NCT05494346 Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"
| NCT ID | NCT05494346 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Laboratoires Gilbert |
| Condition | Acute Rhinitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 101 participants |
| Start Date | 2023-06-23 |
| Primary Completion | 2026-04-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 101 participants in total. It began in 2023-06-23 with a primary completion date of 2026-04-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this pre-market clinical investigation is to assess the safety and the performance of decongestant seawater spray pocket valve enriched with essential oils by Gilbert Laboratories. The study will evaluate the results of acute rhinitis associated with nasal obstruction using the decongestant seawaterspray pocket valve enriched with essential oils over a 8 day period.
Eligibility Criteria
Inclusion Criteria: * 1\. Patient ≥ 12 years. * 2\. Patient with acute rhinitis associated with nasal obstruction during infectious episodes such as rhinopharyngitis (cold), rhinosinusitis, or during non-infectious episodes such as allergic rhinitis. * 3\. a. Informed adult patient who has given written consent prior to any study specific procedure. b. Informed minor patient who has given assent and whose legal guardians have given written consent prior to any study-specific procedure. * 4\. Patient able to meet the study requirements for monitoring, spray use, and questionnaire completion. * 5\. Patient affiliated to a social security scheme. Exclusion Criteria: * 1\. Pregnant and/or breastfeeding woman * 2\. Hypersensitivity to seawater and/or known allergies to any of the ingredients of the spray. * 3\. Diseases causing narrowing of the airways (e.g. asthma, chronic obstructive pulmonary disease (COPD)) and/or respiratory insufficiency. * 4\. Patients with uncontrolled asthma (GINA score greater than or equal to 4) * 5\. Patients undergoing allergy desensitization * 6\. Patients suffering from chronic nasal obstruction due to a deformation of the nasal wall or nasal polyps. creams or gels. * 7\. Patients taking local and systemic vasoconstrictors, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), antibiotics, and local antiseptics. * 8\. Concomitant use of other nasal sprays, essential oils for local nasal use, creams, or gels for the nose. * 9\. Patients under guardianship, conservatorship, or legal protection.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05494346 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Acute Rhinitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05494346 currently recruiting?
Yes, NCT05494346 is actively recruiting participants. Contact the research team at cbrunel@labogilbert.fr for enrollment information.
Where is the NCT05494346 trial being conducted?
This trial is being conducted at Blainville-sur-Orne, France, Caen, France, Châteauneuf-sur-Sarthe, France, Gainneville, France and 1 additional location.
Who is sponsoring the NCT05494346 clinical trial?
NCT05494346 is sponsored by Laboratoires Gilbert. The trial plans to enroll 101 participants.