PMCF to Assess Real-life Usage Effectiveness, Safety and Patient Satisfaction of a Range of Hypertonic Seawater-based Decongestant Nasal Sprays
Study Details
Study Description
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:
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Usage,
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Efficacy,
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Safety,
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ProRhinel Naturel spray nasal/ Allergic Rhinitis
|
Device: ProRhinel Naturel spray nasal/ Allergic rhinitis
ProRhinel Naturel spray nasal: 21 days; 1 spray per nostril; 3 to 6 times per day
|
| ProRhinel Naturel spray nasal/ URTI
|
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
|
| ProRhinel EXTRA Eucalyptus spray nasal/ URTI
|
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
|
| RESPIMER Enfant/ URTI
|
Device: RESPIMER Enfant
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/ URTI
|
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
|
| PHYSIOMER RHUME TRIPLE ACTION/ URTI
|
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
|
| Phytosun Aroms spray nasal decongestionnant/ URTI
|
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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)
- Effectiveness to improve overall nasal symptoms (daytime) [AR: Day 0 - Day 21]
AR: Assess effectiveness (daytime) to improve overall nasal symptoms in real world usage (6-point Likert scale)
- 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)
- Effectiveness to improve overall nasal symptoms (night-time) [AR: Day 0 - Day 21]
AR: Assess effectiveness (night-time) to improve overall nasal symptoms in real world usage
- 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)
- Effectiveness to improve quality of life [AR: Day 0 - Day 21]
AR: 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)
- Relief of nasal symptoms [URTI: Day 1 - Day 14]
URTI: 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)
- Onset of action & Duration [AR: Day 0 - Day 21]
AR: Assess Onset of action & Duration (2 closed questions)
- Safety of the medical device [URTI: Day 0 - Day 14]
URTI: occurence of incidents and deficiencies
- Tolerance [URTI: Day 14]
URTI: 1 question (numeric scale : 0-10)
- Safety of the medical device [AR: Day 0 - Day 21]
AR: occurence of incidents and deficiencies
- Tolerance [AR: Day 10 + Day 21]
AR: 1 question (numeric scale: 0-10)
- Usage [URTI: Day 0 - Day 14]
URTI: number of day of use, number of use/ day, number of puff/ nostril, moment of use
- Usage [AR: Day 0 - Day 21]
AR: 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)
- Patient satisfaction [AR: Day 10 + Day 21]
AR: 10 questions on Satisfaction (numeric scale: 0-10)
- Sensory profile [URTI: Day 14]
URTI: 4 questions on sensory profile (numeric scale: 0-10)
- Sensory profile [AR: Day 10 + Day 21]
AR: 4 questions on sensory profile (numeric scale: 0-10)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject coming to pharmacy for spontaneous purchase of one of the medical device under investigation.
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Subject willing to buy one of the medical device under investigation following advice from pharmacist, general practitioner or any other health care professionals.
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Adult and children from 3 years old in compliance with the information for use.
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Subject presenting moderate nasal congestion or more.
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Subject agreeing to follow the study requirements during the whole study period.
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Subject having daily access to internet in order to answer online questionnaire.
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Subject able to understand verbal and written local language and in capacity to fill-in questionnaire himself.
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Subject able to give inform consent.
Exclusion Criteria:
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Subject with contraindications according to the information for use.
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Hypersensitivity or know allergy to any component of the product.
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Subject taking part in another clinical study or being in the exclusion period of another clinical study.
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Subject already included once in this study or having a family member already included in this study for the same indication.
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Vulnerable subject (except children, pregnant and breastfeeding women).
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Laboratoire de la Mer
- Slb Pharma
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PMCF Hyper Mini