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

NCT06104332 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 534

Last updated 2025-03-11

No results posted yet for this 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.

Conditions

  • Allergic Rhinitis
  • URTI

Interventions

DEVICE

ProRhinel Naturel spray nasal/ Allergic rhinitis

ProRhinel Naturel spray nasal: 21 days; 1 spray per nostril; 3 to 6 times per day

DEVICE

ProRhinel EXTRA Eucalyptus spray nasal

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

DEVICE

RESPIMER Enfant

RESPIMER Enfant: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 4 times per day maximum

DEVICE

Phytosun Aroms spray nasal MAX

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

DEVICE

PHYSIOMER RHUME TRIPLE ACTION

PHYSIOMER RHUME TRIPLE ACTION: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; up to 4-6 times per day

DEVICE

Phytosun Aroms spray nasal decongestionnant

Phytosun Aroms spray nasal decongestionnant : until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 6 times per day maximum

DEVICE

ProRhinel Naturel spray nasal/ URTI

ProRhinel Naturel spray nasal: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 3 to 6 times per day

Sponsors & Collaborators

  • Slb Pharma

    collaborator OTHER

  • Laboratoire de la Mer

    lead INDUSTRY

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-04
Primary Completion
2025-02-13
Completion
2025-02-25

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06104332 on ClinicalTrials.gov