AzTrials
AzTrials

URTISeaBridgeNCT07262450

Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms

A study testing Respimer® Hygiene-Prevention -Baby, kids, adults, Respimer® Hygiene-Prevention Kids, adults and Respimer® Decongestion Baby, kids, adults in people with URTI and Bronchiolitis, run by Laboratoire de la Mer at 32 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 15 days and older
Conditions the study is for
URTI, Bronchiolitis, COVID - 19
What is being tested?
Respimer® Hygiene-Prevention -Baby, kids, adults, Respimer® Hygiene-Prevention Kids, adults and Respimer® Decongestion Baby, kids, adults
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,065 participants
Where
32 sitesFrance
Study dates
27 Aug 2025to Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 days and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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;
Show all 27Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

32 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Gaëlle NAELTEN, PharmD / PhD contact

+330633901291

gaelle.naelten@perrigo.com

32 sites in 1 country

France32 sites, 32 recruiting

  • CHU Bordeaux

    Bordeaux

    Ludovic DE GABORY, +33 05 56 79 87 88, ludovic.de-gabory@chu-bordeaux.fr

    Recruiting

  • Pharmacie de la Faïncerie

    Bourg-la-Reine

    Guillaume BICHET, +33 06 84 19 18 00, bichetguillaume@orange.fr

    Recruiting

  • Pharmacie Marine

    Cabourg

    Caroline TORCHET, +33 02 31 91 31 46, pharmaciemarine14@orange.fr

    Recruiting

  • Pharmacie Daguet

    Châteauroux

    Arnaud DAGUET, +33 06 08 52 54 69, direction.pharmacie.daguet@gmail.com

    Recruiting

  • Pharmacie des verts coteaux

    Châtenay-Malabry

    Béatrice CLAIRAZ-MAHIOU CLAIRAZ-MAHIOU, +33 01 46 32 33 77, pharmalune@orange.fr

    Recruiting

  • Pharmacie Lombard

    Châtenay-Malabry

    Sophie LOMBARD, +33 06 86 57 67 79, sguernett@yahoo.fr

    Recruiting

  • Maison Médicale Avicenne

    Chevaigné

    Pascale DELPRAT-CHATTON, +33 06 87 62 14 79, drdelpratchatton@gmail.com

    Recruiting

  • CHU de Clermont-Ferrand

    Clermont-Ferrand

    Nicolas SAROUL, +33 04 73 75 47 11, nsaroul@chu-clermontferrand.fr

    Recruiting

  • Kap Santé

    Courrières

    Amine BENALI, +33 07 62 48 03 12, foureclasse@hotmail.fr

    Recruiting

  • Pharmacie de la Liberté

    Falaise

    Jean-Marc DISSON, +33 02 31 90 10 30, phiedisson@free.fr

    Recruiting

  • Maison médicale Heyrieux

    Heyrieux

    Alexia PELI, +33 06 66 75 23 40, alexiia.p@hotmail.fr

    Recruiting

  • CHD Vendée

    La Roche-sur-Yon

    Kévin BUQUET, +33 02 51 44 65 72, kevin.buquet@ght85.fr

    Recruiting

  • CKRF Marcq en Baroeul

    Marcq-en-Barœul

    Hugues GAUCHEZ, +33 03 20 66 94 80, hgauchez@hotmail.fr

    Recruiting

  • Centre de Kinésithérapie spécialisé en rééducation respiratoire - Marseille

    Marseille

    Alain TAYABALY, +33 06 63 54 00 58, alain.kine@gmail.com

    Recruiting

  • La Maison du Souffle

    Metz

    Alexiane DAUDE, +33 06 14 25 23 26, alexiane.mazataud@yahoo.fr

    Recruiting

  • Centre médical Chamberte

    Montpellier

    Michel CHASSAGNE, +33 04 67 13 40 05, dr.chassagne@gmail.com

    Recruiting

  • CHU Poitiers

    Poitiers

    Florent CARSUZAA, +33 05 49 44 43 28, florent.carsuzaa@chu-poitiers.fr

    Recruiting

  • Pharmacie du Pot d'Etain

    Pont-Audemer

    Emilie JACQUEMIN, +33 02 32 41 04 20, pharma.pontau@gmail.com

    Recruiting

  • Pharmacie DRAPEAU

    Pont-Saint-Martin

    Mael DRAPEAU, +33 02 40 26 80 19, maelade@free.fr

    Recruiting

  • Cabinet de kinésithérapie respiratoire Sophie Jacques

