CompletedNCT06104332Updated Mar 11, 2025

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

An observational study in Allergic Rhinitis and URTI, sponsored by Laboratoire de la Mer. Completed at 2 sites in France. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2025-03-11.

Sponsored by Laboratoire de la Mer · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 534
Ages: 3 Years and older
Sex: All

Study 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.

Conditions studied

Allergic Rhinitis
URTI

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Keywords

Medical device
Hypertonic seawater-based nasal spray

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 534 is above the median of 141 across 172 observational studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Laboratoire de la Mer is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 3 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
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.

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

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

Observational model: Cohort
Time perspective: Prospective
Enrollment: 534 participants (actual)
Patient registry: No

Groups and cohorts

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

Interventions

DeviceProRhinel Naturel spray nasal/ Allergic rhinitis
ProRhinel Naturel spray nasal: 21 days; 1 spray per nostril; 3 to 6 times per day
DeviceProRhinel 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
DeviceRESPIMER Enfant
RESPIMER Enfant: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 4 times per day maximum
DevicePhytosun 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
DevicePHYSIOMER 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
DevicePhytosun 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
DeviceProRhinel 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

What researchers measure

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

Study locations

2 sites

Alexandra Crevecoeur
Honfleur, France
Annie Le Gall
Vern-sur-Seiche, France

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06104332
Lead sponsor: Laboratoire de la Mer
Collaborators: Slb Pharma
Responsible party: Sponsor
First posted: Oct 27, 2023
Start date: Nov 4, 2023
Primary completion: Feb 13, 2025
Completion: Feb 25, 2025
Last update: Mar 11, 2025

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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