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

Last updated: March 6, 2025
Sponsor: Laboratoire de la Mer
Overall Status: Completed

Phase

N/A

Condition

Acute Rhinitis

Common Cold

Allergies & Asthma

Treatment

Phytosun Aroms spray nasal decongestionnant

Phytosun Aroms spray nasal MAX

ProRhinel EXTRA Eucalyptus spray nasal

Clinical Study ID

NCT06104332
PMCF Hyper Mini
  • Ages > 3
  • All Genders

Study 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

Inclusion Criteria:

  • Subject coming to pharmacy for spontaneous purchase of one of the medical deviceunder investigation.

  • Subject willing to buy one of the medical device under investigation followingadvice 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 tofill-in questionnaire himself.

  • Subject able to give inform consent.

Exclusion

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 ofanother clinical study.

  • Subject already included once in this study or having a family member alreadyincluded in this study for the same indication.

  • Vulnerable subject (except children, pregnant and breastfeeding women).

Study Design

Total Participants: 534
Treatment Group(s): 7
Primary Treatment: Phytosun Aroms spray nasal decongestionnant
Phase:
Study Start date:
November 04, 2023
Estimated Completion Date:
February 25, 2025

Connect with a study center

  • Alexandra Crevecoeur

    Honfleur,
    France

    Site Not Available

  • Annie Le Gall

    Vern-sur-Seiche,
    France

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.