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Seawater nasal sprays for relief of nasal and sinus symptoms

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

Not applicable Interventional Laboratoire de la Mer · NCT07262450

This project will test four seawater nasal sprays to see if they help infants, children, adults, and pregnant or breastfeeding people with acute or chronic nasal and sinus symptoms.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1065 (estimated)
Ages15 Days and up
SexAll
SponsorLaboratoire de la Mer Industry-sponsored
Locations32 sites (Bordeaux and 31 other locations)
Trial IDNCT07262450 on ClinicalTrials.gov

What this trial studies

In a post-market, real-life setting, this investigation will follow people using four CE-marked isotonic and hypertonic seawater nasal sprays used according to each device's intended instructions. The study will collect data on symptom change, device usage patterns, tolerance, safety events, and user satisfaction across age groups including infants and pregnant or breastfeeding women with conditions such as URTI, bronchiolitis, COVID-19, allergic rhinitis, and chronic rhinosinusitis. Eligible participants must report at least two moderate nasal symptoms and, for acute presentations, symptom onset within 72 hours; treatments will be applied as in routine practice. Outcomes will rely mainly on patient-reported symptom scores, safety/tolerance reporting, and device usage information.

Who should consider this trial

Good fit: Ideal candidates are infants, children, adults, or pregnant/breastfeeding people with acute or chronic sinonasal conditions (URTI, bronchiolitis, COVID-19, allergic rhinitis, or chronic rhinosinusitis) who have at least two moderate nasal symptoms and, for acute cases, symptom onset within 72 hours.

Not a fit: People without significant nasal symptoms, those whose breathing problems are primarily due to non-nasal causes, or those requiring urgent medical or surgical treatment are unlikely to benefit from these nasal washes.

Why it matters

Potential benefit: If successful, these nasal sprays could reduce nasal congestion and other sinonasal symptoms and improve comfort with a low-risk, nonpharmacologic option.

How similar studies have performed: Previous clinical and post-market studies of saline and seawater nasal irrigation have generally shown symptomatic benefit for common colds and chronic rhinosinusitis, although results vary by formulation, tonicity, and patient population.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Bordeaux and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions URTIBronchiolitisCOVID - 19Allergic RhinitisChronic RhinosinusitisPost-surgery
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.