Allergic Rhinitis, URTI
Conditions
Keywords
Medical device, Hypertonic seawater-based nasal spray
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.
Interventions
DEVICEPHYSIOMER 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
DEVICEPhytosun 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
DEVICEProRhinel 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
DEVICEProRhinel Naturel spray nasal/ Allergic rhinitis
ProRhinel Naturel spray nasal: 21 days; 1 spray per nostril; 3 to 6 times per day
DEVICEProRhinel 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
DEVICERESPIMER Enfant
RESPIMER Enfant: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 4 times per day maximum
DEVICEPhytosun 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
Sponsors
Slb Pharma
Laboratoire de la Mer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| URTI population : Effectiveness to improve nasal congestion | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness to improve quality of life | URTI: Day 0 - Day 14 | URTI: Assess effectiveness to improve quality of life in real world usage (RQLQ self-administered questionnaire) |
| Relief of nasal symptoms | AR: Day 1 - Day 21 | AR : assessment of nasal symptoms relief (7-point Likert scale) |
| Onset of action & Duration | URTI: Day 0 - Day 14 | URTI: Assess Onset of action & Duration (2 closed questions) |
| Safety of the medical device | URTI: Day 0 - Day 14 | URTI: occurence of incidents and deficiencies |
| Effectiveness to improve overall nasal symptoms (daytime) | URTI: Day 0 - Day 14 | URTI: Assess effectiveness (daytime) to improve overall nasal symptoms in real world usage (6-point Likert scale) |
| Usage | URTI: Day 0 - Day 14 | URTI: number of day of use, number of use/ day, number of puff/ nostril, moment of use |
| Patient satisfaction | URTI: Day 14 | URTI: 10 questions on Satisfaction (numeric scale: 0-10) |
| Sensory profile | URTI: Day 14 | URTI: 4 questions on sensory profile (numeric scale: 0-10) |
| Tolerance | URTI: Day 14 | URTI: 1 question (numeric scale : 0-10) |
| Effectiveness to improve overall nasal symptoms (night-time) | URTI: Day 0 - Day 14 | URTI: Assess effectiveness (night-time) to improve overall nasal symptoms in real world usage (6-point Likert scale) |
Countries
France
Outcome results
None listed