Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms

Official title

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

Overview

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.

Interventions

• Device 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
• Device 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
• Device 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
• Device Phytosun arôms® Hypertonic nasal wash
  1 second spray in each nostril, 2-3 times a day.

Primary outcome measures

• Real-life effectiveness to improve nasal symptoms in case of acute and chronic sinonasal pathologies. [Time frame: 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)]

Secondary outcome measures (12)

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

Eligibility criteria

Inclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

France · 32 centers

• 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
• … and 24 more centers

Identifiers

NCT: NCT07262450 · 2025-A00394-45

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