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Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms

RecruitingNAAges 15 Days - anyAllLaboratoire de la Mer
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion criteria: * 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 Non-inclusion criteria: * 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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What it tests

  • Respimer® Hygiene-Prevention -Baby, kids, adults
  • Respimer® Hygiene-Prevention Kids, adults
  • Respimer® Decongestion Baby, kids, adults
  • Phytosun arôms® Hypertonic nasal wash
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Where

32 sites
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

…and 24 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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