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Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms (SeaBridge)

L

Laboratoire de la Mer

Status

Enrolling

Conditions

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

Treatments

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

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT07262450
2025-A00394-45

Details and patient eligibility

About

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.

Enrollment

1,065 estimated patients

Sex

All

Ages

15+ days old

Volunteers

No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,065 participants in 4 patient groups

Respimer® Hygiene-Prevention - Baby, kids, adults
Other group
Description:
Respimer® Hygiene-Prevention - Baby, kids, adults - Lavage nasal Babies from 15 days, children \& adults URTI; Bronchiolitis; Allergic rhinitis
Treatment:
Device: Respimer® Hygiene-Prevention -Baby, kids, adults
Respimer® Hygiene-Prevention - Kids, adults
Other group
Description:
Respimer® Hygiene-Prevention Kids, Adults -Nasal wash Children from 2 years \& adults URTI; COVID-19; Allergic rhinitis; Chronic rhinosinusitis; Post-surgery
Treatment:
Device: Respimer® Hygiene-Prevention Kids, adults
Respimer® Decongestion -Baby, kids, adults
Other group
Description:
Respimer® Decongestion Baby, kids, adults - Nasal wash Babies from 2 months, children \& adults URTI ; Allergic rhinitis; Chronic rhinosinusitis
Treatment:
Device: Respimer® Decongestion Baby, kids, adults
Phytosun arôms® Hypertonic nasal wash - Children & adults
Other group
Description:
Phytosun arôms® Hypertonic nasal wash Children from 6 years \& adults URTI
Treatment:
Device: Phytosun arôms® Hypertonic nasal wash

Trial contacts and locations

32

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Central trial contact

Gaëlle NAELTEN, PharmD / PhD

Data sourced from clinicaltrials.gov

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