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ClinicalTrials.gov ID

NCT07262450

Lead Sponsor

Laboratoire de la MerINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

1,065Estimated

Last Update Posted

Dec 3, 2025Actual

Start Date

Aug 27, 2025Actual

Primary Completion Date

Aug 2026Estimated

Completion Date

Aug 2026Estimated

Official Title

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

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-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.

• URTI
• Bronchiolitis
• COVID - 19
• Allergic Rhinitis
• Chronic Rhinosinusitis (CRS)
• Post-surgery

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

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Laboratoire de la MerINDUSTRY

Collaborators

EVAMEDOTHER

foureclasse@hotmail.fr+33 07 62 48 03 12

florent.carsuzaa@chu-poitiers.fr+33 05 49 44 43 28