PMCF to Assess Real-life Usage Effectiveness, Safety and Patient Satisfaction of a Range of Hypertonic Seawater-based Decongestant Nasal Sprays

Study Overview
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Brief Summary
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The brief of this observational study is to evaluate usage, efficacy, safety and patient satisfaction of a range of hypertonic seawater-based decongestant nasal sprays in general population. The main questions it aims to answer are: Usage, Efficacy, Safety, Satisfaction, in real-life usage with children, adults and pregnant or breastfeeding women. Participants will use the nasal spray as usual habits and complete daily questionnaires.

Official Title
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Post-marketing Clinical Investigation to Assess Real-life Usage Effectiveness, Safety and Patient Satisfaction of a Range of Hypertonic Seawater-based Decongestant Nasal Sprays

Conditions
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Allergic Rhinitis, URTI

Intervention / Treatment
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* Device: ProRhinel Naturel spray nasal/ Allergic rhinitis
* Device: ProRhinel EXTRA Eucalyptus spray nasal
* Device: RESPIMER Enfant
* Device: Phytosun Aroms spray nasal MAX
* Device: PHYSIOMER RHUME TRIPLE ACTION
* Device: Phytosun Aroms spray nasal decongestionnant
* Device: ProRhinel Naturel spray nasal/ URTI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject coming to pharmacy for spontaneous purchase of one of the medical device under investigation. Subject willing to buy one of the medical device under investigation following advice from pharmacist, general practitioner or any other health care professionals. Adult and children from 3 years old in compliance with the information for use. Subject presenting moderate nasal congestion or more. Subject agreeing to follow the study requirements during the whole study period. Subject having daily access to internet in order to answer online questionnaire. Subject able to understand verbal and written local language and in capacity to fill-in questionnaire himself. Subject able to give inform consent. Exclusion Criteria: Subject with contraindications according to the information for use. Hypersensitivity or know allergy to any component of the product. Subject taking part in another clinical study or being in the exclusion period of another clinical study. Subject already included once in this study or having a family member already included in this study for the same indication. Vulnerable subject (except children, pregnant and breastfeeding women).

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ProRhinel Naturel spray nasal/ Allergic Rhinitis<br> | Device: ProRhinel Naturel spray nasal/ Allergic rhinitis<br>* ProRhinel Naturel spray nasal: 21 days; 1 spray per nostril; 3 to 6 times per day<br>|
| ProRhinel Naturel spray nasal/ URTI<br> | Device: ProRhinel Naturel spray nasal/ URTI<br>* ProRhinel Naturel spray nasal: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 3 to 6 times per day<br>|
| ProRhinel EXTRA Eucalyptus spray nasal/ URTI<br> | Device: ProRhinel EXTRA Eucalyptus spray nasal<br>* ProRhinel EXTRA Eucalyptus spray nasal: until resolution of symptoms (period of 14 days maximum) ; 2 to 3 sprays per nostril; 6 times per day maximum<br>|
| RESPIMER Enfant/ URTI<br> | Device: RESPIMER Enfant<br>* RESPIMER Enfant: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 4 times per day maximum<br>|
| Phytosun Aroms spray nasal MAX/ URTI<br> | Device: Phytosun Aroms spray nasal MAX<br>* Phytosun Aroms spray nasal MAX: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; up to 4-6 times per day<br>|
| PHYSIOMER RHUME TRIPLE ACTION/ URTI<br> | Device: PHYSIOMER RHUME TRIPLE ACTION<br>* PHYSIOMER RHUME TRIPLE ACTION: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; up to 4-6 times per day<br>|
| Phytosun Aroms spray nasal decongestionnant/ URTI<br> | Device: Phytosun Aroms spray nasal decongestionnant<br>* Phytosun Aroms spray nasal decongestionnant : until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 6 times per day maximum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| URTI population : Effectiveness to improve nasal congestion | URTI: Assess effectiveness to improve nasal congestion in real world usage (6-point Likert scale) 6-point-Likert scale: 0 (None) - 1 (Very mild) - 2 (Mild) - 3 (Moderate) - 4 (Strong) - 5 (Very strong). Higher score means a worse outcome | URTI: 3 days | 
| AR population: Effectiveness to improve nasal congestion | Allergic Rhinitis (AR) : Assess effectiveness to improve nasal congestion in real world usage (6-point Likert scale) 6-point-Likert scale: 0 (None) - 1 (Very mild) - 2 (Mild) - 3 (Moderate) - 4 (Strong) - 5 (Very strong). Higher score means a worse outcome | AR: 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness to improve overall nasal symptoms (daytime) | URTI: Assess effectiveness (daytime) to improve overall nasal symptoms in real world usage (6-point Likert scale) | URTI: Day 0 - Day 14 | 
| Effectiveness to improve overall nasal symptoms (daytime) | AR: Assess effectiveness (daytime) to improve overall nasal symptoms in real world usage (6-point Likert scale) | AR: Day 0 - Day 21 | 
| Effectiveness to improve overall nasal symptoms (night-time) | URTI: Assess effectiveness (night-time) to improve overall nasal symptoms in real world usage (6-point Likert scale) | URTI: Day 0 - Day 14 | 
| Effectiveness to improve overall nasal symptoms (night-time) | AR: Assess effectiveness (night-time) to improve overall nasal symptoms in real world usage | AR: Day 0 - Day 21 | 
| Effectiveness to improve quality of life | URTI: Assess effectiveness to improve quality of life in real world usage (RQLQ self-administered questionnaire) | URTI: Day 0 - Day 14 | 
| Effectiveness to improve quality of life | AR: Assess effectiveness to improve quality of life in real world usage (RQLQ self-administered questionnaire) | AR: Day 0 - Day 21 | 
| Relief of nasal symptoms | AR : assessment of nasal symptoms relief (7-point Likert scale) | AR: Day 1 - Day 21 | 
| Relief of nasal symptoms | URTI: assessment of nasal symptoms relief (7-point Likert scale) | URTI: Day 1 - Day 14 | 
| Onset of action & Duration | URTI: Assess Onset of action & Duration (2 closed questions) | URTI: Day 0 - Day 14 | 
| Onset of action & Duration | AR: Assess Onset of action & Duration (2 closed questions) | AR: Day 0 - Day 21 | 
| Safety of the medical device | URTI: occurence of incidents and deficiencies | URTI: Day 0 - Day 14 | 
| Tolerance | URTI: 1 question (numeric scale : 0-10) | URTI: Day 14 | 
| Safety of the medical device | AR: occurence of incidents and deficiencies | AR: Day 0 - Day 21 | 
| Tolerance | AR: 1 question (numeric scale: 0-10) | AR: Day 10 + Day 21 | 
| Usage | URTI: number of day of use, number of use/ day, number of puff/ nostril, moment of use | URTI: Day 0 - Day 14 | 
| Usage | AR: number of day of use, number of use/ day, number of puff/ nostril, moment of use | AR: Day 0 - Day 21 | 
| Patient satisfaction | URTI: 10 questions on Satisfaction (numeric scale: 0-10) | URTI: Day 14 | 
| Patient satisfaction | AR: 10 questions on Satisfaction (numeric scale: 0-10) | AR: Day 10 + Day 21 | 
| Sensory profile | URTI: 4 questions on sensory profile (numeric scale: 0-10) | URTI: Day 14 | 
| Sensory profile | AR: 4 questions on sensory profile (numeric scale: 0-10) | AR: Day 10 + Day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertonic seawater-based nasal spray, Medical device