NCT07262450Recruiting
Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms
Real-word Study to Assess Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms
Source: ClinicalTrials.gov · Last updated 3 Dec 2025
Brief summary (registry, in English)
The purpose of this post-market clinical investigation is to assess in a real-life setting, the effectiveness, usage, tolerance, safety and satisfaction of 4 isotonic and hypertonic seawater-based CE-marked nasal sprays. The main questions it aims to answer are: * Efficacy, * Safety, * Usage, * Satisfaction, in real-life usage among infants, children, adults and pregnant or breastfeeding women suffering from acute and chronic sinonasal pathologies. The 4 medical devices under investigation will be used in accordance with their intended use, target populations and medical indications.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1065 (estimated)
- First submitted
- 20 Nov 2025
- Start date
- 27 Aug 2025
- Primary completion date
- Aug 2026
- Lead sponsor
- Laboratoire de la Mer
- NCT number
- NCT07262450
What you commit to
- Study type: Interventional
- Planned participants: 1065
- From 27 Aug 2025 to the primary completion date, Aug 2026
- 32 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Subject's age and medical condition in compliance with the intended use and population
- Subjects who, from the investigator's judgement, should benefit from nasal wash in accordance with routine medical practice
- Subjects with at least two nasal symptoms of intensity ≥ 3 (6 modalities intensity SNOT-22 rating-scale) among the following:
- Nasal blockage/nasal congestion/ stuffy nose;
- Runny nose;
- Need to blow/clear the nose;
- Sneezing;
- Thick nasal discharge/secretions;
- Decreased sense of smell /taste (replaced by "noisy breathing/mouth breathing" for infants)
- Subjects with impaired nasal breathing (score ≥ 3, 6-modalities intensity rating-scale), induced by the presence of nasal symptoms
- For acute indications (only): subjects with symptoms started not later than 72 hours prior to enrolment (Day 0).
- For allergic rhinitis indication: perennial allergic rhinitis with and without seasonal allergic rhinitis
- For post-surgery indication: septoplasty and rhinoseptoplasty.
- Subject/parent willing to perform nasal wash following advices received from HCPs.
- Subjects (or parents for babies and children) agreeing to follow the study requirements during the whole study period (up to 3 months).
- Subject (or parent for baby and children) able to understand verbal and written local language and in capacity to fill-in questionnaire by himself.
- Subject having daily access to internet to answer online questionnaire.
- Subject or Parent/legal guardian of the subject has given freely and expressly her/his informed consent.
- Subject affiliated to the health social security system or beneficiary of an equivalent system
- Non-inclusion criteria:
- Subject with contraindications according to each IFU.
- Hypersensitivity or known allergy to any component of the investigational products.
- Subject taking part in another clinical study or being in the exclusion period of another clinical study.
- Subject already using nasal wash to manage his nasal symptoms.
- Subject already included once in the study.
- Subject with a member of his household already included in the study if still in the follow-up phase.
- Subject deprived of liberty by administrative or judicial decision or under legal guardianship.
Age in the registry: 15 days to - · Sex: All · Does not accept healthy volunteers
Sites (32)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Pharmacie de la Faïncerie Coordinator of this site? Confirm its status | Bourg-la-Reine | France | Recruiting |
| Pharmacie Marine Coordinator of this site? Confirm its status | Cabourg | France | Recruiting |
| Pharmacie Daguet Coordinator of this site? Confirm its status | Châteauroux | France | Recruiting |
| Pharmacie Lombard Coordinator of this site? Confirm its status | Châtenay-Malabry | France | Recruiting |
| Pharmacie des verts coteaux Coordinator of this site? Confirm its status | Châtenay-Malabry | France | Recruiting |
| Maison Médicale Avicenne Coordinator of this site? Confirm its status | Chevaigné | France | Recruiting |
| CHU de Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Kap Santé Coordinator of this site? Confirm its status | Courrières | France | Recruiting |
| Pharmacie de la Liberté Coordinator of this site? Confirm its status | Falaise | France | Recruiting |
| Maison médicale Heyrieux Coordinator of this site? Confirm its status | Heyrieux | France | Recruiting |
| CHD Vendée Coordinator of this site? Confirm its status | La Roche-sur-Yon | France | Recruiting |
| CKRF Marcq en Baroeul Coordinator of this site? Confirm its status | Marcq-en-Barœul | France | Recruiting |
| Centre de Kinésithérapie spécialisé en rééducation respiratoire - Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| La Maison du Souffle Coordinator of this site? Confirm its status | Metz | France | Recruiting |
| Centre médical Chamberte Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| CHU Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| Pharmacie du Pot d'Etain Coordinator of this site? Confirm its status | Pont-Audemer | France | Recruiting |
| Pharmacie DRAPEAU Coordinator of this site? Confirm its status | Pont-Saint-Martin | France | Recruiting |
| Cabinet de kinésithérapie respiratoire Sophie Jacques Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| Pharmacie Deroche Coordinator of this site? Confirm its status | Roézé-sur-Sarthe | France | Recruiting |
| Pharmacie Girard Coordinator of this site? Confirm its status | Saint-Colomban | France | Recruiting |
| Clinique Saint-Jean Coordinator of this site? Confirm its status | Saint-Jean-de-Védas | France | Recruiting |
| Centre de santé respiratoire Saint Paul Lès Dax Coordinator of this site? Confirm its status | Saint-Paul-lès-Dax | France | Recruiting |
| Pharmacie des Corsaires Coordinator of this site? Confirm its status | St-Malo | France | Recruiting |
| Pôle Santé de Réadaptation Toulouse Ouest Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| CRKF Tourcoing Coordinator of this site? Confirm its status | Tourcoing | France | Recruiting |
| Maison médicale de la Bourgogne Coordinator of this site? Confirm its status | Tourcoing | France | Recruiting |
| Maison médicale Belencontre Coordinator of this site? Confirm its status | Tourcoing | France | Recruiting |
| Centre respiratoire de Valenciennes Coordinator of this site? Confirm its status | Valenciennes | France | Recruiting |
| Pharmacie St-Exupery Coordinator of this site? Confirm its status | Wissous | France | Recruiting |
| Cabinet de Kinésithérapie HODOROABA Vincent Coordinator of this site? Confirm its status | Wissous | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.