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.
Not Provided
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.
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.
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
Gaëlle NAELTEN, PharmD / PhD
+330633901291
gaelle.naelten@perrigo.com
Not Provided