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

March 6, 2025 updated by: Laboratoire de la Mer

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
534

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
URTI: 3 days
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
AR: 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effectiveness to improve overall nasal symptoms (daytime)
Time Frame: URTI: Day 0 - Day 14
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)
Time Frame: AR: Day 0 - Day 21
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)
Time Frame: URTI: Day 0 - Day 14
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)
Time Frame: AR: Day 0 - Day 21
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
Time Frame: URTI: Day 0 - Day 14
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
Time Frame: AR: Day 0 - Day 21
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
Time Frame: AR: Day 1 - Day 21
AR : assessment of nasal symptoms relief (7-point Likert scale)
AR: Day 1 - Day 21
Relief of nasal symptoms
Time Frame: URTI: Day 1 - Day 14
URTI: assessment of nasal symptoms relief (7-point Likert scale)
URTI: Day 1 - Day 14
Onset of action & Duration
Time Frame: URTI: Day 0 - Day 14
URTI: Assess Onset of action & Duration (2 closed questions)
URTI: Day 0 - Day 14
Onset of action & Duration
Time Frame: AR: Day 0 - Day 21
AR: Assess Onset of action & Duration (2 closed questions)
AR: Day 0 - Day 21
Safety of the medical device
Time Frame: URTI: Day 0 - Day 14
URTI: occurence of incidents and deficiencies
URTI: Day 0 - Day 14
Tolerance
Time Frame: URTI: Day 14
URTI: 1 question (numeric scale : 0-10)
URTI: Day 14
Safety of the medical device
Time Frame: AR: Day 0 - Day 21
AR: occurence of incidents and deficiencies
AR: Day 0 - Day 21
Tolerance
Time Frame: AR: Day 10 + Day 21
AR: 1 question (numeric scale: 0-10)
AR: Day 10 + Day 21
Usage
Time Frame: URTI: Day 0 - Day 14
URTI: number of day of use, number of use/ day, number of puff/ nostril, moment of use
URTI: Day 0 - Day 14
Usage
Time Frame: AR: Day 0 - Day 21
AR: number of day of use, number of use/ day, number of puff/ nostril, moment of use
AR: Day 0 - Day 21
Patient satisfaction
Time Frame: URTI: Day 14
URTI: 10 questions on Satisfaction (numeric scale: 0-10)
URTI: Day 14
Patient satisfaction
Time Frame: AR: Day 10 + Day 21
AR: 10 questions on Satisfaction (numeric scale: 0-10)
AR: Day 10 + Day 21
Sensory profile
Time Frame: URTI: Day 14
URTI: 4 questions on sensory profile (numeric scale: 0-10)
URTI: Day 14
Sensory profile
Time Frame: AR: Day 10 + Day 21
AR: 4 questions on sensory profile (numeric scale: 0-10)
AR: Day 10 + Day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laboratoire de la Mer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Slb Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 4, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 13, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings