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| Name | Class |
|---|---|
| Slb Pharma | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ProRhinel Naturel spray nasal/ Allergic Rhinitis |
| ||
| ProRhinel Naturel spray nasal/ URTI |
| ||
| ProRhinel EXTRA Eucalyptus spray nasal/ URTI |
| ||
| RESPIMER Enfant/ URTI |
| ||
| Phytosun Aroms spray nasal MAX/ URTI |
| ||
| PHYSIOMER RHUME TRIPLE ACTION/ URTI |
| ||
| Phytosun Aroms spray nasal decongestionnant/ URTI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProRhinel Naturel spray nasal/ Allergic rhinitis | Device | ProRhinel Naturel spray nasal: 21 days; 1 spray per nostril; 3 to 6 times per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| URTI population : Effectiveness to improve nasal congestion | 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 | URTI: 3 days |
| AR population: Effectiveness to improve nasal congestion | 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 | AR: 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness to improve overall nasal symptoms (daytime) | URTI: Assess effectiveness (daytime) to improve overall nasal symptoms in real world usage (6-point Likert scale) | URTI: Day 0 - Day 14 |
| Effectiveness to improve overall nasal symptoms (daytime) |
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Inclusion Criteria:
Exclusion Criteria:
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General population coming to pharmacy for spontaneous purchase of a hypertonic seawater-based decongestant nasal spray for URTI or allergic rhinitis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandra Crevecoeur | Honfleur | France | ||||
| Annie Le Gall |
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| ProRhinel EXTRA Eucalyptus spray nasal | Device | 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 |
|
| RESPIMER Enfant | Device | RESPIMER Enfant: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 4 times per day maximum |
|
| Phytosun Aroms spray nasal MAX | Device | 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 |
|
| PHYSIOMER RHUME TRIPLE ACTION | Device | PHYSIOMER RHUME TRIPLE ACTION: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; up to 4-6 times per day |
|
| Phytosun Aroms spray nasal decongestionnant | Device | Phytosun Aroms spray nasal decongestionnant : until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 6 times per day maximum |
|
| ProRhinel Naturel spray nasal/ URTI | Device | ProRhinel Naturel spray nasal: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 3 to 6 times per day |
|
AR: Assess effectiveness (daytime) to improve overall nasal symptoms in real world usage (6-point Likert scale) |
| AR: Day 0 - Day 21 |
| Effectiveness to improve overall nasal symptoms (night-time) | URTI: Assess effectiveness (night-time) to improve overall nasal symptoms in real world usage (6-point Likert scale) | URTI: Day 0 - Day 14 |
| Effectiveness to improve overall nasal symptoms (night-time) | AR: Assess effectiveness (night-time) to improve overall nasal symptoms in real world usage | AR: Day 0 - Day 21 |
| Effectiveness to improve quality of life | URTI: Assess effectiveness to improve quality of life in real world usage (RQLQ self-administered questionnaire) | URTI: Day 0 - Day 14 |
| Effectiveness to improve quality of life | AR: Assess effectiveness to improve quality of life in real world usage (RQLQ self-administered questionnaire) | AR: Day 0 - Day 21 |
| Relief of nasal symptoms | AR : assessment of nasal symptoms relief (7-point Likert scale) | AR: Day 1 - Day 21 |
| Relief of nasal symptoms | URTI: assessment of nasal symptoms relief (7-point Likert scale) | URTI: Day 1 - Day 14 |
| Onset of action & Duration | URTI: Assess Onset of action & Duration (2 closed questions) | URTI: Day 0 - Day 14 |
| Onset of action & Duration | AR: Assess Onset of action & Duration (2 closed questions) | AR: Day 0 - Day 21 |
| Safety of the medical device | URTI: occurence of incidents and deficiencies | URTI: Day 0 - Day 14 |
| Tolerance | URTI: 1 question (numeric scale : 0-10) | URTI: Day 14 |
| Safety of the medical device | AR: occurence of incidents and deficiencies | AR: Day 0 - Day 21 |
| Tolerance | AR: 1 question (numeric scale: 0-10) | AR: Day 10 + Day 21 |
| Usage | URTI: number of day of use, number of use/ day, number of puff/ nostril, moment of use | URTI: Day 0 - Day 14 |
| Usage | AR: number of day of use, number of use/ day, number of puff/ nostril, moment of use | AR: Day 0 - Day 21 |
| Patient satisfaction | URTI: 10 questions on Satisfaction (numeric scale: 0-10) | URTI: Day 14 |
| Patient satisfaction | AR: 10 questions on Satisfaction (numeric scale: 0-10) | AR: Day 10 + Day 21 |
| Sensory profile | URTI: 4 questions on sensory profile (numeric scale: 0-10) | URTI: Day 14 |
| Sensory profile | AR: 4 questions on sensory profile (numeric scale: 0-10) | AR: Day 10 + Day 21 |
| Vern-sur-Seiche |
| France |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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