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

Completed

• Conditions: Allergic Rhinitis; URTI
• Interventions: Device: ProRhinel EXTRA Eucalyptus spray nasal; Device: ProRhinel Naturel spray nasal/ Allergic rhinitis; Device: Phytosun Aroms spray nasal MAX; Device: PHYSIOMER RHUME TRIPLE ACTION; Device: ProRhinel Naturel spray nasal/ URTI; Device: RESPIMER Enfant; Device: Phytosun Aroms spray nasal decongestionnant

• Registration Number: NCT06104332
• Lead Sponsor: Laboratoire de la Mer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-27
• Study Start: 2023-11-04
• Primary Completion: 2025-02-13
• Study Completion: 2025-02-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 534

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ProRhinel EXTRA Eucalyptus spray nasal/ URTI	ProRhinel EXTRA Eucalyptus spray nasal	-
ProRhinel Naturel spray nasal/ Allergic Rhinitis	ProRhinel Naturel spray nasal/ Allergic rhinitis	-
Phytosun Aroms spray nasal MAX/ URTI	Phytosun Aroms spray nasal MAX	-
PHYSIOMER RHUME TRIPLE ACTION/ URTI	PHYSIOMER RHUME TRIPLE ACTION	-
ProRhinel Naturel spray nasal/ URTI	ProRhinel Naturel spray nasal/ URTI	-
RESPIMER Enfant/ URTI	RESPIMER Enfant	-
Phytosun Aroms spray nasal decongestionnant/ URTI	Phytosun Aroms spray nasal decongestionnant	-

Primary Outcome Measures

Name	Time	Method
URTI population : Effectiveness to improve nasal congestion	URTI: 3 days	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
AR population: Effectiveness to improve nasal congestion	AR: 7 days	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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Annie Le Gall; 🇫🇷 Vern-sur-Seiche, France

Alexandra Crevecoeur; 🇫🇷 Honfleur, France