recruiting

• 1 other identifier: CPP lDF 6 : 24.05823.000403
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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, 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)

Conditions

Allergic Disorder of Respiratory System

Keywords

Allergic Rhinitis; Dust mite; Nasal Challenge

Outcome Measures

Primary Outcomes (1)

• 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;

  ARCT will be recorded 30, 60, 120 and 240 minutes after the nasal provocation test

Secondary Outcomes (2)

• Nasal and conjunctival symptom score

  Nasal and conjunctival symptom score will be recorded 30, 60, 120 and 240 min after the nasnal provocative test

• Nasal Inspiratory Peak Flow

  Nasal Inspiratory Peak Flow will be recorded, 30, 60, 120 and 240 min after the nasal provocative test

Study Arms (2)

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.

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.

Device: Saline spray (0.65%)

Interventions

Puressentiel Allergy Protection Nasal Spray DEVICE

Crossover study after nasal provocation test (Dermatophagoides pteronyssinus)

Puressentiel Protection Allergies nasal spray (SNPA)

Saline spray (0.65%) DEVICE

Crossover study after nasal provocation test (Dermatophagoides pteronyssinus)

Saline spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Puressentiel: lead

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Pascal Demoly, MD,PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal Demoly, MD, PhD

CONTACT

+33467336127; pascal.demoly@inserm.fr

Davide CAIMMI, MD, PhD

CONTACT

+33467336112; dp-caimmi@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 29, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09