    Rennes

    Sophie JACQUES, +33 06 68 66 07 20, sophieforinspire@gmail.com

    Recruiting

  • Pharmacie Deroche

    Roézé-sur-Sarthe

    Sophie DEROCHE, +33 02 43 77 39 99, pharmacie.deroche@yahoo.com

    Recruiting

  • Pharmacie Girard

    Saint-Colomban

    Pierre GIRARD, +33 02 40 05 89 26, pharmacie.girard@orange.fr

    Recruiting

  • Clinique Saint-Jean

    Saint-Jean-de-Védas

    Morgane LOPEZ, +33 06 46 87 01 33, m.lopez.kine@gmail.com

    Recruiting

  • Centre de santé respiratoire Saint Paul Lès Dax

    Saint-Paul-lès-Dax

    Paul BONNET, +33 06 83 97 19 27, paul-bonnet@hotmail.fr

    Recruiting

  • Pharmacie des Corsaires

    St-Malo

    Franck LIREUX, +33 02 99 56 01 10, pharmaciedescorsaires35@gmail.com

    Recruiting

  • Pôle Santé de Réadaptation Toulouse Ouest

    Toulouse

    Jeanne TRUCHOT, +33 06 84 72 48 18, truchot.jeanne@gmail.com

    Recruiting

  • CRKF Tourcoing

    Tourcoing

    Hugues-Amaury GAUCHEZ, +33 06 15 33 41 62, hugam@hotmail.fr

    Recruiting

  • Maison médicale Belencontre

    Tourcoing

    Maxime LAMIRAND, +33 06 07 62 67 79, dr.lamirand@maison-medicale-belencontre.fr

    Recruiting

  • Maison médicale de la Bourgogne

    Tourcoing

    Bertrand LEGRAND, +33 06 70 00 54 58, bertrandlegrand59@yahoo.fr

    Recruiting

  • Centre respiratoire de Valenciennes

    Valenciennes

    Claire BEHAGUE, +33 06 87 51 73 49, claire.behague@orange.fr

    Recruiting

  • Cabinet de Kinésithérapie HODOROABA Vincent

    Wissous

    Vincent HODOROABA, +33 06 85 42 05 23, vincent@kinesainteloi.fr

    Recruiting

  • Pharmacie St-Exupery

    Wissous

    Marie-Sophie CHAUVIN-HAMEAU, +33 01 60 49 39 73, pharmasaintex.wissous@gmail.com

    Recruiting

Other trials in France

About this study

Official title: 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.
Being tested
Respimer® Hygiene-Prevention -Baby, kids, adults, Respimer® Hygiene-Prevention Kids, adults, Respimer® Decongestion Baby, kids, adults, Phytosun arôms® Hypertonic nasal wash
Medical subject headings
Bronchiolitis, COVID-19, Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Respimer® Hygiene-Prevention -Baby, kids, adultsDevice

    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

  • Respimer® Hygiene-Prevention Kids, adultsDevice

    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

  • Respimer® Decongestion Baby, kids, adultsDevice

    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

  • Phytosun arôms® Hypertonic nasal washDevice

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

Study groups in NCT07262450
Study groupRoleWhat they receive
Respimer® Hygiene-Prevention - Baby, kids, adultsOtherRespimer® Hygiene-Prevention - Baby, kids, adults - Lavage nasal Babies from 15 days, children \& adults URTI; Bronchiolitis; Allergic rhinitis
Receives: Device: Respimer® Hygiene-Prevention -Baby, kids, adults
Respimer® Hygiene-Prevention - Kids, adultsOtherRespimer® Hygiene-Prevention Kids, Adults -Nasal wash Children from 2 years \& adults URTI; COVID-19; Allergic rhinitis; Chronic rhinosinusitis; Post-surgery
Receives: Device: Respimer® Hygiene-Prevention Kids, adults
Respimer® Decongestion -Baby, kids, adultsOtherRespimer® Decongestion Baby, kids, adults - Nasal wash Babies from 2 months, children \& adults URTI ; Allergic rhinitis; Chronic rhinosinusitis
Receives: Device: Respimer® Decongestion Baby, kids, adults
Phytosun arôms® Hypertonic nasal wash - Children & adultsOtherPhytosun arôms® Hypertonic nasal wash Children from 6 years \& adults URTI
Receives: Device: Phytosun arôms® Hypertonic nasal wash

