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

Laboratoire de la Mer534 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

534

Conditions

Allergic Rhinitis URTI

Interventions

ProRhinel Naturel spray nasal/ Allergic rhinitisDEVICE

ProRhinel Naturel spray nasal: 21 days; 1 spray per nostril; 3 to 6 times per day

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

RESPIMER EnfantDEVICE

RESPIMER Enfant: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 4 times per day maximum

Phytosun Aroms spray nasal MAXDEVICE

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

PHYSIOMER RHUME TRIPLE ACTIONDEVICE

PHYSIOMER RHUME TRIPLE ACTION: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; up to 4-6 times per day

Phytosun Aroms spray nasal decongestionnantDEVICE

Phytosun Aroms spray nasal decongestionnant : until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 6 times per day maximum

ProRhinel Naturel spray nasal/ URTIDEVICE

ProRhinel Naturel spray nasal: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 3 to 6 times per day

Eligibility

Sex: ALLMin age: 3 Years

Medical Language ↔ Plain English

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).

Locations (2)

Alexandra Crevecoeur

Honfleur, France

Annie Le Gall

Vern-sur-Seiche, France

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: AR: 7 days

Secondary Outcomes

Effectiveness to improve overall nasal symptoms (daytime)

URTI: Assess effectiveness (daytime) to improve overall nasal symptoms in real world usage (6-point Likert scale)

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: AR: Day 0 - Day 21

Relief of nasal symptoms

AR : assessment of nasal symptoms relief (7-point Likert scale)

Time frame: AR: Day 1 - Day 21

Relief of nasal symptoms

URTI: assessment of nasal symptoms relief (7-point Likert scale)

Time frame: URTI: Day 1 - Day 14

Onset of action & Duration

URTI: Assess Onset of action \& Duration (2 closed questions)

Time frame: URTI: Day 0 - Day 14

Onset of action & Duration

AR: Assess Onset of action \& Duration (2 closed questions)

Time frame: AR: Day 0 - Day 21

Safety of the medical device

URTI: occurence of incidents and deficiencies

Time frame: URTI: Day 0 - Day 14

Tolerance

URTI: 1 question (numeric scale : 0-10)

Time frame: URTI: Day 14

Safety of the medical device

AR: occurence of incidents and deficiencies

Time frame: AR: Day 0 - Day 21

Tolerance

AR: 1 question (numeric scale: 0-10)

Time frame: AR: Day 10 + Day 21

Usage

URTI: number of day of use, number of use/ day, number of puff/ nostril, moment of use

Time frame: URTI: Day 0 - Day 14

Usage

AR: number of day of use, number of use/ day, number of puff/ nostril, moment of use

Time frame: AR: Day 0 - Day 21

Patient satisfaction

URTI: 10 questions on Satisfaction (numeric scale: 0-10)

Time frame: URTI: Day 14

Patient satisfaction

AR: 10 questions on Satisfaction (numeric scale: 0-10)

Time frame: AR: Day 10 + Day 21

Sensory profile

URTI: 4 questions on sensory profile (numeric scale: 0-10)

Time frame: URTI: Day 14

Sensory profile

AR: 4 questions on sensory profile (numeric scale: 0-10)

Time frame: AR: Day 10 + Day 21

Data from ClinicalTrials.gov

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