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

Real-word Study to Assess Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms

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.

Study Overview

• Status: Recruiting
• Conditions: Allergic Rhinitis; Bronchiolitis; URTI; COVID - 19; Chronic Rhinosinusitis (CRS); Post-surgery
• Intervention / Treatment: Device: Respimer® Hygiene-Prevention -Baby, kids, adults; Device: Respimer® Hygiene-Prevention Kids, adults; Device: Respimer® Decongestion Baby, kids, adults; Device: Phytosun arôms® Hypertonic nasal wash

• Study Type: Interventional
• Enrollment (Estimated): 1065
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gaëlle NAELTEN, PharmD / PhD; Phone Number: +330633901291; Email: gaelle.naelten@perrigo.com

Study Locations

• France
  • Bordeaux, France
    • Recruiting
    • CHU Bordeaux
    • Contact: Ludovic DE GABORY; Phone Number: +33 05 56 79 87 88; Email: ludovic.de-gabory@chu-bordeaux.fr
  • Bourg-la-Reine, France
    • Recruiting
    • Pharmacie de la Faïncerie
    • Contact: Guillaume BICHET; Phone Number: +33 06 84 19 18 00; Email: bichetguillaume@orange.fr
  • Cabourg, France
    • Recruiting
    • Pharmacie Marine
    • Contact: Caroline TORCHET; Phone Number: +33 02 31 91 31 46; Email: pharmaciemarine14@orange.fr
  • Chevaigné, France
    • Recruiting
    • Maison Médicale Avicenne
    • Contact: Pascale DELPRAT-CHATTON; Phone Number: +33 06 87 62 14 79; Email: drdelpratchatton@gmail.com
  • Châteauroux, France
    • Recruiting
    • Pharmacie Daguet
    • Contact: Arnaud DAGUET; Phone Number: +33 06 08 52 54 69; Email: direction.pharmacie.daguet@gmail.com
  • Châtenay-Malabry, France
    • Recruiting
    • Pharmacie des verts coteaux
    • Contact: Béatrice CLAIRAZ-MAHIOU CLAIRAZ-MAHIOU; Phone Number: +33 01 46 32 33 77; Email: pharmalune@orange.fr
  • Châtenay-Malabry, France
    • Recruiting
    • Pharmacie Lombard
    • Contact: Sophie LOMBARD; Phone Number: +33 06 86 57 67 79; Email: sguernett@yahoo.fr
  • Clermont-Ferrand, France
    • Recruiting
    • CHU de Clermont-Ferrand
    • Contact: Nicolas SAROUL; Phone Number: +33 04 73 75 47 11; Email: nsaroul@chu-clermontferrand.fr
  • Courrières, France
    • Recruiting
    • Kap Santé
    • Contact: Amine BENALI; Phone Number: +33 07 62 48 03 12; Email: foureclasse@hotmail.fr
  • Falaise, France
    • Recruiting
    • Pharmacie de la Liberté
    • Contact: Jean-Marc DISSON; Phone Number: +33 02 31 90 10 30; Email: phiedisson@free.fr
  • Heyrieux, France
    • Recruiting
    • Maison médicale Heyrieux
    • Contact: Alexia PELI; Phone Number: +33 06 66 75 23 40; Email: alexiia.p@hotmail.fr
  • La Roche-sur-Yon, France
    • Recruiting
    • CHD Vendee
    • Contact: Kévin BUQUET; Phone Number: +33 02 51 44 65 72; Email: kevin.buquet@ght85.fr
  • Marcq-en-Barœul, France
    • Recruiting
    • CKRF Marcq en Baroeul
    • Contact: Hugues GAUCHEZ; Phone Number: +33 03 20 66 94 80; Email: hgauchez@hotmail.fr
  • Marseille, France
    • Recruiting
    • Centre de Kinésithérapie spécialisé en rééducation respiratoire - Marseille
    • Contact: Alain TAYABALY; Phone Number: +33 06 63 54 00 58; Email: alain.kine@gmail.com
  • Metz, France
    • Recruiting
    • La Maison du Souffle
    • Contact: Alexiane DAUDE; Phone Number: +33 06 14 25 23 26; Email: alexiane.mazataud@yahoo.fr
  • Montpellier, France
    • Recruiting
    • Centre médical Chamberte
    • Contact: Michel CHASSAGNE; Phone Number: +33 04 67 13 40 05; Email: dr.chassagne@gmail.com
  • Poitiers, France
    • Recruiting
    • CHU Poitiers
    • Contact: Florent CARSUZAA; Phone Number: +33 05 49 44 43 28; Email: florent.carsuzaa@chu-poitiers.fr
  • Pont-Audemer, France
    • Recruiting
    • Pharmacie du Pot d'Etain
    • Contact: Emilie JACQUEMIN; Phone Number: +33 02 32 41 04 20; Email: pharma.pontau@gmail.com
  • Pont-Saint-Martin, France
    • Recruiting
    • Pharmacie DRAPEAU
    • Contact: Mael DRAPEAU; Phone Number: +33 02 40 26 80 19; Email: maelade@free.fr
  • Rennes, France
    • Recruiting
    • Cabinet de kinésithérapie respiratoire Sophie Jacques
    • Contact: Sophie JACQUES; Phone Number: +33 06 68 66 07 20; Email: sophieforinspire@gmail.com
  • Roézé-sur-Sarthe, France
    • Recruiting
    • Pharmacie Deroche
    • Contact: Sophie DEROCHE; Phone Number: +33 02 43 77 39 99; Email: pharmacie.deroche@yahoo.com
