Status:
COMPLETED
PMCF to Assess Real-life Usage Effectiveness, Safety and Patient Satisfaction of a Range of Hypertonic Seawater-based Decongestant Nasal Sprays
Lead Sponsor:
Laboratoire de la Mer
Collaborating Sponsors:
Slb Pharma
Conditions:
Allergic Rhinitis
URTI
Eligibility:
All Genders
3+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
November 4 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 25 2025
Estimated Enrollment :
534 Patients enrolled
Trial Details
Trial ID
NCT06104332
Start Date
November 4 2023
End Date
February 25 2025
Last Update
March 11 2025
Active Locations (2)
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1
Alexandra Crevecoeur
Honfleur, France
2
Annie Le Gall
Vern-sur-Seiche, France