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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,065
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
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
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
1 second spray in each nostril, 2-3 times a day.
CHU Bordeaux
Bordeaux, France
RECRUITINGPharmacie de la Faïncerie
Bourg-la-Reine, France
RECRUITINGPharmacie Marine
Cabourg, France
RECRUITINGPharmacie Daguet
Châteauroux, France
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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