  • Saint-Colomban, France
    • Recruiting
    • Pharmacie Girard
    • Contact: Pierre GIRARD; Phone Number: +33 02 40 05 89 26; Email: pharmacie.girard@orange.fr
  • Saint-Jean-de-Védas, France
    • Recruiting
    • Clinique Saint-Jean
    • Contact: Morgane LOPEZ; Phone Number: +33 06 46 87 01 33; Email: m.lopez.kine@gmail.com
  • Saint-Paul-lès-Dax, France
    • Recruiting
    • Centre de santé respiratoire Saint Paul Lès Dax
    • Contact: Paul BONNET; Phone Number: +33 06 83 97 19 27; Email: paul-bonnet@hotmail.fr
  • St-Malo, France
    • Recruiting
    • Pharmacie des Corsaires
    • Contact: Franck LIREUX; Phone Number: +33 02 99 56 01 10; Email: pharmaciedescorsaires35@gmail.com
  • Toulouse, France
    • Recruiting
    • Pôle Santé de Réadaptation Toulouse Ouest
    • Contact: Jeanne TRUCHOT; Phone Number: +33 06 84 72 48 18; Email: truchot.jeanne@gmail.com
  • Tourcoing, France
    • Recruiting
    • CRKF Tourcoing
    • Contact: Hugues-Amaury GAUCHEZ; Phone Number: +33 06 15 33 41 62; Email: hugam@hotmail.fr
  • Tourcoing, France
    • Recruiting
    • Maison médicale Belencontre
    • Contact: Maxime LAMIRAND; Phone Number: +33 06 07 62 67 79; Email: dr.lamirand@maison-medicale-belencontre.fr
  • Tourcoing, France
    • Recruiting
    • Maison médicale de la Bourgogne
    • Contact: Bertrand LEGRAND; Phone Number: +33 06 70 00 54 58; Email: bertrandlegrand59@yahoo.fr
  • Valenciennes, France
    • Recruiting
    • Centre respiratoire de Valenciennes
    • Contact: Claire BEHAGUE; Phone Number: +33 06 87 51 73 49; Email: claire.behague@orange.fr
  • Wissous, France
    • Recruiting
    • Cabinet de Kinésithérapie HODOROABA Vincent
    • Contact: Vincent HODOROABA; Phone Number: +33 06 85 42 05 23; Email: vincent@kinesainteloi.fr
  • Wissous, France
    • Recruiting
    • Pharmacie St-Exupery
    • Contact: Marie-Sophie CHAUVIN-HAMEAU; Phone Number: +33 01 60 49 39 73; Email: pharmasaintex.wissous@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Respimer® Hygiene-Prevention - Baby, kids, adults; Respimer® Hygiene-Prevention - Baby, kids, adults - Lavage nasal Babies from 15 days, children & adults URTI; Bronchiolitis; Allergic rhinitis	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
Other: Respimer® Hygiene-Prevention - Kids, adults; Respimer® Hygiene-Prevention Kids, Adults -Nasal wash Children from 2 years & adults URTI; COVID-19; Allergic rhinitis; Chronic rhinosinusitis; Post-surgery	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
Other: Respimer® Decongestion -Baby, kids, adults; Respimer® Decongestion Baby, kids, adults - Nasal wash Babies from 2 months, children & adults URTI ; Allergic rhinitis; Chronic rhinosinusitis	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
Other: Phytosun arôms® Hypertonic nasal wash - Children & adults; Phytosun arôms® Hypertonic nasal wash Children from 6 years & adults URTI	Device: Phytosun arôms® Hypertonic nasal wash; 1 second spray in each nostril, 2-3 times a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Real-life effectiveness to reduce the intensity of individuals symptoms	Daily change from baseline in individual symptoms intensity. 6-modalities intensity Likert scale.	From Day 0 to Day 14
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.	From Day 0 to Day 14
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.	From Day 0 to Day 14
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	From Day 0 to Day 14
Real-life effectiveness to reduce the overall intensity of symptoms	Daily change from baseline in the global modified SNOT-22 score and domains	From Day 0 to Day 14
Real-life effectiveness to reduce the frequency of sneezing	Daily change from baseline in sneezing frequency. 5-modalities sneezing frequency scale	From Day 0 to Day 14
Real-life effectiveness to reduce the frequency of nose blowing	Daily change from baseline in nose blowing frequency. 6-modalities nose blowing frequency scale	From Day 0 to Day 14
Real-life effectiveness to reduce the frequency of cough	Daily change from baseline in cough frequency. 6-modalities Cough Symptom Score	From Day 0 to Day 14
Real-life effectiveness to relieve individual symptoms - Evolution	Daily evolution of individual symptoms relief. Symptoms relief scale: 7-modalities scale	From Day 0 to Day 14
