Allergic RhinitisNCT06104332
PMCF to Assess Real-life Usage Effectiveness, Safety and Patient Satisfaction of a Range of Hypertonic Seawater-based Decongestant Nasal Sprays
An observational study of Allergic Rhinitis and URTI, run by Laboratoire de la Mer at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Allergic Rhinitis, URTI
- What is being tested?
- ProRhinel Naturel spray nasal/ Allergic rhinitis, ProRhinel EXTRA Eucalyptus spray nasal and RESPIMER Enfant
- Type of treatment
- Medical device
- How many people
- 534 participants
- Where
- 2 sitesFrance
- Study dates
- 4 Nov 2023to 25 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: General population coming to pharmacy for spontaneous purchase of a hypertonic seawater-based decongestant nasal spray for URTI or allergic rhinitis.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
- Conditions
- Allergic Rhinitis, URTI
- Being tested
- ProRhinel Naturel spray nasal/ Allergic rhinitis, ProRhinel EXTRA Eucalyptus spray nasal, RESPIMER Enfant, Phytosun Aroms spray nasal MAX, PHYSIOMER RHUME TRIPLE ACTION
- Keywords
- Medical device, Hypertonic seawater-based nasal spray
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 nasalDevice
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
| Study group | Role | What they receive |
|---|---|---|
| ProRhinel Naturel spray nasal/ Allergic Rhinitis | Not described Receives: Device: ProRhinel Naturel spray nasal/ Allergic rhinitis | |
| ProRhinel Naturel spray nasal/ URTI | Not described Receives: Device: ProRhinel Naturel spray nasal/ URTI | |
| ProRhinel EXTRA Eucalyptus spray nasal/ URTI | Not described Receives: Device: ProRhinel EXTRA Eucalyptus spray nasal | |
| RESPIMER Enfant/ URTI | Not described Receives: Device: RESPIMER Enfant | |
| Phytosun Aroms spray nasal MAX/ URTI | Not described Receives: Device: Phytosun Aroms spray nasal MAX | |
| PHYSIOMER RHUME TRIPLE ACTION/ URTI | Not described Receives: Device: PHYSIOMER RHUME TRIPLE ACTION | |
| Phytosun Aroms spray nasal decongestionnant/ URTI | Not described Receives: Device: Phytosun Aroms spray nasal decongestionnant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: AR: 7 days
Secondary outcomes (20)
Effectiveness to improve overall nasal symptoms (daytime)
URTI: Assess effectiveness (daytime) to improve overall nasal symptoms in real world usage (6-point Likert scale)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: AR: Day 0 - Day 21
Relief of nasal symptoms
AR : assessment of nasal symptoms relief (7-point Likert scale)
Measured: AR: Day 1 - Day 21
Relief of nasal symptoms
URTI: assessment of nasal symptoms relief (7-point Likert scale)
Measured: URTI: Day 1 - Day 14
Onset of action & Duration
URTI: Assess Onset of action \& Duration (2 closed questions)
Measured: URTI: Day 0 - Day 14
Onset of action & Duration
AR: Assess Onset of action \& Duration (2 closed questions)
Measured: AR: Day 0 - Day 21
Safety of the medical device
URTI: occurence of incidents and deficiencies
Measured: URTI: Day 0 - Day 14
Tolerance
URTI: 1 question (numeric scale : 0-10)
Measured: URTI: Day 14
Safety of the medical device
AR: occurence of incidents and deficiencies
Measured: AR: Day 0 - Day 21
Tolerance
AR: 1 question (numeric scale: 0-10)
Measured: AR: Day 10 + Day 21
Usage
URTI: number of day of use, number of use/ day, number of puff/ nostril, moment of use
Measured: URTI: Day 0 - Day 14
Usage
AR: number of day of use, number of use/ day, number of puff/ nostril, moment of use
Measured: AR: Day 0 - Day 21
Patient satisfaction
URTI: 10 questions on Satisfaction (numeric scale: 0-10)
Measured: URTI: Day 14
Patient satisfaction
AR: 10 questions on Satisfaction (numeric scale: 0-10)
Measured: AR: Day 10 + Day 21
Sensory profile
URTI: 4 questions on sensory profile (numeric scale: 0-10)
Measured: URTI: Day 14
Sensory profile
AR: 4 questions on sensory profile (numeric scale: 0-10)
Measured: AR: Day 10 + Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start4 Nov 2023
- Primary completion13 Feb 2025
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 534 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoire de la Mer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104332
