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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Respimer® Hygiene-Prevention -Baby, kids, adults
Device1-3 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
Respimer® Hygiene-Prevention Kids, adults
Device1-2 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
Respimer® Decongestion Baby, kids, adults
DeviceBaby (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
Phytosun arôms® Hypertonic nasal wash
Device1 second spray in each nostril, 2-3 times a day.
Treatment groups
1,065 Participants
are divided into 4 treatment groupsGroup A: Respimer® Hygiene-Prevention - Baby, kids, adultsOther 1 intervention
Group B: Respimer® Hygiene-Prevention - Kids, adultsOther 1 intervention
Group C: Respimer® Decongestion -Baby, kids, adultsOther 1 intervention
Group D: Phytosun arôms® Hypertonic nasal wash - Children & adultsOther 1 intervention
Trial outcomes
Primary outcomes
1
Real-life effectiveness to improve nasal symptoms in case of acute and chronic sinonasal pathologies.
Change from baseline in nasal symptom intensity following initiation of nasal wash, based on the modified SNOT-22 rhinologic score. 6-modalities intensity Likert scale: 0=No problem; 1= Very mild problem; 2=Mild or slight problem; 3= Moderate problem; 4=Severe problem; 5=Problem as bad as it can be.
Time frame
From Day 0 to Day 5 (acute indications: URTI, COVID-19, bronchiolitis) From Day 0 to Day 14 (chronic indications: allergic rhinitis, chronic rhinosinusitis, post-surgery)Secondary outcomes
1
Real-life effectiveness to reduce the intensity of individuals symptoms
Daily change from baseline in individual symptoms intensity. 6-modalities intensity Likert scale.
Time frame
From Day 0 to Day 142
Real-life effectiveness to reduce the intensity of additional extra nasal symptoms
Daily change from baseline in additional extra nasal symptoms intensity. 6-modalities intensity Likert scale.
Time frame
From Day 0 to Day 143
Real-life effectiveness to reduce the intensity of eyes symptoms
Daily change from baseline in eyes symptoms intensity. Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ): 6-modalities scale.
Time frame
From Day 0 to Day 144
Real-life effectiveness to reduce the daily intensity of symptoms
Proportion of patients presenting a daily change in symptoms intensity; Modified SNOT-22: 6-modalities intensity Likert scale. Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ): 6-modalities scale
Time frame
From Day 0 to Day 14Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Laboratoire de la Mer
Lead sponsor
EVAMED
Collaborator
Source ClinicalTrials.gov