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

Inclusion Criteria26

  • 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
  • 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.

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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

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NCT07262450


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