Real-life effectiveness to relieve individual symptoms	Proportion of patients reporting a daily symptom relief. Symptoms relief scale: 7-modalities scale	From Day 0 to Day 14
Real-life effectiveness to relieve individual symptoms - 1st relief	Number of days until first symptom relief. Symptoms relief scale: a 7-modalities scale	From Day 0 to Day 14
Real-life effectiveness to improve nasal breathing	Daily change from baseline in nasal breathing difficulty. Nasal breathing difficulty scale: 6-modalities scale	From Day 0 to Day 14
Real-life effectiveness to improve nasal breathing - Onset	Time to perceived improvement of nasal breathing. Nasal breathing scale: 7-modalities rating scale	From Day 0 to Day 14
Real-life effectiveness to improve nasal breathing - Duration	Duration of improved nasal breathing. Improved nasal breathing scale: 7-modalities questionnaire	From Day 0 to Day 14
Real-life effectiveness to improve nasal breathing - Time interval	Daily average time between two consecutive nasal washes. Open question whose unit of measurement is in hours	From Day 0 to Day 14
Real-life effectiveness to improve nasal blowing/removal of secretions	Daily change from baseline in nose blowing/removal of secretions Easiness to blow the nose/remove secretions scale: 5-modalities rating scale	From Day 0 to Day 14
Real-life effectiveness to improve quality of secretions	Daily change from baseline in quality of nasal secretions. Quality of nasal secretions scale: 4-modalities rating scale	From Day 0 to Day 14
Real-life effectiveness to improve quality of life	Daily change from baseline in subjects' quality of life. QOL items of the modified SNOT-22 questionnaire: 6-modalities intensity Likert scale	From Day 0 to Day 14
Real-life effectiveness to improve quality of life - Energy	Daily change from baseline in loss of energy. 4-modalities rating energy scale	From Day 0 to Day 14
Real-life effectiveness to improve quality of life - Daily activities	Daily change from baseline in symptoms interference with daily activities. Symptom interference scale: 5-modalities rating scale	From Day 0 to Day 14
Real-life effectiveness to improve quality of life - Feeding difficulties	Daily change from baseline in feeding difficulties. Babies's feeding difficulty scale: 0-10 VAS scale	From Day 0 to Day 14
Real-life effectiveness to improve quality of life - Baby and young child	Daily change from baseline in cries frequency, irritability, comfort and wellbeing, overall behaviour. Baby and young child quality of life scale: 6-modalities rating scale.	From Day 0 to Day 14
Real-life effectiveness to improve quality of life of the family	Daily change from baseline in family/parental quality of life. Family/parental quality of life scale: 6-modalities rating scale	From Day 0 to Day 14
Real-life effectiveness to limit nasal symptoms during winter and allergy seasons	Number and proportion of subjects with nasal symptoms. Modified SNOT-22 self-questionnaire: 6-modalities intensity Likert scale	From Day 15 to 3 months
Real-life effectiveness to limit nasal symptoms during winter and allergy seasons.	Number of nasal symptoms per subject. Modified SNOT-22 self-questionnaire: 6-modalities intensity Likert scale	From Day 15 to 3 months
Real-life effectiveness to limit nasal symptoms during winter and allergy seasons.	Evolution of nasal symptoms intensity. SNOT-22 self-questionnaire: 6-modalities intensity Likert scale	From Day 15 to 3 months
Real-life effectiveness to limit nasal symptoms during winter and allergy seasons - Sneezing frequency.	Evolution of sneezing frequency. 5-modalities sneezing frequency scale	From Day 15 to 3 months
Real-life effectiveness to limit nasal symptoms during winter and allergy seasons - Nose blowing.	Evolution of nose blowing/Need to rub the nose frequency. 6-modalities nose blowing frequency scale	From Day 15 to 3 months
Real-life effectiveness to limit extra-nasal symptoms during winter and allergy seasons.	Number and proportion of subjects with extra-nasal symptoms. Modified SNOT-22 self questionnaire: 6-modalities scale	From Day 15 to 3 months
Real-life effectiveness to limit extra-nasal symptoms during winter and allergy seasons.	Number of extra-nasal symptoms per subject. Modified SNOT-22 self questionnaire: 6-modalities scale	From Day 15 to 3 months
