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

Laboratoire de la Mer

Status: Completed

Conditions: Allergic Rhinitis; URTI

Treatments: Device: Phytosun Aroms spray nasal decongestionnant; Device: Phytosun Aroms spray nasal MAX; Device: RESPIMER Enfant; Device: ProRhinel Naturel spray nasal/ URTI; Device: PHYSIOMER RHUME TRIPLE ACTION; Device: ProRhinel EXTRA Eucalyptus spray nasal; Device: ProRhinel Naturel spray nasal/ Allergic rhinitis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06104332

PMCF Hyper Mini

Details and patient eligibility

About

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.

Enrollment: 534 patients

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

534 participants in 7 patient groups

ProRhinel Naturel spray nasal/ Allergic Rhinitis

Treatment:

Device: ProRhinel Naturel spray nasal/ Allergic rhinitis

ProRhinel Naturel spray nasal/ URTI

Treatment:

Device: ProRhinel Naturel spray nasal/ URTI

ProRhinel EXTRA Eucalyptus spray nasal/ URTI

Treatment:

Device: ProRhinel EXTRA Eucalyptus spray nasal

RESPIMER Enfant/ URTI

Treatment:

Device: RESPIMER Enfant

Phytosun Aroms spray nasal MAX/ URTI

Treatment:

Device: Phytosun Aroms spray nasal MAX

PHYSIOMER RHUME TRIPLE ACTION/ URTI

Treatment:

Device: PHYSIOMER RHUME TRIPLE ACTION

Phytosun Aroms spray nasal decongestionnant/ URTI

Treatment:

Device: Phytosun Aroms spray nasal decongestionnant