PMCF to Assess Real-life Usage Effectiveness, Safety and Patient Satisfaction of a Range of Hypertonic Seawater-based Decongestant Nasal Sprays
Post-marketing Clinical Investigation to Assess Real-life Usage Effectiveness, Safety and Patient Satisfaction of a Range of Hypertonic Seawater-based Decongestant Nasal Sprays
1 other identifier
observational
534
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2023
CompletedFirst Posted
Study publicly available on registry
October 27, 2023
CompletedStudy Start
First participant enrolled
November 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2025
CompletedMarch 11, 2025
March 1, 2025
1.3 years
October 23, 2023
March 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
AR: 7 days
Secondary Outcomes (20)
Effectiveness to improve overall nasal symptoms (daytime)
URTI: Day 0 - Day 14
Effectiveness to improve overall nasal symptoms (daytime)
AR: Day 0 - Day 21
Effectiveness to improve overall nasal symptoms (night-time)
URTI: Day 0 - Day 14
Effectiveness to improve overall nasal symptoms (night-time)
AR: Day 0 - Day 21
Effectiveness to improve quality of life
URTI: Day 0 - Day 14
- +15 more secondary outcomes
Study Arms (7)
ProRhinel Naturel spray nasal/ Allergic Rhinitis
ProRhinel Naturel spray nasal/ URTI
ProRhinel EXTRA Eucalyptus spray nasal/ URTI
RESPIMER Enfant/ URTI
Phytosun Aroms spray nasal MAX/ URTI
PHYSIOMER RHUME TRIPLE ACTION/ URTI
Phytosun Aroms spray nasal decongestionnant/ URTI
Interventions
ProRhinel Naturel spray nasal: 21 days; 1 spray per nostril; 3 to 6 times per day
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: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 4 times per day maximum
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: 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 : until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 6 times per day maximum
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
General population coming to pharmacy for spontaneous purchase of a hypertonic seawater-based decongestant nasal spray for URTI or allergic rhinitis.
You may qualify if:
- 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.
You may not qualify if:
- Subject with contraindications according to the information for use.
- Hypersensitivity or know allergy to any component of the product.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laboratoire de la Merlead
- Slb Pharmacollaborator
Study Sites (2)
Alexandra Crevecoeur
Honfleur, France
Annie Le Gall
Vern-sur-Seiche, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2023
First Posted
October 27, 2023
Study Start
November 4, 2023
Primary Completion
February 13, 2025
Study Completion
February 25, 2025
Last Updated
March 11, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share