Clinical trial NCT06104332: PMCF to Assess Real-life Usage Effectiveness, Safety and Patient Satisfaction of a Range of Hypertonic Seawater-based Decongestant Nasal Sprays
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis
URTI
Keywords: Medical device
Hypertonic seawater-based nasal spray
Lead sponsor: Laboratoire de la Mer
Sponsor class: INDUSTRY
Collaborators: name: Slb Pharma
First posted: 2023-10-27
Enrollment: 534
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: URTI population : Effectiveness to improve nasal congestion
timeFrame: URTI: 3 days
measure: AR population: Effectiveness to improve nasal congestion
timeFrame: AR: 7 days
Secondary outcomes:
measure: Effectiveness to improve overall nasal symptoms (daytime)
timeFrame: URTI: Day 0 - Day 14
measure: Effectiveness to improve overall nasal symptoms (daytime)
timeFrame: AR: Day 0 - Day 21
measure: Effectiveness to improve overall nasal symptoms (night-time)
timeFrame: URTI: Day 0 - Day 14
measure: Effectiveness to improve overall nasal symptoms (night-time)
timeFrame: AR: Day 0 - Day 21
measure: Effectiveness to improve quality of life
timeFrame: URTI: Day 0 - Day 14
measure: Effectiveness to improve quality of life
timeFrame: AR: Day 0 - Day 21
measure: Relief of nasal symptoms
timeFrame: AR: Day 1 - Day 21
measure: Relief of nasal symptoms
timeFrame: URTI: Day 1 - Day 14
measure: Onset of action & Duration
timeFrame: URTI: Day 0 - Day 14
measure: Onset of action & Duration
timeFrame: AR: Day 0 - Day 21
measure: Safety of the medical device
timeFrame: URTI: Day 0 - Day 14
measure: Tolerance
timeFrame: URTI: Day 14
measure: Safety of the medical device
timeFrame: AR: Day 0 - Day 21
measure: Tolerance
timeFrame: AR: Day 10 + Day 21
measure: Usage
timeFrame: URTI: Day 0 - Day 14
measure: Usage
timeFrame: AR: Day 0 - Day 21
measure: Patient satisfaction
timeFrame: URTI: Day 14
measure: Patient satisfaction
timeFrame: AR: Day 10 + Day 21
measure: Sensory profile
timeFrame: URTI: Day 14
measure: Sensory profile
timeFrame: AR: Day 10 + Day 21
Other outcomes:
Locations:
city: Honfleur
country: France
facility: Alexandra Crevecoeur
city: Vern-sur-Seiche
country: France
facility: Annie Le Gall
Study officials:
References: