Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms
NCT ID: NCT07262450
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1065 participants
INTERVENTIONAL
2025-08-27
2026-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Respimer® Hygiene-Prevention - Baby, kids, adults
Respimer® Hygiene-Prevention - Baby, kids, adults - Lavage nasal Babies from 15 days, children \& adults URTI; Bronchiolitis; Allergic rhinitis
Respimer® Hygiene-Prevention -Baby, kids, adults
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
Respimer® Hygiene-Prevention - Kids, adults
Respimer® Hygiene-Prevention Kids, Adults -Nasal wash Children from 2 years \& adults URTI; COVID-19; Allergic rhinitis; Chronic rhinosinusitis; Post-surgery
Respimer® Hygiene-Prevention Kids, adults
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
Respimer® Decongestion -Baby, kids, adults
Respimer® Decongestion Baby, kids, adults - Nasal wash Babies from 2 months, children \& adults URTI ; Allergic rhinitis; Chronic rhinosinusitis
Respimer® Decongestion Baby, kids, adults
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
Phytosun arôms® Hypertonic nasal wash - Children & adults
Phytosun arôms® Hypertonic nasal wash Children from 6 years \& adults URTI
Phytosun arôms® Hypertonic nasal wash
1 second spray in each nostril, 2-3 times a day.
Interventions
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Respimer® Hygiene-Prevention -Baby, kids, adults
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
Respimer® Hygiene-Prevention Kids, adults
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
Respimer® Decongestion Baby, kids, adults
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
Phytosun arôms® Hypertonic nasal wash
1 second spray in each nostril, 2-3 times a day.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
15 Days
ALL
No
Sponsors
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EVAMED
OTHER
Laboratoire de la Mer
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-A00394-45
Identifier Type: -
Identifier Source: org_study_id
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