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Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms

NCT07262450 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1065

Last updated 2025-12-03

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Respimer® Hygiene-Prevention -Baby, kids, adults

1-3 seconds spray in each nostril, * 4 to 6 times a day, in treatment of nasal symptoms. * 1 to 2 times a day, in hygiene and prevention

DEVICE

Respimer® Hygiene-Prevention Kids, adults

1-2 seconds spray in each nostril, * 4 to 6 times a day, in treatment of nasal symptoms * 1 to 2 times a day, in hygiene and prevention

DEVICE

Respimer® Decongestion Baby, kids, adults

Baby (2 months+): 1-3 seconds spray in each nostril, up to 3 times a day Children (2 y+) and adults: 1-3 seconds spray in each nostril, up to 6 times a day

DEVICE

Phytosun arôms® Hypertonic nasal wash

1 second spray in each nostril, 2-3 times a day.

Sponsors & Collaborators

  • EVAMED

    collaborator OTHER

  • Laboratoire de la Mer

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-27
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07262450 on ClinicalTrials.gov