Real-life effectiveness to limit extra-nasal symptoms during winter and allergy seasons.	Evolution of extra-nasal symptoms intensity. Modified SNOT-22 self questionnaire: 6-modalities scale	From Day 15 to 3 months
Real-life effectiveness to limit extra-nasal symptoms during winter and allergy seasons - Eyes symptoms.	Evolution of eyes symptoms intensity for allergic rhinitis sufferers. Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ):7-point Likert scale	From Day 15 to 3 months
Real-life effectiveness to limit extra-nasal symptoms during winter and allergy seasons.	Evolution of modified SNOT-22 domains. Modified SNOT-22 self-questionnaire: 6-modalities scale	From Day 15 to 3 months
Real-life effectiveness to limit extra-nasal symptoms during winter and allergy seasons .	Evolution of modified SNOT-22 global score. Modified SNOT-22 self-questionnaire: 6-modalities scale	From Day 15 to 3 months
Real-life effectiveness to limit extra-nasal symptoms during winter and allergy seasons - Cough, snoring, wake-up at night.	Evolution of cough, snoring, wake up at night. Snoring, wake up at night (due to symptoms), cough frequency scale: 7-modalities rating scale	From Day 15 to 3 months
Real-life effectiveness to limit extra-nasal symptoms during winter and allergy seasons - Acute respiratory infections.	Number and proportion of subjects with acute respiratory infection. Multiple-choice question regarding acute respiratory infection including the start date of the symptoms.	From Day 15 to 3 months
Real-life effectiveness to limit extra-nasal symptoms during winter and allergy seasons - Allergic rhinitis episodes.	Number and proportion of subjects with acute allergic rhinitis episodes (for allergic rhinitis sufferers). Open question whose unit of measurement is in number of episodes.	From Day 15 to 3 months
Real-life effectiveness to limit extra-nasal symptoms during winter and allergy seasons - Asthma episodes.	Number and proportion of subjects with asthma episodes/exacerbations (for allergic rhinitis sufferers). Open question whose unit measurement is in number of episodes.	From Day 15 to 3 months
Real-life effectiveness to improve nasal breathing quality during winter and allergy seasons.	Evolution of nasal breathing score. Nasal breathing difficulty scale: 6-modalities scale	From Day 15 to 3 months
Real-life effectiveness to improve quality of life (QOL) during winter and allergy seasons.	Evolution in modified SNOT-22 quality of life items. Modified SNOT-22 self-questionnaire: 6-modalities intensity Likert scale	From Day 15 to 3 months
Real-life effectiveness to improve quality of life (QOL) during winter and allergy seasons - Energy.	Evolution in loss of energy. 4-modalities rating energy scale	From Day 15 to 3 months
Real-life effectiveness to improve quality of life (QOL) during winter and allergy seasons - Well-being & global health status	Evolution of well-being and global health status. 0-10 VAS scale	From Day 15 to 3 months
Real-life effectiveness to improve quality of life (QOL) during winter and allergy seasons - Daily activities.	Evolution of symptom interference with daily activities. 5-modalities rating scale	From Day 15 to 3 months
Real-life effectiveness to improve quality of life (QOL) during winter and allergy seasons - Practical problems.	Evolution in practical problems (inconvenience of having to carry tissues/hankerchiefs, need to rub nose/eye, need to blow your nose repeatedly), for allergic rhinitis sufferers. 6 modalities Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scale.	From Day 15 to 3 months
Real-life effectiveness to limit the number of illness and missed days.	Number of days with sickness / nasal symptoms. Open question whose unit of measurement is in number of days	From Day 15 to 3 months
Real-life effectiveness to limit the number of illness and missed days.	Number and percentage of subjects with sickness days . Open question whose unit of measurement is in number of days	From Day 15 to 3 months
Real-life effectiveness to limit the number of illness and missed days.	Number of missed days (work, school, daycare). Open question whose unit of measurement is in number of days	From Day 15 to 3 months
Real-life effectiveness to limit the number of illness and missed days.	Number and percentage of subjects with missed days (work, school, daycare). Open question whose unit of measurement is in number of days	From Day 15 to 3 months
