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

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06104332
• Other study ID #: PMCF Hyper Mini
• Status: Recruiting
• Start date: November 4, 2023
• Est. completion date: October 2024

Study information

• Verified date: November 2023
• Source: Laboratoire de la Mer
• Contact: Ophélie Flageul
• Phone: 0299121962
• Email: o.flageul[@]slbpharma.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 534
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Gender: All
• Age group: 3 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic
• URTI

Intervention

Device:
• ProRhinel Naturel spray nasal/ Allergic rhinitis
ProRhinel Naturel spray nasal: 21 days; 1 spray per nostril; 3 to 6 times per day
• 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
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
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
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
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
ProRhinel Naturel spray nasal: until resolution of symptoms (period of 14 days maximum) ; 1 spray per nostril; 3 to 6 times per day

Locations

Country	Name	City	State
France	Alexandra Crevecoeur	Honfleur
France	Annie Le Gall	Vern-sur-Seiche

Sponsors (2)

Lead Sponsor	Collaborator
Laboratoire de la Mer	Slb Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	Effectiveness to improve overall nasal symptoms (daytime)	AR: Assess effectiveness (daytime) to improve overall nasal symptoms in real world usage (6-point Likert scale)	AR: Day 0 - Day 21
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Relief of nasal symptoms	AR : assessment of nasal symptoms relief (7-point Likert scale)	AR: Day 1 - Day 21
Secondary	Relief of nasal symptoms	URTI: assessment of nasal symptoms relief (7-point Likert scale)	URTI: Day 1 - Day 14
Secondary	Onset of action & Duration	URTI: Assess Onset of action & Duration (2 closed questions)	URTI: Day 0 - Day 14
Secondary	Onset of action & Duration	AR: Assess Onset of action & Duration (2 closed questions)	AR: Day 0 - Day 21
Secondary	Safety of the medical device	URTI: occurence of incidents and deficiencies	URTI: Day 0 - Day 14
Secondary	Tolerance	URTI: 1 question (numeric scale : 0-10)	URTI: Day 14
Secondary	Safety of the medical device	AR: occurence of incidents and deficiencies	AR: Day 0 - Day 21
Secondary	Tolerance	AR: 1 question (numeric scale: 0-10)	AR: Day 10 + Day 21
Secondary	Usage	URTI: number of day of use, number of use/ day, number of puff/ nostril, moment of use	URTI: Day 0 - Day 14
Secondary	Usage	AR: number of day of use, number of use/ day, number of puff/ nostril, moment of use	AR: Day 0 - Day 21
Secondary	Patient satisfaction	URTI: 10 questions on Satisfaction (numeric scale: 0-10)	URTI: Day 14
Secondary	Patient satisfaction	AR: 10 questions on Satisfaction (numeric scale: 0-10)	AR: Day 10 + Day 21
Secondary	Sensory profile	URTI: 4 questions on sensory profile (numeric scale: 0-10)	URTI: Day 14
Secondary	Sensory profile	AR: 4 questions on sensory profile (numeric scale: 0-10)	AR: Day 10 + Day 21