Status:
RECRUITING
Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms
Lead Sponsor:
Laboratoire de la Mer
Collaborating Sponsors:
EVAMED
Conditions:
URTI
Bronchiolitis
Eligibility:
All Genders
15+ years
Phase:
NA
Brief 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-...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
August 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
1065 Patients enrolled
Trial Details
Trial ID
NCT07262450
Start Date
August 27 2025
End Date
August 1 2026
Last Update
December 3 2025
Active Locations (32)
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1
CHU Bordeaux
Bordeaux, France
2
Pharmacie de la Faïncerie
Bourg-la-Reine, France
3
Pharmacie Marine
Cabourg, France
4
Pharmacie Daguet
Châteauroux, France