Health Trials

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 groups

Locations

32
CHU Bordeaux Bordeaux France
Pharmacie de la Faïncerie Bourg-la-Reine France
Pharmacie Marine Cabourg France
Pharmacie Daguet Châteauroux France

Sponsors and collaborators

Laboratoire de la Mer

Lead sponsor

EVAMED

Collaborator

Source ClinicalTrials.gov