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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 (83)

  1. Real-life effectiveness to reduce the intensity of individuals symptoms

    Daily change from baseline in individual symptoms intensity. 6-modalities intensity Likert scale.

    Measured: From Day 0 to Day 14

  2. 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.

    Measured: From Day 0 to Day 14

  3. 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.

    Measured: From Day 0 to Day 14

  4. 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

    Measured: From Day 0 to Day 14

  5. Real-life effectiveness to reduce the overall intensity of symptoms

    Daily change from baseline in the global modified SNOT-22 score and domains

    Measured: From Day 0 to Day 14

  6. Real-life effectiveness to reduce the frequency of sneezing

    Daily change from baseline in sneezing frequency. 5-modalities sneezing frequency scale

    Measured: From Day 0 to Day 14

  7. Real-life effectiveness to reduce the frequency of nose blowing

    Daily change from baseline in nose blowing frequency. 6-modalities nose blowing frequency scale

    Measured: From Day 0 to Day 14

  8. Real-life effectiveness to reduce the frequency of cough

    Daily change from baseline in cough frequency. 6-modalities Cough Symptom Score

    Measured: From Day 0 to Day 14

  9. Real-life effectiveness to relieve individual symptoms - Evolution

    Daily evolution of individual symptoms relief. Symptoms relief scale: 7-modalities scale

    Measured: From Day 0 to Day 14

  10. Real-life effectiveness to relieve individual symptoms

    Proportion of patients reporting a daily symptom relief. Symptoms relief scale: 7-modalities scale

    Measured: From Day 0 to Day 14

  11. Real-life effectiveness to relieve individual symptoms - 1st relief

    Number of days until first symptom relief. Symptoms relief scale: a 7-modalities scale

    Measured: From Day 0 to Day 14

  12. Real-life effectiveness to improve nasal breathing

    Daily change from baseline in nasal breathing difficulty. Nasal breathing difficulty scale: 6-modalities scale

    Measured: From Day 0 to Day 14

  13. Real-life effectiveness to improve nasal breathing - Onset

    Time to perceived improvement of nasal breathing. Nasal breathing scale: 7-modalities rating scale

    Measured: From Day 0 to Day 14

  14. Real-life effectiveness to improve nasal breathing - Duration

    Duration of improved nasal breathing. Improved nasal breathing scale: 7-modalities questionnaire

    Measured: From Day 0 to Day 14

  15. 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

    Measured: From Day 0 to Day 14

  16. 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

    Measured: From Day 0 to Day 14

  17. 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

    Measured: From Day 0 to Day 14

  18. 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

    Measured: From Day 0 to Day 14

  19. Real-life effectiveness to improve quality of life - Energy

    Daily change from baseline in loss of energy. 4-modalities rating energy scale

    Measured: From Day 0 to Day 14

  20. 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

    Measured: From Day 0 to Day 14

  21. 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

    Measured: From Day 0 to Day 14

  22. 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.

    Measured: From Day 0 to Day 14

  23. 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

    Measured: From Day 0 to Day 14

  24. 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

    Measured: From Day 15 to 3 months

  25. 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

    Measured: From Day 15 to 3 months

  26. 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

    Measured: From Day 15 to 3 months

  27. Real-life effectiveness to limit nasal symptoms during winter and allergy seasons - Sneezing frequency.

    Evolution of sneezing frequency. 5-modalities sneezing frequency scale

    Measured: From Day 15 to 3 months

  28. 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

    Measured: From Day 15 to 3 months

  29. 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

    Measured: From Day 15 to 3 months

  30. 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

    Measured: From Day 15 to 3 months

  31. 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

    Measured: From Day 15 to 3 months

  32. 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

    Measured: From Day 15 to 3 months

  33. 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

    Measured: From Day 15 to 3 months

  34. 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

    Measured: From Day 15 to 3 months

  35. 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

    Measured: From Day 15 to 3 months

  36. 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.

