Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms

Официальное название

Real-word Study to Assess Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms

Обзор

The purpose of this post-market clinical investigation is to assess in a real-life setting, the effectiveness, usage, tolerance, safety and satisfaction of 4 isotonic and hypertonic seawater-based CE-marked nasal sprays. The main questions it aims to answer are: * Efficacy, * Safety, * Usage, * Satisfaction, in real-life usage among infants, children, adults and pregnant or breastfeeding women suffering from acute and chronic sinonasal pathologies. The 4 medical devices under investigation will be used in accordance with their intended use, target populations and medical indications.

Вмешательства

• Устройство Respimer® Hygiene-Prevention -Baby, kids, adults
  1-3 seconds spray in each nostril, * 4 to 6 times a day, in treatment of nasal symptoms. * 1 to 2 times a day, in hygiene and prevention
• Устройство Respimer® Hygiene-Prevention Kids, adults
  1-2 seconds spray in each nostril, * 4 to 6 times a day, in treatment of nasal symptoms * 1 to 2 times a day, in hygiene and prevention
• Устройство Respimer® Decongestion Baby, kids, adults
  Baby (2 months+): 1-3 seconds spray in each nostril, up to 3 times a day Children (2 y+) and adults: 1-3 seconds spray in each nostril, up to 6 times a day
• Устройство Phytosun arôms® Hypertonic nasal wash
  1 second spray in each nostril, 2-3 times a day.

Первичные конечные точки

• Real-life effectiveness to improve nasal symptoms in case of acute and chronic sinonasal pathologies. [Срок оценки: From Day 0 to Day 5 (acute indications: URTI, COVID-19, bronchiolitis) From Day 0 to Day 14 (chronic indications: allergic rhinitis, chronic rhinosinusitis, post-surgery)]

Вторичные конечные точки (12)

• Real-life effectiveness to reduce the intensity of individuals symptoms [Срок оценки: From Day 0 to Day 14]
• Real-life effectiveness to reduce the intensity of additional extra nasal symptoms [Срок оценки: From Day 0 to Day 14]
• Real-life effectiveness to reduce the intensity of eyes symptoms [Срок оценки: From Day 0 to Day 14]
• Real-life effectiveness to reduce the daily intensity of symptoms [Срок оценки: From Day 0 to Day 14]
• Real-life effectiveness to reduce the overall intensity of symptoms [Срок оценки: From Day 0 to Day 14]
• Real-life effectiveness to reduce the frequency of sneezing [Срок оценки: From Day 0 to Day 14]
• Real-life effectiveness to reduce the frequency of nose blowing [Срок оценки: From Day 0 to Day 14]
• Real-life effectiveness to reduce the frequency of cough [Срок оценки: From Day 0 to Day 14]
• Real-life effectiveness to relieve individual symptoms - Evolution [Срок оценки: From Day 0 to Day 14]
• Real-life effectiveness to relieve individual symptoms [Срок оценки: From Day 0 to Day 14]
• Real-life effectiveness to relieve individual symptoms - 1st relief [Срок оценки: From Day 0 to Day 14]
• Real-life effectiveness to improve nasal breathing [Срок оценки: From Day 0 to Day 14]

Критерии участия

Критерии включения

• Subject's age and medical condition in compliance with the intended use and population
• Subjects who, from the investigator's judgement, should benefit from nasal wash in accordance with routine medical practice
• Subjects with at least two nasal symptoms of intensity ≥ 3 (6 modalities intensity SNOT-22 rating-scale) among the following:

• Nasal blockage/nasal congestion/ stuffy nose;
• Runny nose;
• Need to blow/clear the nose;
• Sneezing;
• Thick nasal discharge/secretions;
• Decreased sense of smell /taste (replaced by "noisy breathing/mouth breathing" for infants)
• Subjects with impaired nasal breathing (score ≥ 3, 6-modalities intensity rating-scale), induced by the presence of nasal symptoms
• For acute indications (only): subjects with symptoms started not later than 72 hours prior to enrolment (Day 0).
• For allergic rhinitis indication: perennial allergic rhinitis with and without seasonal allergic rhinitis
• For post-surgery indication: septoplasty and rhinoseptoplasty.
• Subject/parent willing to perform nasal wash following advices received from HCPs.
• Subjects (or parents for babies and children) agreeing to follow the study requirements during the whole study period (up to 3 months).
• Subject (or parent for baby and children) able to understand verbal and written local language and in capacity to fill-in questionnaire by himself.
• Subject having daily access to internet to answer online questionnaire.
• Subject or Parent/legal guardian of the subject has given freely and expressly her/his informed consent.
• Subject affiliated to the health social security system or beneficiary of an equivalent system

Non-inclusion criteria:

• Subject with contraindications according to each IFU.
• Hypersensitivity or known allergy to any component of the investigational products.
• Subject taking part in another clinical study or being in the exclusion period of another clinical study.
• Subject already using nasal wash to manage his nasal symptoms.
• Subject already included once in the study.
• Subject with a member of his household already included in the study if still in the follow-up phase.
• Subject deprived of liberty by administrative or judicial decision or under legal guardianship.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 32 центра

• CHU Bordeaux — Bordeaux
• Pharmacie de la Faïncerie — Bourg-la-Reine
• Pharmacie Marine — Cabourg
• Pharmacie Daguet — Châteauroux
• Pharmacie des verts coteaux — Châtenay-Malabry
• Pharmacie Lombard — Châtenay-Malabry
• Maison Médicale Avicenne — Chevaigné
• CHU de Clermont-Ferrand — Clermont-Ferrand
• … и ещё 24 центра

Идентификаторы

NCT: NCT07262450 · 2025-A00394-45

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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