An interventional study of Puressentiel Allergy Protection Nasal Spray and Saline spray (0.65%) in Allergic Disorder of Respiratory System, sponsored by Puressentiel. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-29.
Sponsored by Puressentiel · Not applicable, Interventional, and Prevention
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)
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
Méthodology
3 Secondary evaluation criteria
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:
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.
717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.
This study's planned enrollment of 20 is below the median of 68 across 552 interventional studies indexed under Rhinitis, Allergic.
Browse Rhinitis, Allergic studies →Puressentiel is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:General inclusion criteria:
Inclusion criteria for the target population:
Exclusion Criteria:5.4 Exclusion Criteria
General exclusion criteria:
Exclusion criteria regarding interfering diseases or conditions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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%)
Crossover study after nasal provocation test (Dermatophagoides pteronyssinus)
Crossover study after nasal provocation test (Dermatophagoides pteronyssinus)
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;
Time frame: ARCT will be recorded 30, 60, 120 and 240 minutes after the nasal provocation test
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
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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