Overview

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

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.