RecruitingNot ApplicableNCT07262450

Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms

Real-word Study to Assess Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms


Sponsor

Laboratoire de la Mer

Enrollment

1,065 participants

Start Date

Aug 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 15 Days

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Phytosun arôms® Hypertonic nasal wash, a medical device called Respimer® Decongestion Baby, kids, adults, and others for people with allergic rhinitis, bronchiolitis, and other related conditions. The study is currently recruiting participants at 32 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERespimer® 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

DEVICERespimer® 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

DEVICERespimer® 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

DEVICEPhytosun arôms® Hypertonic nasal wash

1 second spray in each nostril, 2-3 times a day.


Locations(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

View Full Details on ClinicalTrials.gov

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NCT07262450


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