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

Laboratoire de la Mer2 sites in 1 country534 target enrollmentNovember 4, 2023

ConditionsAllergic Rhinitis URTI

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Allergic Rhinitis
Sponsor: Laboratoire de la Mer
Enrollment: 534
Locations: 2
Primary Endpoint: URTI population : Effectiveness to improve nasal congestion
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 4, 2023

End Date

February 25, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Laboratoire de la Mer

Responsible Party

Sponsor

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).

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

Effectiveness to improve overall nasal symptoms (night-time)(AR: Day 0 - Day 21)
Usage(AR: Day 0 - Day 21)
Tolerance(AR: Day 10 + Day 21)
Safety of the medical device(AR: Day 0 - Day 21)
Patient satisfaction(AR: Day 10 + Day 21)
Sensory profile(AR: Day 10 + Day 21)
Effectiveness to improve overall nasal symptoms (daytime)(AR: Day 0 - Day 21)
Effectiveness to improve quality of life(AR: Day 0 - Day 21)
Relief of nasal symptoms(URTI: Day 1 - Day 14)
Onset of action & Duration(AR: Day 0 - Day 21)