Official Title
Real-word Study to Assess Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms
Brief Summary

The purpose of this post-market clinical investigation is to assess in a real-lifesetting, the effectiveness, usage, tolerance, safety and satisfaction of 4 isotonic andhypertonic 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.

Detailed Description

Not Provided

Recruiting
URTI
Bronchiolitis
COVID - 19
Allergic Rhinitis
Chronic Rhinosinusitis (CRS)
Post-surgery

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.

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.

Eligibility Gender
All
Eligibility Age
Minimum: 15 Days ~ Maximum: N/A
Countries
France
Locations

CHU Bordeaux
Bordeaux, France

Pharmacie de la Faïncerie
Bourg-la-Reine, France

Pharmacie Marine
Cabourg, France

Pharmacie Daguet
Châteauroux, France

Pharmacie des verts coteaux
Châtenay-Malabry, France

Pharmacie Lombard
Châtenay-Malabry, France

Maison Médicale Avicenne
Chevaigné, France

CHU de Clermont-Ferrand
Clermont-Ferrand, France

Kap Santé
Courrières, France

Pharmacie de la Liberté
Falaise, France

Maison médicale Heyrieux
Heyrieux, France

CHD Vendée
La Roche-sur-Yon, France

CKRF Marcq en Baroeul
Marcq-en-Barœul, France

Centre de Kinésithérapie spécialisé en rééducation respiratoire - Marseille
Marseille, France

La Maison du Souffle
Metz, France

Centre médical Chamberte
Montpellier, France

CHU Poitiers
Poitiers, France

Pharmacie du Pot d'Etain
Pont-Audemer, France

Pharmacie DRAPEAU
Pont-Saint-Martin, France

Cabinet de kinésithérapie respiratoire Sophie Jacques
Rennes, France

Pharmacie Deroche
Roézé-sur-Sarthe, France

Pharmacie Girard
Saint-Colomban, France

Clinique Saint-Jean
Saint-Jean-de-Védas, France

Centre de santé respiratoire Saint Paul Lès Dax
Saint-Paul-lès-Dax, France

Pharmacie des Corsaires
St-Malo, France

Pôle Santé de Réadaptation Toulouse Ouest
Toulouse, France

CRKF Tourcoing
Tourcoing, France

Maison médicale Belencontre
Tourcoing, France

Maison médicale de la Bourgogne
Tourcoing, France

Centre respiratoire de Valenciennes
Valenciennes, France

Cabinet de Kinésithérapie HODOROABA Vincent
Wissous, France

Pharmacie St-Exupery
Wissous, France

Contacts

Gaëlle NAELTEN, PharmD / PhD
+330633901291
gaelle.naelten@perrigo.com

Not Provided

NCT Number
MeSH Terms
Bronchiolitis
COVID-19
Rhinitis, Allergic