Status:
NOT_YET_RECRUITING
Evaluation of the Clinical Efficacy of PURESSENTIEL Allergy Protection Nasal Spray (SNPA®) in House Dust Mite Allergic Rhinitis- ACARAY Study
Lead Sponsor:
Puressentiel
Conditions:
Allergic Disorder of Respiratory System
Eligibility:
All Genders
18+ years
Phase:
NA
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 base...
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 investi...
Eligibility Criteria
Inclusion
- General inclusion criteria:
- 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.
- Inclusion criteria for the target population:
- 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.
Exclusion
- 4 Exclusion Criteria
- 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:
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07196527
Start Date
November 1 2025
End Date
February 1 2027
Last Update
September 29 2025
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