Real-life effectiveness to limit the impact on daily life for the family.	Number of days of parental absence (work activities) due to baby/child's disease. Open question whose unit of measurement is in number of days	From Day 15 to 3 months
Real-life effectiveness to limit the impact on daily life for the family .	Number and percentage of parents with missed days (work, activities). Open question whose unit of measurement is in number of days	From Day 15 to 3 months
Real-life effectiveness to limit the impact on daily life for the family.	Number of days with impaired family/parental quality of life. Family/parental quality of life scale : 6-modalities rating scale	From Day 15 to 3 months
Real-life effectiveness to limit the impact on daily life for the family .	Number and percentage of parents/family with impaired quality of life. Family/parental quality of life scale: 6 modalities rating scale	From Day 15 to 3 months
Real-life effectiveness to reduce the intake of concomitant medications during winter and allergy seasons.	Number and percentage of subjects with intake of medications. Questions about name of the treatment, route of administration and number of days of use for each treatement	From Day 15 to 3 months
Real-life effectiveness to reduce the intake of concomitant medications during winter and allergy seasons.	Number of days with intake of medications. Question about name of the treatment, route of administration and number of days of use for each treatement	From Day 15 to 3 months
Real-life effectiveness to reduce the intake of concomitant medications during winter and allergy seasons.	Number and percentage of subjects in control group with re-introduction of nasal wash. Question about the name and format of the nasal wash product and number of days of use.	From Day 15 to 3 months
Real-life effectiveness to reduce the intake of concomitant medications during winter and allergy seasons.	Evolution of allergic rhinitis treatment for allergic rhinitis sufferers. 3-modalities scale	From Day 15 to 3 months
Real-life effectiveness to reduce the evolution towards more severe form or complications.	Number and percentage of subjects with severe symptoms intensity. Modified SNOT-22 self-questionnaire: 6-modalities intensity Likert scale	From Day 15 to 3 months
Real-life effectiveness to reduce the evolution towards more severe form or complications - Extra-nasal symptoms.	Number and percentage of subjects with severe extra-nasal symptoms intensity. Modified SNOT-22 self-questionnaire: 6-modalities intensity Likert scale	From Day 15 to 3 months
Real-life effectiveness to reduce the evolution towards more severe form or complications - Eyes symptoms.	Number and percentage of subjects with severe eyes symptom intensity. Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scale: 7-point Likert scale	From Day 15 to 3 months
Real-life effectiveness to reduce the evolution towards more severe form or complications - Complications.	Number and percentage of subjects with occurence of complications. Multiple-choice question.	From Day 15 to 3 months
Real-life effectiveness to reduce the evolution towards more severe form or complications - Asthma.	Evolution of asthma symptoms frequency for asthma sufferers. 7-modalities frequency scale	From Day 15 to 3 months
Real-life effectiveness to reduce the evolution towards more severe form or complications - Asthma episodes.	Number and percentage of subjects with asthma episodes/exacerbation for asthma sufferers. Open question	From Day 15 to 3 months
Real-life effectiveness to reduce the evolution towards more severe form or complications - Asthma intensity.	Evolution of asthma symptoms intensity for asthma sufferers. 7-modalities scale	From Day 15 to 3 months
Real-life effectiveness to reduce the need for unplanned HCP care during winter and allergy seasons.	Number and percentage of subjects consulting a HCP. Collection of unplanned HCP consultations because of nasal/respiratory symptoms	From Day 15 to 3 months
Real-life effectiveness to reduce the need for unplanned HCP care during winter and allergy seasons - Hospitalizations.	Number and percentage of hospitalized subjects. Collection of hospitalizations due to nasal/respiratory symptoms	From Day 15 to 3 months
