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Completed

NCT Number: NCT06104332

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

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.

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic URTI

Age range

3 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alexandra Crevecoeur, Honfleur, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ProRhinel Naturel spray nasal/ Allergic rhinitis

Device

ProRhinel Naturel spray nasal: 21 days; 1 spray per nostril; 3 to 6 times per day

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

Primary outcomes

  1. URTI population : Effectiveness to improve nasal congestion

    Time frame: 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

  2. AR population: Effectiveness to improve nasal congestion

    Time frame: 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 outcomes

  1. Effectiveness to improve overall nasal symptoms (daytime)

    Time frame: URTI: Day 0 - Day 14

    URTI: Assess effectiveness (daytime) to improve overall nasal symptoms in real world usage (6-point Likert scale)

  2. Effectiveness to improve overall nasal symptoms (daytime)

    Time frame: AR: Day 0 - Day 21

    AR: Assess effectiveness (daytime) to improve overall nasal symptoms in real world usage (6-point Likert scale)

  3. Effectiveness to improve overall nasal symptoms (night-time)

    Time frame: URTI: Day 0 - Day 14

    URTI: Assess effectiveness (night-time) to improve overall nasal symptoms in real world usage (6-point Likert scale)

  4. Effectiveness to improve overall nasal symptoms (night-time)

    Time frame: AR: Day 0 - Day 21

    AR: Assess effectiveness (night-time) to improve overall nasal symptoms in real world usage

  5. Effectiveness to improve quality of life

    Time frame: URTI: Day 0 - Day 14

    URTI: Assess effectiveness to improve quality of life in real world usage (RQLQ self-administered questionnaire)

  6. Effectiveness to improve quality of life

    Time frame: AR: Day 0 - Day 21

    AR: Assess effectiveness to improve quality of life in real world usage (RQLQ self-administered questionnaire)

  7. Relief of nasal symptoms

    Time frame: AR: Day 1 - Day 21

    AR : assessment of nasal symptoms relief (7-point Likert scale)

  8. Relief of nasal symptoms

    Time frame: URTI: Day 1 - Day 14

    URTI: assessment of nasal symptoms relief (7-point Likert scale)

  9. Onset of action & Duration

    Time frame: URTI: Day 0 - Day 14

    URTI: Assess Onset of action & Duration (2 closed questions)

  10. Onset of action & Duration

    Time frame: AR: Day 0 - Day 21

    AR: Assess Onset of action & Duration (2 closed questions)

  11. Safety of the medical device

    Time frame: URTI: Day 0 - Day 14

    URTI: occurence of incidents and deficiencies

  12. Tolerance

    Time frame: URTI: Day 14

    URTI: 1 question (numeric scale : 0-10)

  13. Safety of the medical device

    Time frame: AR: Day 0 - Day 21

    AR: occurence of incidents and deficiencies

  14. Tolerance

    Time frame: AR: Day 10 + Day 21

    AR: 1 question (numeric scale: 0-10)

  15. Usage

    Time frame: URTI: Day 0 - Day 14

    URTI: number of day of use, number of use/ day, number of puff/ nostril, moment of use

  16. Usage

    Time frame: AR: Day 0 - Day 21

    AR: number of day of use, number of use/ day, number of puff/ nostril, moment of use

  17. Patient satisfaction

    Time frame: URTI: Day 14

    URTI: 10 questions on Satisfaction (numeric scale: 0-10)

  18. Patient satisfaction

    Time frame: AR: Day 10 + Day 21

    AR: 10 questions on Satisfaction (numeric scale: 0-10)

  19. Sensory profile

    Time frame: URTI: Day 14

    URTI: 4 questions on sensory profile (numeric scale: 0-10)

  20. Sensory profile

    Time frame: AR: Day 10 + Day 21

    AR: 4 questions on sensory profile (numeric scale: 0-10)

Sponsors and collaborators

Lead sponsor

Laboratoire de la Mer

Industry

Collaborators

  • Slb Pharma

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 27, 2023
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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