Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms
SeaBridge
Real-word Study to Assess Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms
1 other identifier
interventional
1,065
1 country
32
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2025
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 27, 2025
CompletedFirst Submitted
Initial submission to the registry
November 20, 2025
CompletedFirst Posted
Study publicly available on registry
December 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
December 3, 2025
November 1, 2025
11 months
November 20, 2025
December 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Real-life effectiveness to improve nasal symptoms in case of acute and chronic sinonasal pathologies.
Change from baseline in nasal symptom intensity following initiation of nasal wash, based on the modified SNOT-22 rhinologic score. 6-modalities intensity Likert scale: 0=No problem; 1= Very mild problem; 2=Mild or slight problem; 3= Moderate problem; 4=Severe problem; 5=Problem as bad as it can be.
From Day 0 to Day 5 (acute indications: URTI, COVID-19, bronchiolitis) From Day 0 to Day 14 (chronic indications: allergic rhinitis, chronic rhinosinusitis, post-surgery)
Secondary Outcomes (83)
Real-life effectiveness to reduce the intensity of individuals symptoms
From Day 0 to Day 14
Real-life effectiveness to reduce the intensity of additional extra nasal symptoms
From Day 0 to Day 14
Real-life effectiveness to reduce the intensity of eyes symptoms
From Day 0 to Day 14
Real-life effectiveness to reduce the daily intensity of symptoms
From Day 0 to Day 14
Real-life effectiveness to reduce the overall intensity of symptoms
From Day 0 to Day 14
- +78 more secondary outcomes
Study Arms (4)
Respimer® Hygiene-Prevention - Baby, kids, adults
OTHERRespimer® Hygiene-Prevention - Baby, kids, adults - Lavage nasal Babies from 15 days, children \& adults URTI; Bronchiolitis; Allergic rhinitis
Respimer® Hygiene-Prevention - Kids, adults
OTHERRespimer® Hygiene-Prevention Kids, Adults -Nasal wash Children from 2 years \& adults URTI; COVID-19; Allergic rhinitis; Chronic rhinosinusitis; Post-surgery
Respimer® Decongestion -Baby, kids, adults
OTHERRespimer® Decongestion Baby, kids, adults - Nasal wash Babies from 2 months, children \& adults URTI ; Allergic rhinitis; Chronic rhinosinusitis
Phytosun arôms® Hypertonic nasal wash - Children & adults
OTHERPhytosun arôms® Hypertonic nasal wash Children from 6 years \& adults URTI
Interventions
1 second spray in each nostril, 2-3 times a day.
1-3 seconds spray in each nostril, * 4 to 6 times a day, in treatment of nasal symptoms. * 1 to 2 times a day, in hygiene and prevention
1-2 seconds spray in each nostril, * 4 to 6 times a day, in treatment of nasal symptoms * 1 to 2 times a day, in hygiene and prevention
Baby (2 months+): 1-3 seconds spray in each nostril, up to 3 times a day Children (2 y+) and adults: 1-3 seconds spray in each nostril, up to 6 times a day
Eligibility Criteria
You may qualify if:
- 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).
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laboratoire de la Merlead
- EVAMEDcollaborator
Study Sites (32)
CHU Bordeaux
Bordeaux, France
Pharmacie de la Faïncerie
Bourg-la-Reine, France
Pharmacie Marine
Cabourg, France
Pharmacie Daguet
Châteauroux, France
Pharmacie des verts coteaux
Châtenay-Malabry, France
Pharmacie Lombard
Châtenay-Malabry, France
Maison Médicale Avicenne
Chevaigné, France
CHU de Clermont-Ferrand
Clermont-Ferrand, France
Kap Santé
Courrières, France
Pharmacie de la Liberté
Falaise, France
Maison médicale Heyrieux
Heyrieux, France
CHD Vendée
La Roche-sur-Yon, France
CKRF Marcq en Baroeul
Marcq-en-Barœul, France
Centre de Kinésithérapie spécialisé en rééducation respiratoire - Marseille
Marseille, France
La Maison du Souffle
Metz, France
Centre médical Chamberte
Montpellier, France
CHU Poitiers
Poitiers, France
Pharmacie du Pot d'Etain
Pont-Audemer, France
Pharmacie DRAPEAU
Pont-Saint-Martin, France
Cabinet de kinésithérapie respiratoire Sophie Jacques
Rennes, France
Pharmacie Deroche
Roézé-sur-Sarthe, France
Pharmacie Girard
Saint-Colomban, France
Clinique Saint-Jean
Saint-Jean-de-Védas, France
Centre de santé respiratoire Saint Paul Lès Dax
Saint-Paul-lès-Dax, France
Pharmacie des Corsaires
St-Malo, France
Pôle Santé de Réadaptation Toulouse Ouest
Toulouse, France
CRKF Tourcoing
Tourcoing, France
Maison médicale Belencontre
Tourcoing, France
Maison médicale de la Bourgogne
Tourcoing, France
Centre respiratoire de Valenciennes
Valenciennes, France
Cabinet de Kinésithérapie HODOROABA Vincent
Wissous, France
Pharmacie St-Exupery
Wissous, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2025
First Posted
December 3, 2025
Study Start
August 27, 2025
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
December 3, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share