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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Allergic Rhinitis; URTI
• Intervention / Treatment: Device: ProRhinel Naturel spray nasal/ Allergic rhinitis; Device: ProRhinel Naturel spray nasal/ URTI; 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

• Study Type: Observational
• Enrollment (Estimated): 534

Contacts and Locations

• Study Contact: Name: Ophélie Flageul; Phone Number: 0299121962; Email: o.flageul@slbpharma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

General population coming to pharmacy for spontaneous purchase of a hypertonic seawater-based decongestant nasal spray for URTI or allergic rhinitis.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ProRhinel Naturel spray nasal/ Allergic Rhinitis	Device: ProRhinel Naturel spray nasal/ Allergic rhinitis; ProRhinel Naturel spray nasal: 21 days; 1 spray per nostril; 3 to 6 times per day
ProRhinel Naturel spray nasal/ URTI	Device: ProRhinel Naturel spray nasal/ URTI; ProRhinel Naturel spray nasal: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 3 to 6 times per day
ProRhinel EXTRA Eucalyptus spray nasal/ URTI	Device: ProRhinel EXTRA Eucalyptus spray nasal; 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 Enfant/ URTI	Device: RESPIMER Enfant; RESPIMER Enfant: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 4 times per day maximum
Phytosun Aroms spray nasal MAX/ URTI	Device: Phytosun Aroms spray nasal MAX; 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 ACTION/ URTI	Device: PHYSIOMER RHUME TRIPLE ACTION; 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 decongestionnant/ URTI	Device: Phytosun Aroms spray nasal decongestionnant; Phytosun Aroms spray nasal decongestionnant : until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 6 times per day maximum

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Laboratoire de la Mer
• Collaborators: Slb Pharma

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Medical device; Hypertonic seawater-based nasal spray
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: PMCF Hyper Mini

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No