Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms

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.

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

Daily change from baseline in additional extra nasal symptoms intensity. 6-modalities intensity Likert scale.

Daily change from baseline in eyes symptoms intensity. Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ): 6-modalities scale.

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

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

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

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

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

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

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

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

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

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

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

Daily average time between two consecutive nasal washes. Open question whose unit of measurement is in hours

Daily change from baseline in nose blowing/removal of secretions Easiness to blow the nose/remove secretions scale: 5-modalities rating scale

Daily change from baseline in quality of nasal secretions. Quality of nasal secretions scale: 4-modalities rating scale

Daily change from baseline in subjects' quality of life. QOL items of the modified SNOT-22 questionnaire: 6-modalities intensity Likert scale

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

Daily change from baseline in symptoms interference with daily activities. Symptom interference scale: 5-modalities rating scale

Daily change from baseline in feeding difficulties. Babies's feeding difficulty scale: 0-10 VAS scale

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.

Daily change from baseline in family/parental quality of life. Family/parental quality of life scale: 6-modalities rating scale

Number and proportion of subjects with nasal symptoms. Modified SNOT-22 self-questionnaire: 6-modalities intensity Likert scale

Number of nasal symptoms per subject. Modified SNOT-22 self-questionnaire: 6-modalities intensity Likert scale

Evolution of nasal symptoms intensity. SNOT-22 self-questionnaire: 6-modalities intensity Likert scale

Evolution of sneezing frequency. 5-modalities sneezing frequency scale

Evolution of nose blowing/Need to rub the nose frequency. 6-modalities nose blowing frequency scale

Number and proportion of subjects with extra-nasal symptoms. Modified SNOT-22 self questionnaire: 6-modalities scale

Number of extra-nasal symptoms per subject. Modified SNOT-22 self questionnaire: 6-modalities scale

Evolution of extra-nasal symptoms intensity. Modified SNOT-22 self questionnaire: 6-modalities scale

Evolution of eyes symptoms intensity for allergic rhinitis sufferers. Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ):7-point Likert scale

Evolution of modified SNOT-22 domains. Modified SNOT-22 self-questionnaire: 6-modalities scale

Evolution of modified SNOT-22 global score. Modified SNOT-22 self-questionnaire: 6-modalities scale

Evolution of cough, snoring, wake up at night. Snoring, wake up at night (due to symptoms), cough frequency scale: 7-modalities rating scale

Number and proportion of subjects with acute respiratory infection. Multiple-choice question regarding acute respiratory infection including the start date of the symptoms.

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.

Number and proportion of subjects with asthma episodes/exacerbations (for allergic rhinitis sufferers).

Open question whose unit measurement is in number of episodes.

Evolution of nasal breathing score. Nasal breathing difficulty scale: 6-modalities scale

Evolution in modified SNOT-22 quality of life items. Modified SNOT-22 self-questionnaire: 6-modalities intensity Likert scale

Evolution in loss of energy. 4-modalities rating energy scale

Evolution of well-being and global health status. 0-10 VAS scale

Evolution of symptom interference with daily activities. 5-modalities rating scale

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.

Number of days with sickness / nasal symptoms. Open question whose unit of measurement is in number of days

Number and percentage of subjects with sickness days . Open question whose unit of measurement is in number of days

Number of missed days (work, school, daycare). Open question whose unit of measurement is in number of days

Number and percentage of subjects with missed days (work, school, daycare). Open question whose unit of measurement is in number of days

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

Number and percentage of parents with missed days (work, activities). Open question whose unit of measurement is in number of days

Number of days with impaired family/parental quality of life. Family/parental quality of life scale : 6-modalities rating scale

Number and percentage of parents/family with impaired quality of life. Family/parental quality of life scale: 6 modalities rating scale

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

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

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.

Evolution of allergic rhinitis treatment for allergic rhinitis sufferers. 3-modalities scale

Number and percentage of subjects with severe symptoms intensity. Modified SNOT-22 self-questionnaire: 6-modalities intensity Likert scale

Number and percentage of subjects with severe extra-nasal symptoms intensity. Modified SNOT-22 self-questionnaire: 6-modalities intensity Likert scale

Number and percentage of subjects with severe eyes symptom intensity. Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scale: 7-point Likert scale

Number and percentage of subjects with occurence of complications. Multiple-choice question.

Evolution of asthma symptoms frequency for asthma sufferers. 7-modalities frequency scale

Number and percentage of subjects with asthma episodes/exacerbation for asthma sufferers.

Open question

Evolution of asthma symptoms intensity for asthma sufferers. 7-modalities scale

Number and percentage of subjects consulting a HCP. Collection of unplanned HCP consultations because of nasal/respiratory symptoms

Number and percentage of hospitalized subjects. Collection of hospitalizations due to nasal/respiratory symptoms

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

Duration of improved nasal breathing. 7-modalities questionnaire

Daily average time between two consecutive nasal washes. Open question whose unit of measurement is in hours

Number and percentage of subjects with improved effectiveness of their usual allergic rhinitis treatment.

7-modalities questionnaire

Number of nasal wash per day and Number of days of use per week . 8-modalities posology questionnaire

Moments of use of the nasal spray during the day. 7-modalities multiple choice question

Moments of use versus medications. Co-usage questionnaire.

Occasion of use during the prevention phase. Multiple-choice question

Complementary usage of a baby nasal aspirator. 7-modalities frequency scale

Child's autonomy in using the nasal spray. Multiple-choice question

Number and percentage of subjects satisfied with the use of the nasal spray. 5-modalities satisfaction scale.

Perceived sensation after application. 5-modalities sensory scale.

Global perceived effectiveness of the nasal spray. 6-modalities rating scale

Practicality of the product, easiness to use. 6-modalities technical performance agreement scale.

Number and percentage of subjects with willingness to reuse, willingness to recommend the nasal spray.

4-modalities scale

Usefulness of the educational content (tutorial and tips). Multiple choice satisfaction questionnaire.

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

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).