Actively Recruiting
Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms
Led by Laboratoire de la Mer · Updated on 2025-12-03
1065
Participants Needed
32
Research Sites
48 weeks
Total Duration
On this page
Sponsors
L
Laboratoire de la Mer
Lead Sponsor
E
EVAMED
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject's age and medical condition align with intended use and population
- Investigator judges the subject should benefit from nasal wash per routine medical practice
- Subject has at least two nasal symptoms with intensity 63 3 on a 6-point scale, including nasal blockage, runny nose, need to clear nose, sneezing, thick nasal discharge, or decreased smell/taste (or noisy breathing for infants)
- Subject has impaired nasal breathing with a score 63 3 due to nasal symptoms
- For acute conditions: symptoms started within 72 hours before enrollment
- For allergic rhinitis: includes perennial with or without seasonal allergic rhinitis
- For post-surgery: includes septoplasty and rhinoseptoplasty
- Subject or parent willing to perform nasal wash as advised
- Subject or parent agrees to follow study requirements for up to 3 months
- Subject or parent can understand local language and complete questionnaire independently
- Subject has daily internet access to answer online questionnaire
- Subject or parent/legal guardian has given informed consent
- Subject is affiliated with health social security or equivalent system
You will not qualify if you...
- Subject has contraindications per product instructions for use
- Known allergy or hypersensitivity to any product component
- Currently participating in another clinical study or within exclusion period
- Already using nasal wash for nasal symptoms
- Previously included once in this study
- Household member already included and still in follow-up
- Subject deprived of liberty by legal or administrative decision or under legal guardianship
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 32 locations
1
CHU Bordeaux
Bordeaux, France
Actively Recruiting
2
Pharmacie de la Faïncerie
Bourg-la-Reine, France
Actively Recruiting
3
Pharmacie Marine
Cabourg, France
Actively Recruiting
4
Pharmacie Daguet
Châteauroux, France
Actively Recruiting
5
Pharmacie des verts coteaux
Châtenay-Malabry, France
Actively Recruiting
6
Pharmacie Lombard
Châtenay-Malabry, France
Actively Recruiting
7
Maison Médicale Avicenne
Chevaigné, France
Actively Recruiting
8
CHU de Clermont-Ferrand
Clermont-Ferrand, France
Actively Recruiting
9
Kap Santé
Courrières, France
Actively Recruiting
10
Pharmacie de la Liberté
Falaise, France
Actively Recruiting
11
Maison médicale Heyrieux
Heyrieux, France
Actively Recruiting
12
CHD Vendée
La Roche-sur-Yon, France
Actively Recruiting
13
CKRF Marcq en Baroeul
Marcq-en-Barœul, France
Actively Recruiting
14
Centre de Kinésithérapie spécialisé en rééducation respiratoire - Marseille
Marseille, France
Actively Recruiting
15
La Maison du Souffle
Metz, France
Actively Recruiting
16
Centre médical Chamberte
Montpellier, France
Actively Recruiting
17
CHU Poitiers
Poitiers, France
Actively Recruiting
18
Pharmacie du Pot d'Etain
Pont-Audemer, France
Actively Recruiting
19
Pharmacie DRAPEAU
Pont-Saint-Martin, France
Actively Recruiting
20
Cabinet de kinésithérapie respiratoire Sophie Jacques
Rennes, France
Actively Recruiting
21
Pharmacie Deroche
Roézé-sur-Sarthe, France
Actively Recruiting
22
Pharmacie Girard
Saint-Colomban, France
Actively Recruiting
23
Clinique Saint-Jean
Saint-Jean-de-Védas, France
Actively Recruiting
24
Centre de santé respiratoire Saint Paul Lès Dax
Saint-Paul-lès-Dax, France
Actively Recruiting
25
Pharmacie des Corsaires
St-Malo, France
Actively Recruiting
26
Pôle Santé de Réadaptation Toulouse Ouest
Toulouse, France
Actively Recruiting
27
CRKF Tourcoing
Tourcoing, France
Actively Recruiting
28
Maison médicale Belencontre
Tourcoing, France
Actively Recruiting
29
Maison médicale de la Bourgogne
Tourcoing, France
Actively Recruiting
30
Centre respiratoire de Valenciennes
Valenciennes, France
Actively Recruiting
31
Cabinet de Kinésithérapie HODOROABA Vincent
Wissous, France
Actively Recruiting
32
Pharmacie St-Exupery
Wissous, France
Actively Recruiting
Research Team
G
Gaëlle NAELTEN, PharmD / PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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