Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15+
SponsorLaboratoire de la Mer
About this trial
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.
Eligibility criteria
Qualifiers
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
Nasal blockage/nasal congestion/ stuffy nose;
Runny nose;
Disqualifiers
None
Trial design
Treatments tested in this trial
- Respimer® Hygiene-Prevention -Baby, kids, adults
- Respimer® Hygiene-Prevention Kids, adults
- Respimer® Decongestion Baby, kids, adults
- Phytosun arôms® Hypertonic nasal wash
Treatment groups
1,065 Participants
are divided into 4 treatment groupsSponsors and collaborators
Laboratoire de la Mer
Lead sponsor
EVAMED
Collaborator
Source ClinicalTrials.gov