    Measured: From Day 15 to 3 months

  37. 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.

    Measured: From Day 15 to 3 months

  38. 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.

    Measured: From Day 15 to 3 months

  39. 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

    Measured: From Day 15 to 3 months

  40. 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

    Measured: From Day 15 to 3 months

  41. 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

    Measured: From Day 15 to 3 months

  42. 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

    Measured: From Day 15 to 3 months

  43. 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

    Measured: From Day 15 to 3 months

  44. 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.

    Measured: From Day 15 to 3 months

  45. 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

    Measured: From Day 15 to 3 months

  46. 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

    Measured: From Day 15 to 3 months

  47. 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

    Measured: From Day 15 to 3 months

  48. 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

    Measured: From Day 15 to 3 months

  49. 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

    Measured: From Day 15 to 3 months

  50. 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

    Measured: From Day 15 to 3 months

  51. 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

    Measured: From Day 15 to 3 months

  52. 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

    Measured: From Day 15 to 3 months

  53. 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

    Measured: From Day 15 to 3 months

  54. 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

    Measured: From Day 15 to 3 months

  55. 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.

    Measured: From Day 15 to 3 months

  56. 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

    Measured: From Day 15 to 3 months

  57. 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

    Measured: From Day 15 to 3 months

  58. 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

    Measured: From Day 15 to 3 months

  59. 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

    Measured: From Day 15 to 3 months

  60. 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.

    Measured: From Day 15 to 3 months

  61. 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

    Measured: From Day 15 to 3 months

  62. 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

    Measured: From Day 15 to 3 months

  63. 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

    Measured: From Day 15 to 3 months

  64. 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

    Measured: From Day 15 to 3 months

  65. 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

    Measured: From Day 15 to 3 months

  66. 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.

    Measured: From Day 15 to Month 3

  67. Real-life assessment of onset and duration of action and perceived effectiveness of the sprays - Duration.

    Duration of improved nasal breathing. 7-modalities questionnaire

    Measured: From Day 15 to Month 3

  68. 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

    Measured: From Day 15 to Month 3

  69. 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

    Measured: From Day 15 to Month 3

  70. 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

    Measured: From Day 0 to Month 3

  71. 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

    Measured: From Day 0 to Month 3

  72. Real-life nasal sprays usage (posology, moment of use, usage versus medication) - Co-usage with medications.

    Moments of use versus medications. Co-usage questionnaire.

    Measured: From Day 0 to Month 3

  73. 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

    Measured: From Day 15 to Month 3

  74. 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

    Measured: From Day 0 to Month 3

  75. 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

    Measured: From Day 0 to Month 3

  76. 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.

    Measured: From Day 0 to Month 3

  77. 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.

    Measured: From Day 0 to Month 3

  78. 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

    Measured: From Day 0 to Month 3

  79. 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.

    Measured: From Day 0 to Month 3

  80. 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

    Measured: From Day 0 to Month 3

  81. 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.

    Measured: From Day 0 to Month 3

  82. Assessment of the safety and tolerance of the nasal sprays - Tolerance.

    Evolution of tolerance to the nasal spray. 4-modalities scale.

    Measured: From Day 0 to Month 3

  83. 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).

    Measured: From Day 0 to Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2025
  2. Study start27 Aug 2025
  3. Primary completionAug 2026 (estimated)
  4. Study completionAug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,065 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07262450
Sponsor's protocol ID
2025-A00394-45
Acronym
SeaBridge
Status last verified
Nov 2025
First submitted
20 Nov 2025
Last updated
3 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Respimer® Hygiene-Prevention -Baby, kids, adults, Respimer® Hygiene-Prevention Kids, adults and Respimer® Decongestion Baby, kids, adults in people with URTI and Bronchiolitis, run by Laboratoire de la Mer at 32 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gaëlle NAELTEN, PharmD / PhD (+330633901291, gaelle.naelten@perrigo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Real-life effectiveness to improve nasal symptoms in case of acute and chronic sinonasal pathologies. (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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07262450.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in