- Sponsor's protocol ID
- PMCF Hyper Mini
- Status last verified
- Mar 2025
- First submitted
- 23 Oct 2023
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Clinical Investigation to Assess Real-life Usage Effectiveness, Safety and Patient Satisfaction of a Range of Hypertonic Seawater-based Decongestant Nasal Sprays
- ClinicalTrials.gov ID
- NCT06104332
- Acronym / sponsor ID
- PMCF Hyper Mini
- Conditions
- Allergic Rhinitis, URTI
- Keywords
- Medical device, Hypertonic seawater-based nasal spray
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 534 participants (actual)
- Lead sponsor
- Laboratoire de la MerIndustry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Study start
- 4 Nov 2023 (actual)
- Primary completion
- 13 Feb 2025 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- General population coming to pharmacy for spontaneous purchase of a hypertonic seawater-based decongestant nasal spray for URTI or allergic rhinitis.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProRhinel Naturel spray nasal/ Allergic rhinitisProRhinel Naturel spray nasal: 21 days; 1 spray per nostril; 3 to 6 times per day | Device | ProRhinel Naturel spray nasal/ Allergic Rhinitis |
| ProRhinel EXTRA Eucalyptus spray nasalProRhinel EXTRA Eucalyptus spray nasal: until resolution of symptoms (period of 14 days maximum) ; 2 to 3 sprays per nostril; 6 times per day maximum | Device | ProRhinel EXTRA Eucalyptus spray nasal/ URTI |
| RESPIMER EnfantRESPIMER Enfant: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 4 times per day maximum | Device | RESPIMER Enfant/ URTI |
| Phytosun Aroms spray nasal MAXPhytosun Aroms spray nasal MAX: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; up to 4-6 times per day | Device | Phytosun Aroms spray nasal MAX/ URTI |
| PHYSIOMER RHUME TRIPLE ACTIONPHYSIOMER RHUME TRIPLE ACTION: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; up to 4-6 times per day | Device | PHYSIOMER RHUME TRIPLE ACTION/ URTI |
| Phytosun Aroms spray nasal decongestionnantPhytosun Aroms spray nasal decongestionnant : until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 6 times per day maximum | Device | Phytosun Aroms spray nasal decongestionnant/ URTI |
| ProRhinel Naturel spray nasal/ URTIProRhinel Naturel spray nasal: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 3 to 6 times per day | Device | ProRhinel Naturel spray nasal/ URTI |
Primary outcome
URTI population : Effectiveness to improve nasal congestion
Time frame: 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
Time frame: 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
20 secondary outcomes
Effectiveness to improve overall nasal symptoms (daytime)
Time frame: URTI: Day 0 - Day 14
Effectiveness to improve overall nasal symptoms (daytime)
Time frame: AR: Day 0 - Day 21
Effectiveness to improve overall nasal symptoms (night-time)
Time frame: URTI: Day 0 - Day 14
Effectiveness to improve overall nasal symptoms (night-time)
Time frame: AR: Day 0 - Day 21
Effectiveness to improve quality of life
Time frame: URTI: Day 0 - Day 14
Effectiveness to improve quality of life
Time frame: AR: Day 0 - Day 21
Relief of nasal symptoms
Time frame: AR: Day 1 - Day 21
Relief of nasal symptoms
Time frame: URTI: Day 1 - Day 14
Onset of action & Duration
Time frame: URTI: Day 0 - Day 14
Onset of action & Duration
Time frame: AR: Day 0 - Day 21
Safety of the medical device
Time frame: URTI: Day 0 - Day 14
Tolerance
Time frame: URTI: Day 14
Safety of the medical device
Time frame: AR: Day 0 - Day 21
Tolerance
Time frame: AR: Day 10 + Day 21
Usage
Time frame: URTI: Day 0 - Day 14
Usage
Time frame: AR: Day 0 - Day 21
Patient satisfaction
Time frame: URTI: Day 14
Patient satisfaction
Time frame: AR: Day 10 + Day 21
Sensory profile
Time frame: URTI: Day 14
Sensory profile
Time frame: AR: Day 10 + Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis and URTI, run by Laboratoire de la Mer at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
URTI population : Effectiveness to improve nasal congestion (time frame: URTI: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.