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RecruitingNCT07262450SeaBridgeUpdated Dec 3, 2025

Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms

An interventional study of Respimer® Hygiene-Prevention -Baby, kids, adults and Respimer® Hygiene-Prevention Kids, adults in URTI, Bronchiolitis and COVID - 19, sponsored by Laboratoire de la Mer. Recruiting at 32 sites in France. Open to participants aged 15 Days and older. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by Laboratoire de la Mer · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Aug 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
1,065
Allocation
Randomized
Ages
15 Days and older
Sex
All
01

Study 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.

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.
02

Conditions studied

  • URTI
  • Bronchiolitis
  • COVID - 19
  • Allergic Rhinitis
  • Chronic Rhinosinusitis (CRS)
  • Post-surgery
03

In context

Bronchiolitis

289 studies on the registry are indexed under Bronchiolitis; 51 are open to participants now.

This study's planned enrollment of 1,065 is above the median of 100 across 195 interventional studies indexed under Bronchiolitis.

Browse Bronchiolitis studies →

Lead sponsor

Laboratoire de la Mer is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Days and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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 .
  • Subject affiliated to the health social security system or beneficiary of an equivalent system

Non-inclusion criteria:

  • Subject with according to each IFU.
  • or known allergy to any component of the 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,065 participants (estimated)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • DeviceRespimer® 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

  • DeviceRespimer® 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

  • DeviceRespimer® 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

  • DevicePhytosun arôms® Hypertonic nasal wash

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

06

What researchers measure

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 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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.

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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).

    Time frame: From Day 0 to Month 3

07

Study locations

32 of 32 sites recruiting
  • CHU Bordeaux
    Bordeaux, France
    Recruiting
  • Pharmacie de la Faïncerie
    Bourg-la-Reine, France
    Recruiting
  • Pharmacie Marine
    Cabourg, France
    Recruiting
  • Pharmacie Daguet
    Châteauroux, France
    Recruiting
  • Pharmacie des verts coteaux
    Châtenay-Malabry, France
    Recruiting
  • Pharmacie Lombard
    Châtenay-Malabry, France
    Recruiting
  • Maison Médicale Avicenne
    Chevaigné, France
    Recruiting
  • CHU de Clermont-Ferrand
    Clermont-Ferrand, France
    Recruiting
  • Kap Santé
    Courrières, France
    Recruiting
  • Pharmacie de la Liberté
    Falaise, France
    Recruiting
  • Maison médicale Heyrieux
    Heyrieux, France
    Recruiting
  • CHD Vendée
    La Roche-sur-Yon, France
    Recruiting
  • CKRF Marcq en Baroeul
    Marcq-en-Barœul, France
    Recruiting
  • Centre de Kinésithérapie spécialisé en rééducation respiratoire - Marseille
    Marseille, France
    Recruiting
  • La Maison du Souffle
    Metz, France
    Recruiting
  • Centre médical Chamberte
    Montpellier, France
    Recruiting
  • CHU Poitiers
    Poitiers, France
    Recruiting
  • Pharmacie du Pot d'Etain
    Pont-Audemer, France
    Recruiting
  • Pharmacie DRAPEAU
    Pont-Saint-Martin, France
    Recruiting
  • Cabinet de kinésithérapie respiratoire Sophie Jacques
    Rennes, France
    Recruiting
  • Pharmacie Deroche
    Roézé-sur-Sarthe, France
    Recruiting
  • Pharmacie Girard
    Saint-Colomban, France
    Recruiting
  • Clinique Saint-Jean
    Saint-Jean-de-Védas, France
    Recruiting
  • Centre de santé respiratoire Saint Paul Lès Dax
    Saint-Paul-lès-Dax, France
    Recruiting
  • Pharmacie des Corsaires
    St-Malo, France
    Recruiting
  • Pôle Santé de Réadaptation Toulouse Ouest
    Toulouse, France
    Recruiting
  • CRKF Tourcoing
    Tourcoing, France
    Recruiting
  • Maison médicale Belencontre
    Tourcoing, France
    Recruiting
  • Maison médicale de la Bourgogne
    Tourcoing, France
    Recruiting
  • Centre respiratoire de Valenciennes
    Valenciennes, France
    Recruiting
  • Cabinet de Kinésithérapie HODOROABA Vincent
    Wissous, France
    Recruiting
  • Pharmacie St-Exupery
    Wissous, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Aug 2026, 12 months after the start.

Of 57 interventional studies with no phase under Bronchiolitis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 20, 2025
First posted
Dec 3, 2025
StartActual
Aug 27, 2025
Primary completionEst.
Aug 2026
CompletionEst.
Aug 2026
Last update
Dec 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07262450
Lead sponsor
Laboratoire de la Mer
Collaborators
EVAMED
Responsible party
Sponsor
First posted
Dec 3, 2025
Start date
Aug 27, 2025
Primary completion
Aug 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Dec 3, 2025

Study contacts

Gaëlle NAELTEN, PharmD / PhD
Contact
gaelle.naelten@perrigo.com
+330633901291

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Laboratoire de la Mer

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