Seawater nasal spray with essential oils for short-term relief of blocked nose from acute rhinitis
Prospective Multicenter Clinical Investigation to Evaluate the Performance and the Safety of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert (DEMECA)
This test will try a seawater nasal spray enriched with essential oils in people aged 12 and older who have a blocked nose from acute rhinitis to see if it improves symptoms over 7 days.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 114 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Laboratoires Gilbert Industry-sponsored |
| Locations | 3 sites (Bayeux and 2 other locations) |
| Trial ID | NCT06580210 on ClinicalTrials.gov |
What this trial studies
This is a post-market observational investigation of a mechanical decongestant seawater nasal spray enriched with essential oils, conducted over a seven-day period. Patients aged 12 and older with acute rhinitis and nasal obstruction from infectious or allergic causes will use the marketed spray and complete questionnaires on symptoms and tolerability. No experimental drugs are given; outcomes and any adverse events are collected in a real-world pharmacy setting at participating sites. Safety monitoring focuses on reported side effects and contraindications such as known hypersensitivity to the product ingredients.
Who should consider this trial
Good fit: People aged 12 or older with acute rhinitis and nasal obstruction who can consent (or assent with guardian consent), are affiliated with social security, can complete study questionnaires, and have no known allergy to the spray ingredients are ideal candidates.
Not a fit: Patients with respiratory insufficiency, nasal deformities or polyps, a history of febrile convulsions in children, or known hypersensitivity to seawater or any spray ingredient are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, the spray could offer a well-tolerated, non-drug option for short-term relief of nasal congestion in acute rhinitis.
How similar studies have performed: Saline nasal sprays and irrigation have prior evidence for symptom relief in rhinitis, but seawater sprays enriched with essential oils have limited clinical data and few formal post-market studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Patient ≥ 12 years, * 2\. Patient with acute rhinitis associated with nasal obstruction during infectious episodes such as rhynopharyngitis (cold), rhinosinusitis, or during non-infectious episodes as allergic rhinitis, * 3\. a. Informed adult patient who has given written consent prior to any study specific procedure, * b. Informed minor patients 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 (questionnaire completion), * 5\. Patient affiliated to a social security scheme. Exclusion Criteria: * 1\. Patient who does not want to participate to the clinical investigation, * 2\. Hypersensitivity to seawater and/or known allergies to any of the ingredients of the spray, * 3\. A child with a history of febrile convulsions, * 4\. Diseases leading to respiratory insufficiency, * 5\. Patient suffering from nasal deformity or nasal polyps leading to chronic nasal obstruction, * 6\. Patient on local ans systemic vasoconstrictors, local and systemic corticosteroids and antihistamines, non-steroidal anti-inflammatory (NSAIDs), antibiotics and local antiseptics, * 7\. Concomitant use of other nasal sprays, essential oils for local nasal use and nsal cream or gel, * 8\. Patient under guardianship, curatorship of safeguard of justice.
Where this trial is running
Bayeux and 2 other locations
- Pharmacie du Pont Saint Jean — Bayeux, France (Not_yet_recruiting)
- Pharmacie de la Guérinière — Caen, France (Recruiting)
- Pharmacie de la Force — La Force, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Léa RADDAY
- Email: lradday@labogilbert.fr
- Phone: +33 (0)2 31 47 16 61
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.