Real-life assessment of onset and duration of action and perceived effectiveness of the sprays - Onset.	Time to perceived improvement of nasal breathing. 7 modalities rating scale.	From Day 15 to Month 3
Real-life assessment of onset and duration of action and perceived effectiveness of the sprays - Duration.	Duration of improved nasal breathing. 7-modalities questionnaire	From Day 15 to Month 3
Real-life assessment of onset and duration of action and perceived effectiveness of the sprays.	Daily average time between two consecutive nasal washes. Open question whose unit of measurement is in hours	From Day 15 to Month 3
Real-life assessment of onset and duration of action and perceived effectiveness of the sprays - Allergic rhinitis.	Number and percentage of subjects with improved effectiveness of their usual allergic rhinitis treatment. 7-modalities questionnaire	From Day 15 to Month 3
Real-life nasal sprays usage (posology, moment of use, usage versus medication) - Posology.	Number of nasal wash per day and Number of days of use per week . 8-modalities posology questionnaire	From Day 0 to Month 3
Real-life nasal sprays usage (posology, moment of use, usage versus medication) - Moment of use.	Moments of use of the nasal spray during the day. 7-modalities multiple choice question	From Day 0 to Month 3
Real-life nasal sprays usage (posology, moment of use, usage versus medication) - Co-usage with medications.	Moments of use versus medications. Co-usage questionnaire.	From Day 0 to Month 3
Real-life nasal sprays usage (posology, moment of use, usage versus medication) - Occasion of use.	Occasion of use during the prevention phase. Multiple-choice question	From Day 15 to Month 3
Real-life nasal sprays usage (posology, moment of use, usage versus medication) - Baby nasal aspirator.	Complementary usage of a baby nasal aspirator. 7-modalities frequency scale	From Day 0 to Month 3
Real-life nasal sprays usage (posology, moment of use, usage versus medication) - Child autonomy.	Child's autonomy in using the nasal spray. Multiple-choice question	From Day 0 to Month 3
Real-life assessment of satisfaction and willingness to reuse and recommandation of the nasal sprays - Satisfaction.	Number and percentage of subjects satisfied with the use of the nasal spray. 5-modalities satisfaction scale.	From Day 0 to Month 3
Real-life assessment of satisfaction and willingness to reuse and recommandation of the nasal sprays - Perceived sensation.	Perceived sensation after application. 5-modalities sensory scale.	From Day 0 to Month 3
Real-life assessment of satisfaction and willingness to reuse and recommandation of the nasal sprays - Perceived effectiveness.	Global perceived effectiveness of the nasal spray. 6-modalities rating scale	From Day 0 to Month 3
Real-life assessment of satisfaction and willingness to reuse and recommandation of the nasal sprays - Practicality.	Practicality of the product, easiness to use. 6-modalities technical performance agreement scale.	From Day 0 to Month 3
Real-life assessment of satisfaction and willingness to reuse and recommendation of the nasal sprays - Reuse and recommend.	Number and percentage of subjects with willingness to reuse, willingness to recommend the nasal spray. 4-modalities scale	From Day 0 to Month 3
Real-life assessment of satisfaction and willingness to reuse and recommandation of the nasal sprays - Educational content.	Usefulness of the educational content (tutorial and tips). Multiple choice satisfaction questionnaire.	From Day 0 to Month 3
Assessment of the safety and tolerance of the nasal sprays - Tolerance.	Evolution of tolerance to the nasal spray. 4-modalities scale.	From Day 0 to Month 3
Assessment of the safety and tolerance of the nasal sprays - Safety.	Number and percentage of incidents reported during the clinical investigation. Number and percentage of subjects reporting incidents during the clinical investigation. Collection of incidents and adverse events (nature, dates of occurrence and evolution).	From Day 0 to Month 3

Collaborators and Investigators

• Sponsor: Laboratoire de la Mer
• Collaborators: EVAMED

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Nose Diseases; Otorhinolaryngologic Diseases; Bronchitis; Rhinitis; COVID-19; Bronchiolitis; Rhinitis, Allergic
• Other Study ID Numbers: 2025-A00394-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No