Assessment of a decongestant seawater spray with essential oils for nasal obstruction
Prospective Multicenter Clinical Investigation Evaluating the Performance and Safety of Gilbert Laboratories' Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils
This study is testing a new seawater spray with essential oils to see if it helps people aged 12 and older who have nasal congestion from colds or allergies breathe easier.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 101 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Laboratoires Gilbert Industry-sponsored |
| Locations | 5 sites (Blainville-sur-Orne and 4 other locations) |
| Trial ID | NCT05494346 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to evaluate the safety and performance of a decongestant seawater spray enriched with essential oils in patients suffering from acute rhinitis associated with nasal obstruction. Over an 8-day period, participants will use the spray, and their peak nasal flow will be measured to assess the effectiveness of the treatment. The study includes patients aged 12 and older who experience nasal obstruction due to various conditions, including infections and allergies. The results will help determine the potential benefits of this novel treatment approach.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 12 and older with acute rhinitis associated with nasal obstruction.
Not a fit: Patients with chronic nasal obstruction or respiratory diseases like asthma or COPD may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide relief for patients suffering from nasal obstruction due to acute rhinitis.
How similar studies have performed: While similar approaches have been explored, this specific formulation and method of delivery may offer novel insights into treatment efficacy.
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 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.
Where this trial is running
Blainville-sur-Orne and 4 other locations
- Cabinet Médical — Blainville-sur-Orne, France (Recruiting)
- Cabinet Médical Caen — Caen, France (Recruiting)
- MSP du Haut Anjou — Châteauneuf-sur-Sarthe, France (Recruiting)
- Cabinet Médical Gainneville — Gainneville, France (Withdrawn)
- Alyatec — Strasbourg, France (Completed)
Study contacts
- Study coordinator: Carine BRUNEL
- Email: cbrunel@labogilbert.fr
- Phone: +33 (0)1 45 39 50 21
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.