PMCF to Assess Real-life Usage Effectiveness, Safety and Patient Satisfaction of a Range of Hypertonic Seawater-based Decongestant Nasal Sprays
NCT ID: NCT06104332
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
534 participants
OBSERVATIONAL
2023-11-04
2025-02-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms
NCT07262450
Performance and Safety Assessment of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert in Patient With Acute Rhinitis Associated With Nasal Obstruction
NCT06580210
Study on Hypertonic Saline Nasal Spray
NCT02100605
Efficacy of Two Nasal Products Based on Diluted Seawater in the Treatment of Upper Respiratory Infections/Conditions
NCT06498843
Efficacy of Two Nasal Products for Decongestion and Mucus Fluidification
NCT04230993
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ProRhinel Naturel spray nasal/ Allergic Rhinitis
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
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
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
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
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
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
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ProRhinel Naturel spray nasal/ Allergic rhinitis
ProRhinel Naturel spray nasal: 21 days; 1 spray per nostril; 3 to 6 times per day
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
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
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
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
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/ URTI
ProRhinel Naturel spray nasal: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 3 to 6 times per day
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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).
3 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Slb Pharma
OTHER
Laboratoire de la Mer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alexandra Crevecoeur
Honfleur, , France
Annie Le Gall
Vern-sur-Seiche, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PMCF Hyper Mini
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.